ES2894640T3 - Proprioceptive/kinesthetic apparatus and method - Google Patents

Abstract

A shoe (10) comprising: a support member (12) having an inner sole and an upper surface attachable to a foot, and two bulbous protrusions (22, 218, 220), a front bulbous protrusion (22 , 218) and a rear bulbous protrusion (22, 220), each having a curved outer contour, protruding from a lower surface of said support member on opposite sides of a latitudinal midline (30) thereof, said line latitudinal median (30) that is midway between a calcaneal support portion and a phalangeal support portion of said support member, wherein said forward bulbous protrusion (22, 218), said rear bulbous protrusion (22, 220 ) or both are positioned offset relative to a longitudinal center line (28), wherein the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous protrusion of the two bulbous protrusions (22, 218, 220) is less than 12:1, wherein at least one of the two bulbous protrusions (22, 218, 220) has a Shore hardness of between 15 and 100 Sh A and an abrasion resistance greater than 80 mm3 and less than 125 mm3 according to DIN 53516, said footwear (10) that is adapted to support the foot only by means of said two bulbous protuberances (22, 218, 220) when said two protuberances (22, 218, 220 ) are placed on a ground surface.

Description

DESCRIPTION

Proprioceptive/kinesthetic apparatus and method

field of invention

The present invention relates generally to an apparatus for training, developing, and improving proprioceptive and kinesthetic abilities, neuromuscular control, and core stability.

Background of the invention

Proprioception refers to the ability to know where a body part is in space and to recognize the movements of body parts (such as fingers and toes, feet and hands, legs and arms). Kinesthesia is a related term and refers to the sensation by which position, weight, muscle tension, and movement are perceived. In some of the medical literature, proprioception refers to the conscious and unconscious appreciation of joint position, while kinesthesia refers to the sensation of joint speed and acceleration. Proprioception is often used interchangeably with kinesthesia, and also in the present description, the terms will be used interchangeably. (Throughout the specification and claims, the term "proprioception" will be used to encompass proprioception, kinesthesia, core stability, and the like.)

The body's neuromuscular control system integrates peripheral sensations related to joint loads and processes these signals into coordinated motor responses. This muscular activity serves to protect the joint structures from excessive stress.

Certain mechanoreceptors are present in the soft tissues of the musculoskeletal system that interact with the central nervous system and coordinate body movements, postural alignment, and balance. Mechanoreceptors are found in muscles, tendons, ligaments, joint capsules, and skin. These nerve fibers provide information to the brain about the status and function of the musculoskeletal system. Mechanoreceptors send electrical signals along peripheral nerves to the spinal cord. The electrical signals travel through the spinal cord to the brain, where the signals are interpreted to recognize movements of body parts, muscle tension, movement, and the like.

Some examples of mechanoreceptors to control the muscular system include muscle spindles. Muscle spindles are interspersed within the contractile fibers of skeletal muscles, with the highest concentration in the central portion of each muscle. Muscle spindle fibers respond to changes in muscle length. These nerve endings provide the information from the central nervous system that is used to maintain correct muscle tone and muscle tension on opposite sides of each joint.

The fibrous tissues that surround and protect most joints generally contain a variety of sensory nerve endings for proprioception and kinaesthesia. Input from these sensory nerve endings provides information to the central nervous system regarding joint location, stretch, compression, tension, acceleration, and rotation.

The foot is the anatomical region that contains the second largest number of proprioceptive or kinesthetic sensory receptors in the body (the spine has more).

Proprioceptive and kinesthetic exercises and exercise devices are well known for improving agility, balance, and coordination, and for the rehabilitation of people whose proprioceptive ability has been impaired, such as after accidents or illness. One of these classes of exercise devices includes tilt boards, in which a patient stands on a board or similar platform that has a ball mounted underneath. The board is not horizontal due to the presence of the ball, and this challenges the patient's ability to balance and maneuver on the board. Repeated rocker board exercises can be used to develop or rehabilitate the patient's proprioception and neuromuscular control, as well as to strengthen the muscles, tendons, and connective tissues in the foot area.

Other known proprioceptive and kinesthetic exercise devices include a shoe with a single ball mounted under the sole of the shoe. The ball shoe is used similarly to the toggle board. Another type of shoe has a rod mounted under the sole of the shoe, which is used to strengthen the dorsiflexor muscles.

Another proprioceptive and kinesthetic exercise device is described in US Pat. 6,283,897 to Patton. This device consists of one or more pins that protrude upwards from a socket. The pegs have a rounded top and sit in concave depressions (divots) in the bottom of a sandal-shaped shoe cover. Specifically, the bottom of the shoe sole has three divots hemisphere-shaped concaves, one located within the heel portion, one directly below the ball of the foot, and one located in the center. The elastomeric bands can support the user's foot as the user rotates the foot and/or hips to develop strength, range of motion, and proprioception of the ankle and hips. US 2010/325919 A1 discloses a shoe comprising a support member having an inner sole and an upper surface attachable to a foot, and two bulbous nubs, a forward bulbous nub and a rear bulbous nub, each one of which has a curved outer contour, projecting from a lower surface of said support member on opposite sides of a latitudinal midline thereof, said latitudinal midline being midway between a calcaneal support portion and a portion of phalanx support of said support member, wherein said forward bulbous protrusion, said rear bulbous protrusion, or both are positioned offset from a longitudinal centerline.

Summary of the invention

Thus, there is provided, according to the present invention, a shoe comprising the features of claim 1 and a method comprising the features of claim 9. Advantageous features are recited in the dependent claims.

Also, according to embodiments of the present invention, the longitudinal centerline is defined as a longitudinal straight line connecting mid-short sides of a rectangle delimiting an outline of the support member.

Also, according to embodiments of the present invention, the outline is an outline of a fulcrum bounded by an upper part of the shoe.

Also, according to embodiments of the present invention, the contour is an outermost contour of the shoe.

Also, according to embodiments of the present invention, the contour is the contour of a lower surface of the sole of the shoe.

Furthermore, according to embodiments of the present invention, the height of the forward bulbous protrusion is greater than the height of the rear bulbous protrusion.

Furthermore, according to embodiments of the present invention, the height of the rear bulbous protrusion is greater than the height of the front bulbous protrusion.

Brief description of the drawings

The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the accompanying drawings in which:

Figure 1 is a simplified pictorial illustration of a shoe constructed and operative in accordance with one embodiment of the present invention;

Figures 2 and 3 are simplified side view and rear view illustrations, respectively, of the shoe of Figure 1;

Figure 4 is a simplified top view illustration of the shoe of Figure 1, showing additional features of other embodiments of the present invention;

Figure 5 is a simplified pictorial illustration of a treadmill constructed and operative in accordance with one embodiment of the present invention;

Figure 6 is a simplified pictorial illustration of an exercise surface constructed and operative in accordance with one embodiment of the present invention;

Figure 7 is a simplified pictorial illustration of an exercise bicycle constructed and operative in accordance with one embodiment of the present invention;

Figure 8 is a simplified pictorial illustration of an exercise stair climber constructed and operative in accordance with one embodiment of the present invention;

Figure 9 is a simplified pictorial illustration of a ski machine constructed and operative in accordance with one embodiment of the present invention;

Figure 10 is a simplified pictorial illustration of an elliptical exercise machine constructed and operative in accordance with one embodiment of the present invention; and

Figure 11 is a simplified pictorial illustration of a rowing machine constructed and operative in accordance with one embodiment of the present invention.

Figure 12 is a simplified pictorial illustration of an alignment of anterior (forward) and posterior (rearward) bosses on a support member, in accordance with embodiments of the present invention.

Figure 13 is a simplified pictorial illustration of another alignment of anterior and posterior bosses on a support member, in accordance with embodiments of the present invention.

Figure 14 is a simplified pictorial illustration of an athletic shoe constructed and operative in accordance with one embodiment of the present invention, the rear bulge having a height greater than the height of the front bulge.

Figure 15 is a simplified pictorial illustration of an athletic shoe constructed and operative in accordance with one embodiment of the present invention, the front bulge of which has a height greater than the height of the rear bulge.

Figure 16 illustrates the limits of the maximum positioning area of the anterior and posterior protrusions with respect to a support surface, according to embodiments of the present invention.

Figure 17 illustrates the limits of the effective area of positioning of the anterior and posterior protrusions with respect to a support surface, according to embodiments of the present invention.

Figure 18A is an isometric view of a bulge suitable for use in a shoe, according to embodiments of the present invention.

Figure 18B is a front view of a bulge suitable for use in a shoe, according to embodiments of the present invention.

Figure 18C is a side view of a bulge suitable for use in a shoe, according to embodiments of the present invention.

Figure 19 are graphs defining the convexity of a bulge suitable for use in a shoe, in accordance with embodiments of the present invention. The first graph 1000 illustrates the function f ( x } = %¡Sx (1)

f {x) = ljx '

and the second graph 1002 illustrates the function 'The circumference of the bulge is at x, y = 0 for both functions. The vertex of the bump is at x = m for both functions, while the y-axis value of the vertex can be between n1 for function (1) and n2 for function (2).

Detailed description of the present invention

Reference is now made to Figures 1-4, which illustrate footwear 10 constructed and operative in accordance with one embodiment of the present invention. The shoe 10 may be supplied as one or more pairs of shoe-like devices, or alternatively, as only one of the shoe-like devices.

The shoe 10 preferably comprises a support member 12 having a shoe-sole-shaped periphery with an upper surface 14. In the illustrated embodiment, the upper surface 14 is indented with a peripheral rim 16, but other configurations are appreciated. of the top surface 14 are within the scope of the invention. Footwear 10 may be attached to a wearer's foot (not shown) by means of a boot 18 and/or fasteners 20, such as, but not limited to, VELCRO straps, buckles, shoelaces, and the like. Boot 18 can be made to attach to the wearer's foot with or without fasteners 20. Similarly, fasteners 20 can be used to attach footwear 10 to the wearer's foot without boot 18.

In another embodiment, the shoe comprises an inner sole (insole) and an outer sole. In another embodiment, the insole is equivalent to the maximum contour line that defines the representative shoe last or last. In one embodiment, the footwear is a shoe or a pair of shoes.

In another embodiment, the shoe comprises an outsole (outsole). In another embodiment, the outsole is the contour line that borders the surface of a shoe that faces the ground. In another embodiment, the outsole is the layer that faces the ground. In another embodiment, the base of a protrusion comes into contact with the outsole. In another embodiment, a spacer contacts the outsole. In another embodiment, a bulge extends from the outsole. In another embodiment, outsole is synonymous with "perimeter outsole" or "the contour line of the edge of a shoe's surface that faces the ground" or "ground outsole" or "the layer that faces toward the ground" or "layer adapted to attach to a ground surface".

Two bulbous protrusions 22 protrude from a lower surface 24 of support member 12. Each protrusion 22 has a curved outer contour 26. The cross section of the contour 26, that is, the cross section taken with respect to a longitudinal axis 28 (FIG. 4 ) of the support member 12 (corresponding to the shape seen in Figure 2) or the cross section taken with respect to a latitudinal axis 30 (Figure 4) of the support member 12 (corresponding to the shape seen in Figure 3), or any other cross section, it can have any curvilinear shape. For example, the contours 26 may have the shape of a conic section, ie, the shape of a circle, ellipse, parabola, or hyperbola. The various cross sections of the contours 26 of the protrusion 22 may have an identical or different shape.

As clearly seen in Figure 2, one protrusion 22 is positioned more posteriorly than the other protrusion 22. As seen in Figure 4, the protrusions are positioned on a common longitudinal axis of support member 12, such as the center line 28 of the support member 12 and on opposite sides of the latitudinal midline 30. As seen in Figure 2, the rear boss 22 may be positioned generally below a calcaneal (heel, ankle) bearing portion 23 of the support member. 12, while the forward boss 22 may be positioned generally below a metatarsal support portion 25 and/or a phalangeal support portion 27 of the support member 12.

In accordance with embodiments of the present invention, the longitudinal centerline is defined as a longitudinal straight line connecting mid-short sides of a rectangle delimiting an outline of the support member.

Alternatively, as indicated by the dashed lines 33 in Figure 4, one of the bosses 22 (for example, the front one) may be aligned on a longitudinal axis 34 offset from the center line 28, and the rear boss 22 may be positioned offset from the center line 28. axis 34, such as center line 28. It is appreciated that the foregoing are only a few examples of positioning the protrusions 22, and many other possibilities exist within the scope of the invention.

The protrusions 22 may be constructed of any suitable material within the scope of the claims, such as, but not limited to, elastomers or metal or a combination of materials, and may have different properties. For example, the protrusions may have different elasticity or hardness, such as having different elasticity or Shore hardness properties. The protrusions 22 may protrude by different amounts from the lower surface 24 of the support member 12.

In accordance with one embodiment of the present invention, one or more bosses 22 may be slidably mounted on support member 12. For example, boss 22 may be mounted on a track 36 (FIG. 2) formed on the bottom surface 24 of the support member. support member 12, and can be selectively placed anywhere along the track and attached thereto. The track 36 may extend along a portion of the sole of the shoe or along the sole of the shoe. Alternatively or additionally, the amount of protrusion of a boss 22 may be adjusted, for example, such as by mounting the boss 22 with a threaded fastener 38 (FIG. 3) to the support member 12 and tightening or loosening the threaded fastener 38.

In accordance with one embodiment of the present invention, in addition to the bulbous protrusions 22, one or more non-bulbulous protrusions 39, shown in Figure 3, may also be provided. The protrusions 39 may be formed in the form of a pin, stud, bolt, pin, dowel and the like, although the invention is not limited to these shapes. The protrusions 39 can be rigid or flexible. As with the protrusions 22, the protrusions 39 may have different elasticity or hardness, such as having different elasticity or shore hardness properties, and may protrude by different amounts from the lower surface 24 of the support member 12. As before, you can adjust the amount of protrusion of the protrusions 39. The protrusions 39 may be mounted anywhere on the bottom surface 24 of the support member 12, but within the text of the claims.

The features described above, such as the protrusions 22 slidably mounted on the support member 12, may be implemented in the alternative embodiment not forming part of the invention where the bulbous protrusions 22 protrude from the upper surface 14 of the support member. 12. For example, the shoe 10 may have a normal outsole and have a slide/change mechanism for the nubs 22 within the sole of the shoe 10. The slide/change mechanism may comprise, without limitation, a floating mechanism in a viscous matrix (for example, fluid in a chamber formed in the sole), or that is suspended by internal cables.

Reference is now made to Figure 4. In accordance with one embodiment of the present invention, the shoe 10 may comprise a flange 40 extending outwardly from the periphery of the support member 12. In the illustrated embodiment, the flange 40 is it extends laterally outwardly from the periphery of support member 12, but it is appreciated that flange 40 may extend forwards or backwards or in any other direction as well. The flange 40 may be provided on one side of the shoe 10, as illustrated, or it may be provided on both sides. The flange 40 may supplement the range of proprioceptive exercises possible with the shoe 10 by providing an additional support surface during leaning and maneuvering with the shoe 10. The flange 40 may be constructed of any suitable material, such as, but not limited to a, elastomers or metal or a combination of materials, and may have portions 42 with different properties. For example, the portions 42 may have different elasticity or hardness, such as having different elasticity or Shore hardness properties. The portions 42 of the flange 40 may have differently curved contours. Flange 40 is adjustably attachable to support member 12 such that the extension of flange 40 from support member 12 is adjustable.

A user can attach the shoe 10 to his or her foot and perform a variety of maneuvers in a proprioceptive and/or kinesthetic exercise plan for the lower foot, upper leg, and even upper torso and other parts and body organs. For example, footwear 10 can be used to restore neuromuscular control during joint rehabilitation, to restore mechanical and functional stability of the neuromuscular system, to enhance or rehabilitate anticipatory (proaction) and reflexive (feedback) neuromuscular control mechanism, and to restore and improve balance, postural balance, and core stability.

Reference is now made to Figure 5, which illustrates a treadmill 50 which is not part of the present invention. Treadmill 50 may comprise a foot contact running surface 52 that rotates about a pair of spaced-apart pulleys 54. Running surface 52 may comprise one or more protrusions 56 projecting upwardly from running surface 52. Protrusions 56 may have a different or similar configuration (eg, height, size, shape, and/or slope). The protrusions 56 may have a fixed size/shape or, alternatively, may have a variable size/shape. The variable size/shape can be achieved by constructing a bulge 56 from an inflatable element, which can be inflated pneumatically with air or hydraulically with a liquid (eg, water or oil). A controller 58 may be provided which controls the inflation and deflation of the nubs 56. The nubs 56 and/or the running surface 52 may have different or similar material properties. For example, they can have a different or similar elasticity or viscosity (in the inflatable version) and can be made of different or similar materials.

The protrusions 56 may be mobile. For example, one or more of the bumps 56 may translate such as on a track 57 (for example, forwards, backwards, sideways, or diagonally) and/or rotate about its own or another axis, or a combination of these. such movements. a protective strap

(not shown) may be provided to keep the user upright and help prevent accidental falls.

Reference is now made to Figure 6, which illustrates an exercise surface 60 which is not part of the present invention. The exercise surface 60 may comprise one or more protrusions 62 projecting upwardly from the upper (foot-contacting) face and/or the lower (ground-contacting) face of the exercise surface 60. The protrusions 62 they may have a different or similar configuration (eg, height, size, shape, and/or slope). The protrusions 62 may have a fixed size/shape or, alternatively, may have a variable size/shape. The variable size/shape can be achieved by constructing a bulge 62 from an inflatable element, which can be inflated pneumatically with air or hydraulically with a liquid (eg, water or oil). A controller 64 may be provided which controls the inflation and deflation of the bulges 62. The bulges 62 may have a different or similar elasticity or viscosity (in the inflatable version) and may be made of different or similar materials.

The protrusions 62 may be mobile. For example, one or more of the bumps 62 may translate such as on a track 66 (eg, forwards, backwards, laterally, radially, or diagonally) and/or rotate about its own axis or another axis, or a combination. of such movements. A user of exercise surface 60 can thus move in six degrees of freedom (moving in three mutually orthogonal directions (x, y, z) and rotating about these axes (azimuth, elevation, and roll)).

Reference is now made to Figure 7, which illustrates an exercise bike 70 which is not part of the present invention. Exercise bike 70 may comprise a device with its own pedals, wheel, and sensors (eg, speedometer, odometer, etc.) or it may comprise an indoor bicycle trainer, in which a user mounts a bicycle on a stand, that allows the bicycle to be pedaled while the bicycle remains stationary. The exercise bike 70 may comprise an impact mechanism 72 connected to a front axle 74 or rear mount 75 of the bike 70 and/or an impact mechanism 76 connected to a seat 78 of the bike. bicycle 70. The impact mechanisms can oscillate, sway, bump, and otherwise upset the balance of the user of the exercise bicycle 70 (as indicated by arrows in Figure 7). The impact mechanisms can move the cyclist in six degrees of freedom (translation in three mutually orthogonal directions (x, y, z) and rotation around these axes (azimuth, elevation and roll)). The impact mechanisms in this embodiment, as in other embodiments of the invention, may comprise a plate to which the exercise bike 70 is mounted, the plate providing the impact action in six degrees of freedom.

The exercise bike 70 can be used to exercise neuromuscular control in the back, hip, pelvis, ankle, knee and other parts of the body by shocks while driving, which can simulate driving on bumpy roads. A controller 77 may be provided to control the operation of the impact mechanism 72.

Reference is now made to Figure 8, which illustrates an exercise stair climber 80, which forms no part of the present invention. The exercise stair climber 80 may comprise a controller 82 that varies the resistive force offered by the pedals 84 of the stair climber 80. The controller 82 may also vary the angle of the pedals 84, to create eversion and inversion, as indicated by arrows on Figure 8. Here too, controller 82 can move pedals 84 in six degrees of freedom (translation in three mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth, yaw, and roll)).

Reference is now made to Figure 9, which illustrates a ski machine 90, which forms no part of the present invention. The ski machine 90 may comprise a controller 92 that varies the resistance force offered by the ski decks 94 of the ski 90. The controller 92 may also vary the angle of the ski decks 94, to create eversion and inversion, as shown. indicated by arrows in Figure 9. The controller 92 can move the ski decks 94 in six degrees of freedom (translation in three mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth, elevation and roll) ).

Some exercise experts have noted various drawbacks of prior art exercise equipment. For example, stationary exercise bikes can use only a relatively small number of muscles, in a fairly limited range of motion. Cross-country ski devices can exercise more muscles than a stationary bicycle, however, the substantially flat trailing foot motion of the device may limit the range of motion of some of the muscles being exercised. Stair climbing devices can exercise more muscles than stationary bikes, however, the limited range of motion up and down may not exercise the leg muscles through a full range of motion.

In response to these concerns, elliptical exercise machines have been developed that simulate the natural movements of walking and running and exercise a large number of muscles through a wide range of motion. The machines provide a flexibly coordinated and variable elliptical motion of the leg muscles. An example of one of the many prior art elliptical exercise machines is described in US Pat. 5,848,954.

Reference is now made to Figure 10, which illustrates an elliptical exercise machine 100, which forms no part of the present invention. The elliptical exercise machine 100 is shown for convenience with some elements similar to those in US Pat. 5,848,954.

Elliptical exercise machine 100 may comprise a frame 102 and a link assembly 104 movably mounted to frame 102. Link assembly 104 may move generally relative to frame 102 in a manner that links rotation of a flywheel 106 with the generally elliptical movement of a force receiving member or "skid" 108. The frame 102 may include a base 110, a front post or post 112 and a rear post or post 114.

It is noted that the term "elliptical motion" is intended in a broad sense to describe a closed path of motion having a relatively longer first axis and a relatively shorter second axis (extending perpendicular to the first axis). It is further noted that in the illustrated embodiment, there is left-right symmetry about a longitudinal axis, and the "right side" components are 180 degrees out of phase with the "left side" components. However, the same reference numerals are used to designate "right" and "left" portions on the elliptical exerciser 100, and when reference is made to one or more portions on a single side of the machine, it is to be understood that the corresponding part(s) is(are) arranged on the opposite side of the machine.

Front post 112 may extend perpendicularly upwardly from base 110 and support a telescoping tube or post 116. A pair of handles 118 may be rotatably mounted on post 116 at pivot 119. Handles 118 may have grip portions 120 A screen 122 may be disposed on post 116. Skates 108 may slide on rails 124. A user may place their foot on a surface 126 of skate 108 that contacts the foot.

The elliptical exercise machine 100 may comprise one or more impact mechanisms 130 connected to a front mount 132 and/or a rear mount 134 of the rails 124. The impact mechanisms 130 may oscillate, rock, bump, and otherwise alter the balance of the user of the elliptical exercise machine 100. The impact mechanisms 130 can move the user in six degrees of freedom (translation in three mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth, elevation and y). swinging)). A controller 136 may be provided to control the operation of the impact mechanism 130.

Reference is now made to Figure 11, which illustrates a rowing machine 150, which forms no part of the present invention. The rowing machine 150 may comprise a rail 152 on which a seat 154 is slidably mounted. The rail 152 may have a rear support 155. The rail 152 may extend from a forward mounted tension drum 156, which may be mounted on a front support 157. A rope 158 can be wound around the tension drum 156. The rope 158 can be provided with a handle 159. The footrests 160 can be mounted on the rail 152.

A user (not shown) may sit on seat 154, place feet against footrests 160, grasp handle 159, and pull rope 158 toward the rear of rowing machine 150, away from tension drum 156. This move simulates the action of pulling the oars on a rowboat. Seat 154 can slide back and forth on rail 152 during the rowing motion. The tension drum 156 resists the pulling action on the rope 158, thereby exercising the muscles used in rowing. The tension on the tension drum 156 can be adjusted to suit the desired level of exercise. A controller 162 may be provided that varies the resistive force offered by the tension drum 156.

Rowing machine 150 may comprise one or more impact mechanisms 164 connected to front mount 157 and/or rear mount 155 of rail 152, or seat 154. Impact mechanisms 164 may oscillate, sway, bump, and otherwise alter. balance of the user of the rowing machine 150. The impact mechanisms 164 can move the user through six degrees of freedom (translation in three mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth, elevation and rocking)). Controller 162 may control the operation of impact mechanisms 164.

In accordance with the present invention, at least two bulbous protrusions 22 protrude from a lower surface 24 of support member 12. In some embodiments of the present invention, only two bulbous protrusions 22 protrude from a lower surface 24 of support member 12. In some embodiments of the present invention, a bottom surface of the support member is a sole. In some embodiments of the present invention, only two bulbous protrusions 22 protrude from a lower surface 24 of support member 12. In some embodiments of the present invention, the ground-engaging portions of the device are only the bulbous protrusions 22. In In some embodiments of the present invention, during all phases of gait, including the stance phase, the bulbous protrusions 22 are the only parts of the device that engage the ground. In some embodiments of the present invention, during all phases of gait, including the stance phase, the bulbous protrusions 22 are the only parts of the device that are in direct contact with the ground.

In another embodiment, the protrusions described in the present description are not pins. In another embodiment, each shoe of the inventive footwear comprises two bulbous nubs.

In another embodiment, the invention provides for the device, such as footwear 10, to support a subject's foot by only the two nubs when the two nubs are placed on a ground surface. In another embodiment, the invention provides for the device, such as footwear 10, to support a subject's foot during stance by only the two nubs when the two nubs are placed on a ground surface. In another embodiment, the invention provides that during stance only the 2 ground contact surfaces of the bumps (such as the beak or the ground facing surface) are in contact with a ground surface. In another embodiment, the invention provides that during stance only the ground contact surface on each bump is in contact with a ground surface. Each possibility represents a separate embodiment of the present invention.

In accordance with the invention, at least two bulbous protrusions 22 protrude from a lower surface 24 of support member 12. In another embodiment, only two bulbous protrusions 22 protrude from a lower surface 24 of support member 12.

In another embodiment, the outsole is a surface having no openings or openings adapted to receive additional protrusions other than the two bulbous protrusions 22. In another embodiment, the outsole is a surface having no protrusions other than the two bulbous protrusions 22. .

In some embodiments of the present invention, a protrusion as described herein is mobile. In some embodiments of the present invention, a boss may be mounted as described herein. In some embodiments of the present invention, a protrusion may be replaced as described herein. In some embodiments of the present invention, a protrusion as described in the present description can move along the outer surface of the support member. In some embodiments of the present invention, a nub as described herein may move along the outer surface of the sole. In some embodiments of the present invention, a protrusion as described herein may be positioned within the outer surface of the support member.

una protuberancia es móvil dentro 1 cm2 a 18 cm2 algunas modalidades de la presente invención,

una protuberancia es móvil a de 1 cm2 algunas modalidades de la presente invención,

una protuberancia es móvil a de 1 cm2 algunas modalidades de la presente invención,

una protuberancia es móvil a de 2 cm2 algunas modalidades de la presente invención,

una protuberancia es móvil a de 3 cm2 algunas modalidades de la presente invención,

una protuberancia es móvil dentro 4 cm2 a 10 cm2 algunas modalidades de la presente invención, una protuberancia es móvil dentr

5 cm2 a 18 cm2 algunas modalidades de la presente invención, una protuberancia es móvil dentro de un área dIn some embodiments of the present invention, a protrusion is fixed at a predetermined location. In some embodiments of the present invention, a protrusion can move within a predefined area. In some embodiments of the present invention,

a protuberance is mobile within 1 cm2 to 18 cm2 some embodiments of the present invention,

a bulge is mobile at 1 cm2 some embodiments of the present invention,

a bulge is mobile at 1 cm2 some embodiments of the present invention,

a bulge is mobile at 2 cm2 some embodiments of the present invention,

a bulge is mobile at 3 cm2 some embodiments of the present invention,

a nub is mobile within 4 cm2 to 10 cm2 some embodiments of the present invention, a nub is mobile within

5 cm2 to 18 cm2 some embodiments of the present invention, a protrusion is mobile within an area d

In some embodiments of the present invention, the predefined area within which the protrusion can move is a circle. In other embodiments, a predefined area within which the bump can move is a square. In other embodiments, a predefined area within which the bulge can move is an ellipse. In other embodiments, a predefined area within which the bulge can move is a rectangle. In other embodiments, a predefined area within which the bulge can move is quadrangular.

In some embodiments, the boss is hooked to a rail. In some embodiments, the boss is connected to a rail. In some embodiments, the boss is connected to a rail and can move along the rail. In some embodiments, the boss is connected to a rail, can be moved along the rail, and can be positioned and/or fixed anywhere along the rail.

In another embodiment, a protrusion may be attached anywhere on the support member, but within the limits defined in the claims. In another embodiment, a protrusion can be placed and/or fixed anywhere within a predefined area, but within the limits defined in the claims.

In another embodiment, the device comprises at least one anterior bulge and a movable/relocatable posterior bulge. In another embodiment, the device comprises at least one movable/relocatable anterior bulge and a posterior bulge. In another embodiment, the device comprises a movable/relocatable anterior bulge and a movable/relocatable posterior bulge. In another embodiment, the device comprises a movable/relocatable anterior bulge and a movable/relocatable posterior bulge. Each possibility represents a separate embodiment of the present invention. In another embodiment, the term "comprises" may include the term "consists."

As clearly seen in Figure 2, one bulge 22 is positioned more posteriorly than the other bulge 22. In embodiments, the device includes an anterior bulbous bulge and a posterior bulbous bulge. In other embodiments, the device comprises at least one anterior bulbous protrusion and a movable posterior bulbous protrusion. In other embodiments, the device comprises at least one movable anterior bulbous protrusion and a posterior bulbous protrusion. In other embodiments, the device comprises at least one movable anterior bulbous protrusion and a movable posterior bulbous protrusion. In other embodiments, the device includes a movable anterior bulbous protrusion and a movable posterior bulbous protrusion.

In some embodiments, the longitudinal centerline is defined as a straight longitudinal line connecting the midpoints of the short sides of a rectangle that defines an outline of the support member. The contour of the support member is defined, in some embodiments, as a fulcrum confined by a shoe upper. The contour of the support member is defined, in some embodiments, as an outermost contour of the shoe. The contour of the support member is defined, in some embodiments, as the contour of a bottom surface of a shoe sole.

In some embodiments, the protrusions rise vertically, each protrusion including a base end and a peak end. In some embodiments, the surface area of the base is greater than the surface area of the peak. In some embodiments, the peak is the ground contact portion of a bump.

In some embodiments, each protrusion 22 has a curved outer contour 26. In some embodiments, each protrusion 22 has a different curved outer contour. In some embodiments, each protrusion 22 has a convexity. In some embodiments, each protrusion 22 has a different convexity. The cross section of the outline 26, that is, the cross section taken with respect to a longitudinal axis 28 (Figure 4) of the support member 12 (corresponding to the shape seen in Figure 2) or the cross section taken with respect to

relative to a latitudinal axis 30 (FIG. 4) of the support member 12 (corresponding to the shape seen in FIG. 3), or any other cross section, it may have any curvilinear shape. In some embodiments, the contours 26 may be in the shape of a conic section, ie, the shape of a circle, ellipse, parabola, or hyperbola. The various cross sections of the contours 26 of the protrusion 22 may have an identical or different shape.

In some embodiments, as seen in Figure 4, the bosses are positioned on a common longitudinal axis of support member 12, such as centerline 28 of support member 12. In some embodiments, the bosses are positioned on opposite sides of the latitudinal midline 30. In some embodiments, the bosses are positioned offset from the centerline 28 of the support member 12, and on opposite sides of the latitudinal midline 30. In some embodiments, the meaning of "the boss is placed offset from center line" means that the peak or ground contact surface of a protuberance is positioned offset from the center line. In some embodiments, the meaning of "bump is positioned offset from centerline" comprises that only the peak or ground contact surface of a bump is positioned offset from centerline but the centerline still crosses the bump. In some embodiments, the bases of the bosses are positioned on the center line of the support member. In some embodiments, the peaks of the bosses are positioned on opposite sides of the centerline of the support member. In some embodiments, the central line longitudinally divides the calcaneal support portion into two equal halves and further extends to the phalanges and metatarsal support portion in a straight line. In some embodiments, the central line longitudinally divides the arch of the calcaneal support portion into two equal halves and further extends to the phalanges and metatarsal support portion in a straight line. In some embodiments, the central line longitudinally divides the proximal arch of the calcaneal support portion into two equal halves and further extends to the phalanges and metatarsal support portion in a straight line. In some embodiments, the center line longitudinally divides the bearing portion as seen in Figure 4 of the calcaneal bearing portion into two equal halves and further extends to the phalanges and metatarsal bearing portion in a straight line.

In some embodiments, the bases of the bumps are positioned on the centerline of the support member and the peaks of the bumps are positioned on opposite sides of the centerline of the support member. In some embodiments, the bases of the bumps are positioned on the centerline of the support member but the peaks of the bumps are offset from the centerline of the support member. In some embodiments, the bases of the bumps are positioned on the centerline of the support member but the peaks of the bumps are positioned on opposite sides of the centerline of the support member.

In some embodiments, the anterior boss is positioned medially from the centerline of the support member. In some embodiments, the peak of the anterior bulge is positioned medially from the centerline of the support member. In some embodiments, the base of the anterior bulge is positioned on the centerline of the support member, but the peak of the anterior bulge is positioned medially from the centerline of the support member. In some embodiments, the anterior boss is positioned laterally from the centerline of the support member. In some embodiments, the peak of the anterior boss is positioned laterally from the centerline of the support member. In some embodiments, the base of the anterior bulge is positioned on the centerline of the support member, but the peak of the anterior bulge is positioned laterally from the centerline of the support member. In some embodiments, the posterior boss is positioned medially from the centerline of the support member. In some embodiments, the peak of the posterior hump is positioned medially from the centerline of the support member. In some embodiments, the base of the posterior hump is positioned on the centerline of the support member, but the peak of the posterior hump is positioned medially from the centerline of the support member. In some embodiments, the rear boss is positioned laterally from the centerline of the support member. In some embodiments, the peak of the posterior bulge is positioned laterally from the centerline of the support member. In some embodiments, the base of the posterior hump is positioned on the centerline of the support member, but the peak of the posterior hump is positioned laterally from the centerline of the support member.

In some embodiments, the term athletic shoe encompasses a boot. In some embodiments, the term athletic shoe comprises a walking boot. In some embodiments, the athletic shoe comprises a running shoe platform.

In some embodiments, the parts of the device that engage the ground are just the bumps. In some embodiments, during all phases of gait, including the stance phase, the bumps are the only parts of the device that engage the ground. In some embodiments, during the stance phase, the bumps are the only parts of the device that engage the ground. Each possibility represents a separate embodiment of the present invention.

In some embodiments, a protrusion is mobile within a predefined area. In some embodiments, a bulge is mobile within an area of 1 cm2 to 18 cm2. In some embodiments, a bulge is mobile within an area of 1 cm2 to 6 cm2. In some embodiments, a bulge is mobile within an area of 1 cm2 to 4 cm2 In some embodiments, a lump is mobile within an area of 2 cm2 to 8 cm2. In some embodiments, a lump is mobile within an area of 3 cm2 to 6 cm2. In some embodiments, a bulge is mobile within an area of 4 cm2 to 10 cm2. In some embodiments, a bulge is mobile within an area of 5 cm2 to 18 cm2. In some embodiments, a bulge is mobile within an area of 4 cm2 to 12 cm2. Each possibility represents a separate embodiment of the present invention.

In some embodiments, the shoe 10 comprises a support member 12 having a shoe sole-shaped periphery with an upper surface 14. In some embodiments, the shoe 10 comprises an insole placed on top of the upper surface 14. In some embodiments , the insole is the inner bottom of the shoe 10. In some embodiments, the insole sits directly under the foot. In some embodiments, the template is removable, replaceable, or both. In some embodiments, the insole adds comfort, controls shape, moisture, odor, or any combination thereof. In some embodiments, the insole is placed to correct defects in the natural shape of the foot or in the position of the foot during standing or walking. Each possibility represents a separate embodiment of the present invention.

In some embodiments, the peak or ground contact surface of the anterior bulge is positioned laterally from the centerline of the support member. In some embodiments, the peak or ground contact surface of the anterior hump is positioned medially from the centerline of the support member. In some embodiments, the peak or ground contact surface of the anterior boss is positioned laterally from the center line of the support member and the peak or ground contact surface of the posterior boss is aligned with the center line. . In some embodiments, the peak or ground contact surface of the anterior pons is positioned medially from the center line of the support member and the peak or ground contact surface of the posterior pons is aligned with the center line. . Each possibility represents a separate embodiment of the present invention.

In some embodiments, the peak or ground contact surface of the rear boss is positioned laterally from the centerline of the support member. In some embodiments, the peak or ground contact surface of the posterior hump is positioned medially from the centerline of the support member. In some embodiments, the peak or ground contact surface of the anterior boss is positioned laterally from the center line of the support member and the peak or ground contact surface of the posterior boss is aligned with the center line. . In some embodiments, the peak or ground contact surface of the anterior pons is positioned medially from the center line of the support member and the peak or ground contact surface of the posterior pons is aligned with the center line. . Each possibility represents a separate embodiment of the present invention.

In some embodiments, the peak or ground contact surface of the posterior pons is positioned laterally from the center line of the support member and the peak or ground contact surface of the anterior pons is positioned medially from the center line. center of the support member. In some embodiments, the peak or ground contact surface of the anterior pons is positioned laterally from the center line of the support member and the peak or ground contact surface of the posterior pons is positioned medially from the center line. center of the support member. Each possibility represents a separate embodiment of the present invention.

In some embodiments, the protrusions have different heights. In some embodiments, the protrusions have different weights. In some embodiments, a shoe of the invention further comprises a spacer located between the base of a bulge and the support member or sole. In some embodiments, a spacer is used to adjust the height of a protrusion, the weight of a protrusion, or a combination thereof.

In some embodiments, a spacer or protrusion comprises a diameter of 50-150mm. In some embodiments, a spacer or protrusion comprises a diameter of 55-110mm. In some embodiments, a spacer or protrusion comprises a diameter of 60-100mm. In some embodiments, a spacer or protrusion comprises a diameter of 80-90mm. In some embodiments, a spacer or protrusion comprises a diameter of 85mm. In some embodiments, a spacer or protrusion comprises a thickness of 1-12 mm. In some embodiments, a spacer or protrusion comprises a thickness of 1-4 mm. In some embodiments, a spacer or protrusion comprises a thickness of 3-10 mm. In some embodiments, a spacer or protrusion comprises a thickness of 1-3 mm.

In some embodiments, a spacer or nub comprises a hardness of 35-100 Sh A. In some embodiments, a spacer or nub comprises a hardness of 60-70 Shore A, which is a soft spacer. In some embodiments, a spacer or nub comprises a hardness of 90-100 Shore A, which is a hard spacer. In some embodiments, a spacer or nub comprises a hardness of 70-90 Shore A, which is a medium hard spacer. In another embodiment, the nub hardness range as provided herein reflects an effective range that allows for minimal deformation of the nub structure/shape/contour. In another embodiment, the nub hardness range reflects an effective range that eliminates or minimizes rebound. In another embodiment, the hardness range of the protrusion reflects a effective range that nullifies or minimizes the characteristics of the spring. In another embodiment, the nub hardness range reflects an effective range that allows optimal rebound and/or minimizes rebound. In another embodiment, the range of protrusion hardness allows control of the ground reaction force. In another embodiment, the range of protuberance hardness allows control of ground reaction force which is important in treating osteoarthritis. In another embodiment, the nub hardness range allows control of ground reaction force which is important for the treatment of knee pathologies such as knee osteoarthritis. In another embodiment, a hard nub focuses, concentrates and/or potentiates loads exerted on it while a soft nub allows load migration. In another embodiment, a "hard" nub has a Shore hardness in the upper 40% of the Shore hardness range provided in the present description. In another embodiment, a "soft" nub has a Shore hardness in the lower 40% of the Shore hardness range provided in the present disclosure.

In another embodiment, the harder the bump, the more precise the vectorial displacement of the loads exerted by the user on the bump during walking with respect to the [target] body part. In another embodiment, a hard nub minimizes deformation of the nub on impact with the ground, especially in the area that is in contact with the ground. In another embodiment, the softer bulge reduces the impact resulting from contact with the ground. In another embodiment, the soft bulge has better shock absorption properties than the hard bulge and is suitable for the treatment of lower extremity and/or lower back pain.

In another embodiment, a protrusion is a soft protrusion comprising a Shore hardness of between 40 and 55 Sh A. In another embodiment, a protrusion is a medium hard protrusion comprising a Shore hardness of between 50 and 70 Sh A. In another embodiment, a bulge is a hard bulge comprising a Shore hardness of between 65 and 90 Sh A.

In some embodiments, a spacer or protrusion weighs 2-500 g. In some embodiments, a spacer or protrusion weighs 2-250 g. In another embodiment, a spacer or protrusion weighs 2-6 g. In some embodiments, a spacer or protrusion weighs 2-20 g. In some embodiments, a spacer or protrusion weighing between 2-20g is made from Nylon. In some embodiments, a spacer or protrusion weighing between 2-20g is made from Nylon and fiber. In some embodiments, a spacer or bulge weighing between 2-40g is made from Nylon and fiberglass. In some embodiments, a spacer or protrusion weighs 30-100 g. In some embodiments, a spacer or protrusion weighs 50-80 g. In some embodiments, a spacer or protrusion weighs 60-100 g. In some embodiments, a spacer or protrusion comprises: fiberglass, nylon, polyurethane, an alloy (such as, but not limited to, zinc alloy), or any combination thereof. Each possibility represents a separate embodiment of the present invention.

In another embodiment, the ratio of the surface area of the inner sole (the surface that faces the wearer's foot or the surface area adapted to contact the wearer's foot) and the combined surface area of the bases of the insoles. two bulbous protuberances is from 7:1 to 1:0.8. In another embodiment, the ratio of the surface area of the insole to the combined surface area of the bases of the two bulbous nubs is from 5:1 to 1:1. In another embodiment, the ratio of the surface area of the insole to the combined surface area of the bases of the two bulbous nubs is from 4:1 to 1:1. In another embodiment, the ratio of the surface area of the inner sole to the combined surface area of the bases of the two bulbous nubs is from 6:1 to 2:1. In another embodiment, the ratio of the surface area of the insole to the combined surface area of the bases of the two bulbous nubs is from 8:1 to 1:1. In another embodiment, the ratio of the surface area of the insole to the combined surface area of the bases of the two bulbous nubs is from 6:1 to 1:1.5. In another embodiment, the ratio of the surface area of the insole to the combined surface area of the bases of the two bulbous nubs is from 8:1 to 3:1.

In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is from 12:1 to 5:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is from 8:1 to 3:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is from 6:1 to 2:1. According to the invention, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous protrusion of the two bulbous protrusions is less than 12:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is less than 10:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is less than 8:1. In another embodiment, the ratio of the surface area of the insole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is less than 7:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is less than 6:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is less than 5:1. In other embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is less than 4:1.

In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is more than 1:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is more than 1.5:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is more than 2:1. In another embodiment, the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is more than 3:1. In another embodiment, the ratio of the surface area of the outsole (the surface is facing the ground) to the combined surface area of the bases of the two bulbous nubs is from 20:1 to 4:1. In another embodiment, the ratio of the surface area of the outsole to the combined surface area of the bases of the two bulbous nubs is from 1:16 to 1:10. In another embodiment, the ratio of the surface area of the outsole to the combined surface area of the bases of the two bulbous nubs is from 15:1 to 5:1. In another embodiment, the ratio of the surface area of the outsole to the combined surface area of the bases of the two bulbous nubs is from 10:1 to 3:1. In another embodiment, the ratio of the surface area of the outsole to the combined surface area of the bases of the two bulbous nubs is from 8:1 to 1:1. In another embodiment, the ratio of the surface area of the outsole to the combined surface area of the bases of the two bulbous nubs is from 12:1 to 7:1.

In another embodiment, the ratio of the surface area of the outsole (the surface is facing the ground) to the surface area of a base of at least one bulbous nub of the two bulbous nubs is from 40:1 to 18:1. . In another embodiment, the ratio of the surface area of the outsole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is at least 10:1. In another embodiment, the ratio of the surface area of the outsole to the surface area of a base of at least one bulbous nub of the two bulbous nubs is at least 20:1.

In another embodiment, the ratio of the minimum width of the inner sole to the minimum diameter of the base of at least one of the two bulbous projections is from 2:1 to 1:1.5. In another embodiment, the ratio of the minimum width of the inner sole to the minimum diameter of the base of at least one of the two bulbous projections is 1:0.8 to 1:1.2. In another embodiment, the ratio of the minimum insole width to the minimum base diameter of at least one of the two bulbous nubs is at least 1:0.4. In another embodiment, the ratio of the minimum insole width to the minimum base diameter of at least one of the two bulbous nubs is at least 1:0.6. In another embodiment, the ratio of the minimum width of the inner sole to the minimum diameter of the base of at least one of the two bulbous protrusions is less than 1:1.8. In another embodiment, the ratio of the minimum width of the inner sole to the minimum diameter of the base of at least one of the two bulbous protrusions is less than 1:1.5.

In another embodiment, the ratio of the maximum width of the inner sole to the minimum diameter of the base of at least one of the two bulbous protrusions is from 5:1 to 1:1. In another embodiment, the ratio of the maximum width of the inner sole to the minimum diameter of the base of at least one of the two bulbous protrusions is from 4:1 to 1:1. In another embodiment, the ratio of the maximum width of the insole to the minimum diameter of the base of at least one of the two bulbous protrusions is less than 8:1. In another embodiment, the ratio of the maximum width of the inner sole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is less than 6:1. In another embodiment, the ratio of the maximum width of the inner sole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is less than 4:1.

In another embodiment, the ratio of the maximum width of the insole to the maximum diameter of the base of at least one of the two bulbous projections is 2:1 to 1:2. In another embodiment, the ratio of the maximum width of the insole to the maximum diameter of the base of at least one of the two bulbous projections is 1:0.8 to 1:1.2. In another embodiment, the ratio of the maximum width of the inner sole to the maximum diameter of the base of at least one bulbous nub of the two bulbous nubs is at least 1:0.4. In another embodiment, the ratio of the maximum width of the inner sole to the maximum diameter of the base of at least one bulbous nub of the two bulbous nubs is at least 1:0.6. In another embodiment, the ratio of the maximum width of the insole to the maximum diameter of the base of at least one of the two bulbous protrusions is less than 1:1.8. In another embodiment, the ratio of the maximum width of the inner sole to the maximum diameter of the base of at least one of the two bulbous protrusions is less than 1:1.5.

In another embodiment, the ratio of the minimum width of the outsole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is from 2:1 to 1:1.5. In another embodiment, the ratio of the minimum width of the outsole to the minimum diameter of the base of at least one nub bulbosa of the two bulbous protuberances is from 1:0.8 to 1:1.2. In another embodiment, the ratio of the minimum width of the outsole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is at least 1:0.4. In another embodiment, the ratio of the minimum width of the outsole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is at least 1:0.6. In another embodiment, the ratio of the minimum width of the outsole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is less than 1:1.8. In another embodiment, the ratio of the minimum width of the outsole to the minimum diameter of the base of at least one bulbous nub of the two bulbous nubs is less than 1:1.5.

In another embodiment, a base area of a bulge as described herein maximizes support for the wearer's foot. In another embodiment, the combined areas of the bases of the two protrusions allow the two protrusions alone, as described herein, to assist a user.

In some embodiments, a bulge is compressible. In some embodiments, a bump absorbs shock. In some embodiments, a bulge is deformable. In some embodiments, a bulge is compressible or deformable under the pressure exerted by the weight of the subject. Each possibility represents a separate embodiment of the present invention.

In some embodiments, a protrusion is made of a cushioning material. In some embodiments, a bump is made of rubber. In another embodiment, a nub is composed of at least one elastomer. In some embodiments, a bulge is made of an elastic material. In some embodiments, a bulge is made of a continuous elastic material. In some embodiments, a protrusion is made from a "non-Hookean" material. In some embodiments, the elasticity of a bulge is stress dependent. In some embodiments, a protrusion is comprised of a material that is sensitive to temperature and loading rate. In some embodiments, a protrusion is not a spring. In another embodiment, a protrusion is springless. In another embodiment, a protrusion is springless. In another embodiment, a bulge does not have a high elastic limit and therefore cannot return to its original shape after significant bending or twisting. In another embodiment, a protrusion is made of a material that does not exert a force disproportionate to its change in length.

In another embodiment, a bulge has a measurement of less than 10 Young's modulus in GPa. In another embodiment, a bulge has a measurement of less than 7.5 Young's modulus in GPa. In another embodiment, a bulge has a measurement of less than 5 Young's modulus in GPa. In another embodiment, a bulge has a measurement of 0.01 to 7.5 Young's modulus in GPa. In another embodiment, a bulge has a measurement of 0.01 to 5 Young's modulus in GPa.

In another embodiment, a bulge has a density in g/cm 3 of less than 2. In another embodiment, a bulge has a density in g/cm 3 of less than 1.8. In another embodiment, a bulge has a density in g/cm3 of 0.5 to 2. In another embodiment, a bulge has a density in g/cm3 of 0.7 to 1.8. In another embodiment, a bump has a density in g/cm 3 of from 0.7 to 1.5. In another embodiment, a bulge has an elastic limit of 200% (stretched 200% and returned to its original shape). In another embodiment, a bulge has a yield strength of 180%. In another embodiment, a bulge has a yield strength of 150%. In another embodiment, a bulge has a yield strength of 125%.

In some embodiments, a bulge has a convexity defined as follows (see Figure 19): A cross section of the bulge's curvature, from a circumference of the bulge to a vertex of the bulge, can be bounded between graphs of the following two functions :

f(x)=V(8&5x)

f(x)=^(l/3 xA2 )

Reference is now made to Figure 19, which shows a first graph 1000 illustrating function (1) and a second graph 1002 illustrating function (2). The circumference of the bulge is at x, y = 0 for both functions. The vertex of the bump is at x = m for both functions, while the y-axis value of the vertex can be between n1 for function (1) and n2 for function (2). The apex of the bulge is its highest point relative to its circumference. The vertex may be at a horizontal center of curvature or may be offset from that horizontal center. As an alternative to a single point, the vertex can extend over a flat horizontal area. In another embodiment, the cross section of the curvature of the bulge may be continuous or composed of discrete segments. In another embodiment, the bulge may be separated (wholly or partially) into numerous bodies, which are spaced apart horizontally, but whose end surfaces form the aforementioned curvature. That is, if those end surfaces are interpolated to form a continuous line, the portion of that line that extends between the circumference of the protuberance to the vertex of the same would be delimited between the functions (1) and (2).

In another embodiment, at least one protuberance has an abrasion resistance of between 1 and 125 mm3 (according to DIN 53516). In another embodiment, at least one protrusion has an abrasion resistance of between 1 and 20 mm3. In another embodiment, at least one protrusion has an abrasion resistance of between 1 and 60 mm3. In another embodiment, at least one protuberance has an abrasion resistance of between 20 and 110 mm3. In another embodiment, at least one protuberance has an abrasion resistance of between 40 and 80 mm3. In another embodiment, at least one protuberance has an abrasion resistance of between 30 and 60 mm3. In another embodiment, at least one protuberance has an abrasion resistance of between 50 and 120 mm3.

In another embodiment, at least one protrusion has an abrasion resistance of less than 125 mm3 (according to DIN 53516). In another embodiment, at least one protrusion has an abrasion resistance of less than 100 mm3. In another embodiment, at least one protrusion has an abrasion resistance of less than 80 mm3.

In another embodiment, a protrusion comprises a rubber cup. In another embodiment, a bulge comprises natural rubber compounds. In another embodiment, a nub comprises synthetic rubber compounds such as TPU or TPR. In another embodiment, a bump comprises silicone. In another embodiment, a protrusion comprises plastic material such as PA 6 (nylon), PA 6/6 (nylon) fiberglass, ABS, TPU, fiberglass, polypropylene, POM (polyoxymethylene), or any combination thereof. In another embodiment, a protrusion comprises a metal such as aluminum, steel, stainless steel, brass, or metal alloys. In another embodiment, a nub comprises composite materials such as glass fibers, carbon fibers, Kevlar, or any combination thereof. Each possibility represents a separate embodiment of the present invention.

In another embodiment, the basic requirement for continuously balancing a user with the shoe of the invention is achieved when the device comprises two protrusions having a base surface as described, in a columnar order and in offset arrangement. In another embodiment, the bulbous structure of the protrusion along with its Shore hardness, limited deformability, and shock absorption ability are of great importance to the continued balance of a user. In another embodiment, the hardness of the bulge allows for limited deformity/compressibility.

In another embodiment, the limited deformity/compressibility results in less than 20% loss of bulge height at maximum impact (the entire weight of the subject is exerted on the bulge). In another embodiment, the limited deformity/compressibility results in less than 15% loss of bulge height at maximum impact. In another embodiment, the limited deformity/compressibility results in less than 10% bulge height loss at maximum impact. In another embodiment, the limited deformity/compressibility results in less than a 20% increase in the diameter of the bulge (any diameter along the bulge) at maximum impact. In another embodiment, the limited deformity/compressibility results in less than a 15% increase in the diameter of the bulge at maximum impact. In another embodiment, the limited deformity/compressibility results in less than a 12% increase in the diameter of the bulge at maximum impact.

In another embodiment, the basic requirement for the continuous balance of a wearer in the shoe of the invention is achieved when the shoe-device comprises two bulbous protrusions having a base surface as described, in a columnar order, in the offset arrangement, having a Shore hardness as defined herein, having limited deformation capacity, and having shock (energy) absorption capacity (unlike a spring). In another embodiment, the offset arrangement refers to the peak of the protrusions as offset). In another embodiment, not including the base, the protrusion is not in a displaced arrangement/position.

In another embodiment, the phrase "continuous balance of a user" includes constantly inducing a user to stabilize their posture and walk with minimal risk of falling and injury. In another embodiment, the phrase "continuous balancing of a user" includes the development of proprioceptive and/or kinesthetic abilities in a user. In another embodiment, only the two bulbous protrusions can support the user's foot when the two spring elements are placed on a ground surface.

In another embodiment, a shoe of the footwear is in a balanced position, where the balanced position is a position in which the device provides reduced inversion or reduced eversion to the subject's foot during stance phases. In another embodiment, a balanced position is a position in which at least one protrusion is offset from the center line. In another embodiment, a balanced position is a position in which the front boss, rear boss, or both are offset from the center line. In another embodiment, when both the front bulge and the rear bulge are offset from the centerline, each bulge is within or on a different side of the centerline (splitting the outsole/insole in 2). In another embodiment, when both the front bulge and rear bulge are offset from the center line, each bulge peak is within or on a different side of the center line.

In another embodiment, each position described below is characterized in that at least one protrusion is offset from a center line. In another embodiment, each calibration refers to the balanced position as the initial position. In another embodiment, after each calibration, either the front boss, rear boss, or both are offset from the center line.

In another embodiment, the activity of a dorsiflexor is increased by placing the posterior pons 2mm-25mm posteriorly from the equilibrium position. In another embodiment, the activity of a dorsiflexor is increased by placing the posterior pons 5-15 mm posteriorly from the equilibrium position. In another embodiment, the activity of a dorsiflexor is increased by raising the posterior pons. In another embodiment, the activity of a dorsiflexor is increased by raising the posterior pons by 0.5mm-15mm. In another embodiment, raising the posterior hump results in a posterior hump that is 0.5mm-15mm higher than the anterior hump. In another embodiment, the activity of a plantar flexor is increased by placing the posterior pons 2mm-25mm anteriorly from the equilibrium position. In another embodiment, the activity of a plantar flexor is increased by elevating (lifting) the anterior pons. In another embodiment, the activity of an ankle evertor is increased by placing the posterior pons 0.5mm-15mm medially from the equilibrium position. In another embodiment, the activity of an ankle evertor is reduced by placing the posterior pons 0.5mm-25mm laterally from the equilibrium position. In another embodiment, the activity of an ankle dorsiflexor is reduced by elevating (adding at least one spreader) the anterior pons from the neutral position that is the balanced position (the position in which the device provides reduced inversion or reduced eversion). at the foot of the subject).

In another embodiment, the activity of the pes anserine muscles (sartorius semitendinosus and gracilis) is reduced by placing the posterior pons laterally from the neutral position that is the position of balance. In another embodiment, the activity of the quadriceps muscle is increased by placing the posterior pons posterior to the neutral position which is the balance position. In another embodiment, hamstring activity is increased by placing the posterior hump anteriorly from the neutral position which is the balanced position. In another embodiment, the activity of the lateral muscles of the knee (vastus lateralis) is increased by placing the pons posteriorly and medially from the neutral position that is the position of equilibrium. In another embodiment, the activity of the knee flexor muscles (gastrocnemius and hamstrings) is increased by raising the anterior pons. In another embodiment, the activity of a hip external rotator muscle is increased by placing the posterior pons 2-20 mm medially from the equilibrium position. In another embodiment, the activity of a hip extensor muscle is increased by expanding the height of the anterior protuberance from the neutral position that is the position of equilibrium.

In another embodiment, a balanced position is the position in which the shoe exerts the least valgus, varus, dorsal, or plantar torque around the ankle on a subject. In another embodiment, a balanced position is the position in which the shoe provides the least or least muscular activity of the lower extremities. In another embodiment, a balanced position is the position in which the shoe provides balanced muscular activity of the lower extremities. In another modality, a balanced position tones the muscles of the lower extremities. In another embodiment, a balanced position tones the amount of tension or resistance to movement in a muscle involved in walking. In another modality, a balanced position is the offloading of the lower extremity that allows maximum mobility of the ankle, knee, and hip joint. In another embodiment, a balanced position provides reduced muscle activity, increased passive ankle excursion, improved walking ability, or any combination thereof. In another embodiment, a balanced stance increases stride length, stance symmetry, or a combination thereof. In another embodiment, a balanced position increases the length of the point of force action on lower extremity muscles, such as, but not limited to: soleus, tibialis posterior, and both gastrocnemius muscles.

In another modality, bilateral knee osteoarthritis is treated by using bumps with soft hardness or elasticity. In another embodiment, correction of early heel lift in both the right and left legs includes: (1) a 2mm hard spacer is placed between the left posterior PB and the left shoe to bring the left foot into a slight plantar flexion; and (2) a 2mm hard retractor is placed between the right posterior PB and the right brace to bring the right foot into slight plantar flexion.

In another modality, bilateral patello-femoral pain syndrome with slight lateralization of the patella in the left and right knees is treated by using protrusions that have hardness or "hard" elasticity, a 100 g retractor (shape (in order to keep the anterior PB at the same height and not create plantar flexion) and a hard retractor was introduced and a soft spacer between the anterior PB and the shoe under both the left leg and the right leg.

As seen in Figure 2, the posterior boss is generally positioned below a calcaneal (heel, ankle) supporting portion 23 of the support member 12. In some embodiments, the anterior boss may be positioned generally below a metatarsal support portion 25 and/or a phalangeal support portion 27 of the support member 12.

Figure 12 is a simplified pictorial illustration of an alignment of the anterior (forward) and posterior (rearward) bosses on a support member 200, in accordance with embodiments of the present invention.

Centerline 216, in the embodiment shown in Figure 12, is defined as a straight longitudinal (median) line connecting the midpoints of short sides 214 of a rectangle 212, whose long sides 212 are parallel to centerline 216, and delimiting the outline 210 of the support member. In embodiments of the present invention, the contour 210 is the contour (254, see Figure 14) of the footpad confined by the upper part (252, see Figure 14) of the shoe (250, see Figure 14), corresponding to the last which is used to form footwear. In other embodiments of the present invention, contour 210 is the outermost contour of the shoe. In other embodiments of the present invention, the contour 210 is the contour of the lower surface of the sole of the shoe. In accordance with embodiments of the present invention, as shown in Figure 12, the forward boss 218 on the anterior portion (phalanges) of the support member (i.e., its front portion) is positioned medially offset from centerline 216. By "medial displacement" is meant that a peak surface of the bulge 218 (marked with the cross 219) is displaced from the center line 216 medially to the inner side of the bearing surface 200, which faces the bearing member. of the other foot (not shown in this figure). The peak surface is a surface on the protuberance that is farthest from the support surface with respect to other surfaces of the protuberance, and that comes into contact with the ground, when the user fixes the support member to the foot, walks or stands on the ground.

In accordance with embodiments of the present invention, as shown in Figure 12, rear boss 220 on the posterior (calcaneal) portion of the support member (i.e., its rear portion) is positioned laterally offset from centerline 216. By "lateral displacement" is meant that a peak surface of the protrusion 220 (marked with the cross 221) is displaced from the center line 216 laterally towards the outer side of the support surface 200, away from the support member of the other foot. (not shown in this figure).

In some embodiments of the present invention, only the forward bulge 218 is displaced medially, while the rear bulge 220 is substantially aligned with centerline 216. In some embodiments of the present invention, only the rear bulge 220 is displaced medially, while that forward boss 218 is substantially aligned with center line 216.

The alignment of the bumps shown in Figure 12 is useful, for example, for exercisers with one or more of the following medical indications: medial compartment knee osteoarthritis (OA), medical meniscus tear or damage, varus genu, patello-femoral pain syndrome, patello-femoral problem (malalignment), damage or tear of the lateral collateral ligament, bone hematoma or avascular necrosis of the medial tibial plateau or medial femoral condyle MTP/MFC (AVN), low back pain , hip OA, hip labral injury (TMJ), trochanteric bursitis, pes anseninus bursitis, ankle instability (supination and lateral groove), Achilles tendonitis, and metatarsalgia.

Figure 13 is a simplified pictorial illustration of another alignment of anterior and posterior bosses on a support member, in accordance with embodiments of the present invention.

In accordance with embodiments of the present invention, as shown in Figure 13, the forward bulge 218 is offset laterally to centerline 216, while the rear bulge 220 is offset medially to centerline 216.

In some embodiments of the present invention, only the forward bulge 218 is offset laterally, while the rear bulge 220 is substantially aligned with centerline 216. In some embodiments of the present invention, only the rearward (posterior) bulge 220 is laterally offset, while the front (anterior) protrusion 216 is substantially aligned with the center line 216 .

The alignment of the bumps shown in Figure 12 is useful, for example, for exercisers with one or more of the following medical indications: lateral meniscus tear or damage, lateral compartment knee osteoarthritis, valgus knee (genu valgus), patellofemoral pain syndrome, patellofemoral problem (malalignment), medial collateral ligament tear, bone hematoma or avascular necrosis of the lateral tibial plateau or damage or tear of the hip labrum of the lateral femoral condyle, hip pain , ankle instability (pronation), Achilles tendonitis, tibial insufficiency and metatarsalgia.

Figure 14 is a simplified pictorial illustration of an athletic shoe 250 constructed and operative in accordance with one embodiment of the present invention, the rear protrusion 220 of which has a height greater than the height of the front bump 218. It is notable that such an arrangement facilitates initial contact between the rear bump 220 and the supporting ground (not shown in this figure) when a wearer wears the running shoe, before the front bump comes into contact. contact with the ground. When both bumps are placed in contact with the ground, the foot of the wearer wearing the running shoe 250 acquires a downward slope with respect to the wearer's walking direction.

Figure 15 is a simplified pictorial illustration of an athletic shoe 250 constructed and operative in accordance with one embodiment of the present invention, the front bump 218 of which has a height greater than the height of the rear bump 220. In this embodiment, when both bumps are placed in contact with the ground, the foot of the user wearing the sports shoe 250 acquires an upward slope (with respect to the direction of the user's walking).

Figure 16 illustrates the limits of the maximum positioning area of the anterior and posterior protrusions with respect to a support surface, according to embodiments of the present invention. This figure shows a bottom view of a sports shoe designed to be worn on the right foot of a user. The medial side is thus the right side of the drawing, facing the arch of greatest curvature of the side arches of the sneaker. The lateral side is opposite the medial side which is the left side of the drawing, facing the arch of least curvature of the side arches of the sneaker. A grid is provided that divides rectangle 202 into 6*6 sub-rectangles (other divisions may also apply), to help determine the position of the bumps.

Indicated are midsole 401 and tread contour 402 which is determined by the last used in the construction of the athletic shoe, 403 which marks the medial curvature of contour 402. Front rail 404 and rear rail 405 are used to anchor the bump. The area bordered by dotted line 406 marks the maximum area within which the peak surface of the anterior bulge, i.e., the ground contact surface of the anterior bulge, can be located, according to some embodiments of the present invention. In the 6*6 grid, area 406 extends primarily through the second row of subrectangles (counting from the front) and part of the third row of subrectangles. The area bordered by dotted line 407 marks the maximum area within which the peak surface of the posterior hump lies. In the 6*6 grid, area 407 extends primarily through the third and fourth sub-rectangles (adjacent center line 216) of the fifth row (counting from the front) of the grid.

Figure 17 illustrates the limits of the effective area of positioning of the anterior and posterior protrusions with respect to a support surface, according to embodiments of the present invention. Indicated are midsole 501 and outsole 502, tread contour 503 which is determined by the last used in making the running shoe.

The area bordered by the dotted line 504 marks the effective area within which the peak surface of the anterior bulge, i.e., the ground contact surface of the anterior bulge, can be located, according to some embodiments of the present invention. In the 6*6 grid, area 504 extends primarily along four sub-rectangles, two on each side of center line 216, the second row of sub-rectangles (counting from the front) and part of the third row of sub-rectangles. subrectangles.

The area bordered by dotted line 505 marks the effective area within which the peak surface of the posterior hump lies. "Effective" refers to the efficacy of wearing the shoe in accordance with embodiments of the present invention, facilitating noticeable and useful proprioceptive/kinesthetic training. In the 6*6 grid, area 505 extends primarily across the third and fourth sub-rectangles (adjacent center line 216) of the fifth row (counting from the front) of the grid.

It is noted that the term "bulbos" is taken in the broadest sense to also include a cut bulbous protuberance, a truncated bulbous protuberance, a cropped bulbous protuberance. If trimmed or trimmed, the trimmed or trimmed portion serves as the ground contact of the bump, the base surface, or both (eg, both sides are trimmed or trimmed).

Figure 18A is an isometric view of a bulge suitable for use in a shoe, according to embodiments of the present invention. Cleats 901 are provided on the surface of the bump to facilitate better gripping of the surface on which the user stands or walks. In some embodiments, the tines or gripping means are constructed of any suitable material, such as, but not limited to: elastomers such as rubbers or plastic materials. In some embodiments, the spikes or gripping means cover only part of a protrusion. In some embodiments, the spikes or gripping means cover at least one ground contact surface of a protrusion (the surface in contact with the ground during stance). In some embodiments, an attachment means for securing a protrusion to the support portion is embedded within a barb or grip means. In some embodiments, an attachment means for securing a protrusion to the support portion is placed between barbs or gripping means. Each possibility represents a separate embodiment of the present invention.

Figure 18B is a front view of a bulge suitable for use in a shoe, according to embodiments of the present invention. The beak surface is marked with a cross 902. A hole 904 is provided for a screw or other fastening arrangement to fix the boss in the desired position.

Figure 18C is a side view of a bulge suitable for use in a shoe, according to embodiments of the present invention. The convexity 905 of the bulge is clearly seen. Various convexities may be employed, all of which define a peak surface, typically (but not necessarily) in the center of the bulge, which is the surface that comes into contact with the ground when the user attaches the support member to the foot, and walk or stand on the ground.

Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above. Instead, the scope of the present invention is defined by the appended claims.

examples

Example 1: Treatment of bilateral knee osteoarthritis (medial compartment, genu varus) with a device of the invention

A 68-year-old patient presented to the clinic with a significant symptom of bilateral knee OA.

History: The patient complained of bilateral knee pain, mainly in the left knee, which lasted for 5 years before the visit. The patient experienced a gradual increase and decrease in pain with function (walking, going up and down stairs). The degree of pain when walking was 6/10 (on a 10 cm visual analog scale, a higher value means more severe). The patient suffered from moderate stiffness in the morning hours and severe difficulty getting out of cars.

Physical exam: The thigh muscles were atrophied. The knees were varus aligned with limited knee extension on both sides (Left: -10°, Right: -5°). Palpation was characterized by tenderness in the medial joint line in the left knee and in the pes anserine region in the left knee. The right knee was also characterized by tenderness, as well as the medial joint line and pes anserine region were also characterized by tenderness. During walking, the patient experienced medial joint line pain in both knees at heel strike (VAS 5/10 in the left knee and 3/10 in the right knee). The patient also experienced pain in the pes anserine region in the intermediate stance phase through toe-off phase.

Imaging and Laboratory: Standing knee radiograph: Anteroposterior view reveals joint space narrowing in the medial compartment and osteophytes, Kellgren & Lawrence classification 3 in both knees. The results of the gait laboratory (see table 1) showed a speed of 93 cm/s, single limb support of 37.0% in the left leg and 38.1% in the right knee. Step length: Left: 61 cm Right: 60 cm.

Table 1: Patient gait parameters

Treatment

Bulbous bumps (PB with the lowest convexity (A) and hardness or soft elasticity were placed under the hindfoot and forefoot.

Balance: Patient visually balanced by reducing eversion and inversion through heel strike, mid-stance, and toe-off.

Pain: To reduce pain in the medial right knee joint line at right posterior heel strike PB was displaced 1-2mm laterally and fixed. The patient was then asked to walk 20 m with the device and reported a 5/10 to 3/10 reduction in pain. The right posterior element was displaced 1-2 mm more laterally. The patient reported that the pain disappeared in the right medial joint line while walking with the device.

To reduce pain in the right pes anserine, the right anterior PB was displaced 1-2 mm medially. At this point, the patient reported no further pain in the region of the right pes anserine while walking with the device.

In order to reduce pain in the medial left knee joint line at heel strike, the left posterior PB was displaced 1-2 mm laterally. The patient reported a reduction in pain on walking from 5/10 to 3/10 when using the device. After the left posterior PB was displaced 1-2 mm laterally, the patient reported a further reduction in pain to 2/10 at the medial left knee joint line while walking with the device. Further lateral displacement of the left posterior PB increased eversion at heel strike in the left leg, making the patient unbalanced. Therefore, the left posterior PB moved back to the last position (where the pain was 2/10 when walking).

To reduce pain in the left pes anserine, the left anterior PB was displaced 1-2 mm medially. At this point, the patient reported reduced pain in the left pes anserine region while walking with the device. After the left anterior PB moved 1-2 mm more medially, the pain disappeared in the left pes anserine region when walking with the device.

Heel lift moment: The patient was asked to walk 20 m to confirm that he was still balanced and that the heel lift moment was adequate. It was noted that the patient presented early heel elevation in both the right and left legs. At this stage a 2mm hard spacer was placed between the left posterior PB and the left shoe to bring the left foot into slight plantar flexion. This time the heel rise time was just right on the left leg. At this stage, a 2-mm hard spacer was placed between the right posterior PB and the right device to bring the right foot into slight plantar flexion. This time, the heel lift time was adequate on both the right and left legs.

Prescription: At week 1, the patient received safety instructions and was asked to wear the device at home for 45 minutes a day (and cumulatively walk about 5 minutes a day as part of their daily activities at home) . The patient was instructed to increase the time of daily device use by 5 minutes each week for the first 6 weeks, reaching 75 minutes of device use every day (12-15 minutes of cumulative walking). The patient was monitored at the treatment center 6 weeks after his first visit, 3 months after his first visit, and 6 months after his first visit.

Treatment: The patient immediately reported a reduction in pain when walking with the device; the patient gradually reported a decrease in pain also when walking without the device. At follow-up visits, gait speed was increased to 110 cm/s, an increase in step length of 65.5 cm in the left leg and 65.0 cm in the right leg was observed. Single-limb support bilaterally increased to 38.0% in the left leg and 38.6% in the right leg, the patient had a smaller difference between single-limb support of the right and left leg ( a more symmetrical gait). After 10 weeks of treatment, the patient reported that his pain was substantially reduced when walking without the device and he found it much easier to stand for prolonged periods. The patient gradually increased daily use of the device, up to daily use of up to 3 hours per day. After 3 months, the patient was also allowed to walk outdoors with the device. After the first 6 months, the patient continued with follow-up visits two to three times a year.

Example 2: Treatment of a patellofemoral pain syndrome (hypermobility and genu valgus) with a device of the invention

A 30-year-old female patient who came to the consultation with a diagnosis of patellofemoral pain syndrome. History: Patient complaining of bilateral knee pain for the past 5 years. The left knee hurt more than the right. During the last 6 months there was an exacerbation in the level of pain to a level of approx. 5/10 on a visual analogue scale (exacerbation appeared after an intensive day of house cleaning). She reported experiencing anterior knee pain while sitting with her knees bent for more than 20 minutes (viewers knee). The patient who was an amateur dancer and stopped dancing because the pain intensified. The patient reported being extra flexible since childhood.

Physical examination: the patient had valgus alignment and recurvatum in both knees. On palpation, tenderness was noted on the medial aspect of the patella. The patellar compression test was positive. Examining the progress of the patient, the patient reported that the pain is on the medial side of the patella while walking, the pain appeared at heel strike and is greater in the left knee compared to the right knee, 5/10 and 3/10, respectively .

Imaging/gait: X-ray of the knees showed a slight lateralization of the patellas in the left and right knees. Gait lab results showed a speed of 110 cm/s, single-limb support of 41.8% on the right leg and 42.4% on the left knee. Step length: Left: 57 cm Right: 58 cm.

Treatment: Identical BPs with B convexity and "hard" hardness or resiliency were placed under the hindfoot and forefoot on the left and right leg. A 100g (disk-shaped) 3mm spacer was introduced between the sole and the posterior PB under the left leg and the right leg and (to keep the anterior PBs at the same height and not create plantar flexion) a hard retractor and a soft retractor was inserted between the anterior PB and the shoe, both under the left leg and the right leg.

Balance: Patient balanced visually, reducing eversion and inversion through heel strike, mid-stance, and toe-off.

Pain: To reduce right patella pain on heel strike, the posterior PB was moved 3 mm anteriorly and 2 mm medially below the right leg. The patient then reported no pain in his right knee while walking with the device. To reduce pain in the left patella on heel strike, the posterior PB was displaced 3 mm anteriorly and 2 mm medially below the left leg. The patient then reported that he felt a 70% decrease in pain on the medial side of the patella in his left knee while walking with the device. At this point, the posterior PB of the left foot moved 1 mm further forward. The patient reported that walking with the current configuration of the device left him with only very mild pain (1-2/10) on the medial side of the left patella.

Heel lift moment: The patient was asked to walk 20 m to confirm that he is still balanced and that the heel lift moment is adequate. The patient was noted to have delayed heel raise on both the right and left foot. At this stage a 2mm hard spacer was placed between the left anterior PB and the left shoe to bring the left foot into slight dorsiflexion. The patient was observed to walk with the device; the heel lift time was adequate on the left foot. At this stage, a 2-mm hard spacer was placed between the right anterior PB and the right shoe to bring the right foot into slight dorsiflexion. The patient was observed to walk with the device; the heel lift time was now correct on the right leg.

Prescription: The patient was briefed with safety instructions and at week 1 was asked to wear the device at home for 45 minutes a day (and to cumulatively walk about 5 minutes a day as part of their daily activities at home). ). The patient was instructed to increase daily device-wearing time by 5 minutes each week for the initial 4 weeks, reaching device-wearing time of 60 minutes daily (cumulatively walking or standing from 7 to 10 minutes a day). The patient was monitored at the treatment center 4 weeks after his first visit, 10 weeks after his first visit, and 5 months after his first visit.

Course of Treatment: Patient immediately reported reduced pain when walking with the device; the patient reported a gradual decrease in pain also when walking without the device to a level of 2/10 after 3 months. He was now able to sit for long periods of time without pain and walked without pain without the device. At follow-up visits, an increase in stride length bilaterally, a decrease in stride length difference, a decrease in single limb support bilaterally (towards 40%), and a decrease in limb support difference a single limb (see Table 2 for gait parameters) were observed. The patient gradually increased daily use of the device, reaching daily use of 2 hours after 5 months (cumulative walking of 20 minutes per day). After 5 months, the patient reached 23 follow-ups each year.

Table 2: Patient gait parameters

Example 3: Treatment of a degenerative tear of the medial meniscus (radial tear in the posterior horn of the medial meniscus) with a device of the invention

A 57-year-old patient who comes to the clinic with an important symptom of left medial meniscus tear. History: Patient suffered from occasional knee pain for the past 6 years with symptoms alternating between left and right knee. Four weeks before his arrival at the clinic, he had an event of acute pain in his left knee while walking in the afternoon. He ruled out any trauma to the knee.

On admission, his left knee pain is 6/10 (on a 10-cm visual analog scale) in the medial joint line. The patient reports that he experienced great pain while walking and was unable to fully extend the knee.

Physical examination: On inspection, the knees are in varus alignment. The left knee is slightly flexed when standing, and mild atrophy of the VMO muscle is evident. The patient had limited left knee extension of: 10°. There was tenderness in the medial joint line of the left knee, and the McMurray test for the left medial meniscus was positive. The patient did not fully extend the left leg when walking. The patient reported pain in the medial joint line of the left knee at heel strike.

Imaging and Laboratory: Standing knee radiograph: Anteroposterior view showed mild medial compartment changes bilaterally. Magnetic resonance imaging revealed a radial tear of the posterior horn of the left medial meniscus. The results of the gait laboratory (see table 3) showed a speed of 85 cm/s, single limb support of 35.6% on the left leg and 39.5% on the right leg. Step length: Left: 60 cm Right: 58 cm.

Table 3: Patient gait parameters

Therapy: Identical PBs with convexity B were fixed under the hindfoot and forefoot of the patient's right foot. The PBs had a "soft" hardness. Under the left foot two PB with convexity C (which is higher than B) were placed under the rearfoot and forefoot. PBs under the left foot had a higher convexity to introduce more disturbance/instability under the left foot, which presumably promoted more coordinated recruitment of muscles and reduced left knee muscle protection. The increased convexity under the left foot also provided additional height compared to with the right foot, thus promoting "offloading" (a shift of body weight from the affected left leg to the right leg).

Balance: Patient balanced by visually reducing eversion and inversion through heel strike, mid-stance, and toe-off.

Pain: To reduce pain in the medial left knee joint line at heel strike, the left posterior PB was displaced 1-2 mm laterally. The patient reported that his left medial joint line pain was reduced while walking with the device from 6/10 to 4/10. At this point, the left posterior PB moved 1-2 mm more laterally. The patient reported that the pain was further reduced to 2/10. The left posterior PB was displaced 1-2 mm more laterally. After the last lateral shift it was observed that on heel strike the patient increased in eversion and thus the left posterior PB was fixed back in the anterior position (where the pain was 2/10).

Heel lift moment: The patient was asked to walk 20 m to confirm that he is still balanced and that the heel lift moment is adequate. An early heel lift was noted on the left leg. A 2-mm soft spacer was inserted between the left posterior PB and the device. Once the patient walked with the device, the heel rise time for the left leg was corrected. In this case, the spacer was a soft spacer to reduce the impact at heel strike.

Prescription: The patient was briefed with safety instructions and asked to use the device at home for 45 minutes a day in week 1 (and cumulatively walk about 5 minutes a day as part of their daily activities at home). ). The patient was instructed to increase daily device wearing time by 5 minutes each week for the initial 3 weeks, reaching 60 minutes wearing time with the device every day (8-10 cumulative minutes of walking or standing). foot). The patient was monitored at the treatment center 3 weeks after his first visit, 6 weeks after his first visit, and 3 months after his first visit.

Treatment: The patient immediately reported a reduction in pain when walking with the device; the patient gradually reported a decrease in pain also when walking without the device. After 3 months of treatment, the pain in the left knee was reduced to 2/10. Gait speed was increased (see Table 3), an increase in left and right leg step length was observed, and single-limb support was increased on both the left and right legs. The patient had a smaller difference between the single-limb support of the right and left leg (a more symmetrical gait). The patient reported increasing pain relief when walking in street shoes or barefoot. Clinical visual gait assessment showed full extension of the left knee during stance phase. Once pain was reduced, full extension was achieved, and single-limb stance symmetry improved, the different calibrations in the right and left systems were matched. The patient had PB "C" under the hindfoot and forefoot of both legs. The additional soft spacer was removed from under the left posterior PB

The patient gradually increased daily use of the device, up to daily use of up to 2 hours per day. After 3 months, the patient was also allowed to walk outdoors with the device. After the first 6 months, the patient came to the center 2-3 times a year for follow-up visits. The additional spacer that was introduced between the left posterior PB and the shoe was removed after the difference in single-limb support was reduced below 2%.

Example 3: Tear of the left anterior cruciate ligament (without pain) with a device of the invention

A 27-year-old patient presented to the clinic with a significant complaint of a left anterior cruciate ligament (ACL) tear.

Anamnesis: 2 months before arriving at the clinic, the patient sprained his left knee in a soccer game. After this event, the knee swelled and hurt. The patient was treated in a physical therapy clinic since the injury and was pain-free, but had experienced twice-weekly "giving way" events in his left knee. He was also unable to enjoy activities such as soccer, running, or jumping.

Physical examination: On observation, the knees were varus aligned. The anterior drawer test was positive in the left knee. The McMurry and valgus stress tests were negative. Imaging and lab: MRI revealed that there is a tear in the left ACL. The results of the gait laboratory (see table 4) showed a speed of 110 cm/s, single limb support of 38.2% on the left leg and 40.5% on the right leg. Step length: Left: 63 cm Right: 62 cm.

Table 4: Parameters of the patient's gait

Therapy: Identical PBs with B convexity and "hard" hardness were attached under the hindfoot and forefoot of the patient's right foot and patient's left foot. A 2mm 100g weighted retractor (disk) was inserted between the shoe and the posterior PB under the left and right foot and (to keep the anterior PBs at the same height and prevent plantar flexion) a retractor was inserted soft between the anterior PB and the sole under both the left foot and the right foot. The weighted spreader was introduced to induce increased activity in the muscles of the left leg and right leg. It was planned to increase the convexity of the Pb as the treatment progressed.

Balance: Patient balanced by visually reducing eversion and inversion through heel strike, mid-stance, and toe-off.

Pain: the patient had no pain and was calibrated according to the balance criteria.

Heel lift moment: The patient was asked to walk 20 m to confirm that he is still balanced and that the heel lift moment is adequate. The heel lift was correct.

Prescription: Patient was now briefed with safety instructions and at week 1 was asked to wear the device at home for 1 hour per day (and cumulatively walk 10-15 minutes per day as part of their daily activities In the home). The patient was instructed to increase the time of daily device use by 10-15 minutes each week for the initial 3 weeks, reaching 90 minutes of device use daily (approximately cumulative walking minutes per day). The patient was monitored at the treatment center 3 weeks after his first visit, 6 weeks after his first visit, and 3 months after his first visit.

Course of treatment: the patient reported a significant reduction in the "shapes of yielding" already after 3 weeks of treatment, the speed of walking in the laboratory was higher; step length and single-limb support were increased at the left and right knee. At the first follow-up meeting, the PB convexity increased to "C" under the hindfoot and forefoot on both the left and right legs. After 6 weeks of treatment, the patient was also given the designated exercise to incorporate with the device. After 3 months of treatment, the patient returned to playing soccer as an amateur. The convexity of the 4 PBs gradually increased. The daily use of the device was increased until reaching up to 3 hours per day of use both indoors and outdoors.

Example 4: Hip osteoarthritis

A 72-year-old patient presented with pain, difficulty walking, difficulty climbing stairs, and difficulty standing for long periods of time.

The patient reported having pain in the area of the right greater trochanter and the inguinal area. The pain was felt when walking, getting up from a sitting position, and when climbing stairs. The patient had the pain for the past year and reported that it gradually worsened. He also described stiffness around his right hip area after getting up in the morning for 15 minutes.

Physical examination: On observation, the patient's knees are in a slight valgus alignment and she is standing with an anterior pelvic tilt (right hip flexion deformity). Internal rotation of the right hip in the neutral position was complete but painful at the end of the range. Internal rotation of the right hip in 90 degrees of flexion was 15 degrees and painful (30 degrees in the left hip). The FADIR test was positive on the right and negative on the left. Right hip extension showed limited range of motion compared to the left (10 degrees and 25 degrees, respectively). The clinical evaluation of Gait revealed increased posterior rotation of the pelvis to the right during late stance. The patient reported that she feels groin pain both during heel strike and late stance. She rated the pain as 4/10 on VAS.

Gait and Imaging Laboratory: Supine radiographs revealed narrowing of the right hip joint space with subchondral bone sclerosis and subchondral bone cysts. The left hip showed less joint space narrowing. Gait lab data provided: gait speed 91 cm/s, right stride length 55 cm, left stride length 52.3 cm, right limb support only 37.3%, and right limb support only left 39.1%. The in/out toe angle of the foot was -3.1 degrees to the right (indicating 3.1 degrees toe in) and 5 degrees to the left (indicating 5 degrees toe out) (see table 5 for gait lab data).

Table no. 5: Patient gait parameters

Course of treatment: PB with convexity B (medium) and resilience/hardness "soft" were connected and fixed under the rear foot and forefoot of the left and right shoe. A 100 g spacer (disk-shaped) of 3 mm height was placed and fixed between the sole and the posterior bulge under both legs. In order to keep the anterior protuberance at the same height so as not to create a plantar flexed position, a hard retractor and a soft retractor were introduced and fixed between the anterior protuberance and the shoe, both below the legs.

Balance: The patient's device was calibrated and fine-tuned during repeated clinical evaluations of gait with the device (shoes). During this process, care is taken to reduce eversion and inversion during heel strike, load response, mid-stance, and toe-off.

Pain: To reduce pain in the right groin during heel strike, the right posterior PB was calibrated 3 mm posterior and 2 mm medial. The patient reported that the pain was reduced to 2/10 (from a level of 4/10). To further reduce pain, the right posterior PB was calibrated and fixed in a new position (1 mm posterior and 1 mm medial). The patient reported that the pain during heel strike was reduced to mild discomfort. However, the foot appeared to invert during heel strike, so the right posterior PB was calibrated and set 1 mm lateral to its anterior position. As a result, the pain was reduced to a level of 1/10 while walking with the system. The left system was balanced and recalibrated to minimize eversion and inversion in all phases of the posture.

Synchronization of heel raise: The patient was asked to walk 20 meters to see if the heel raise was synchronized in the gait cycle. The patient was noted to have delayed heel elevation in both the right and left legs. To correct this, another 2mm hard spacer was affixed between the right anterior PB and the right boot, thus placing the right ankle in a more plantar flexed position. The patient's gait was reassessed and the heel lift seen on the right normalized. The patient reported at this point that she felt a significant decrease in pain during late posture (0.5 on VAS). This is presumably because the created dorsiflexion reduced the need for hip extension in this phase of gait. Thus, the patient was better supported by the shoe. To correct the timing of the left heel lift, another 2 mm hard spacer was affixed between the left anterior PB and the left boot, thus bringing the left ankle into a more plantar flexed position. The patient's gait was reassessed: the elevation of the left heel was normalized.

Treatment plan: the patient was informed about the safety instructions of the device and was instructed to start treatment with a total wearing time of 30 minutes per day during the first week of treatment (cumulative weight loading time was defined as 15 % of total usage time, i.e. 5 minutes). She was asked to increase her total time wearing the device by 10 minutes per week for the first 6 weeks of treatment, maintaining the relative 10% cumulative weight-bearing time. The patient was seen for follow-up visits 6 weeks after the initial consultation, 3 months after the initial consultation, and 5 months after the initial consultation.

Treatment Progression: As described above during the initial consultation, the patient experienced an immediate reduction in pain while walking with the calibrated device. At the first follow-up visit, the patient reported that she found housework much easier than before and less painful. Results from the gait monitoring lab indicated an increase in speed, stride length, and sole support in both legs, as well as improvement in gait symmetry. The patient was asked to continue increasing total wear time at a rate of 15 minutes per week while increasing cumulative weight bearing time to 15% of total wear time.

At the second follow-up, the patient reported that morning stiffness was substantially reduced and she found walking outdoors without the device easier. He reported that he currently feels pain around the greater trochanter when walking for more than 45 minutes (VAS 1-2/10). Pain in the groin area was very rare. By this time, the patient was wearing the device for 4 hours a day and was functioning freely indoors (gait lab data provided in Table #5). The posterior PBs on both devices were changed to C-convexity (more convex) to provide a greater challenge for his neuromuscular system. Since the convexity C bumps are higher than the convexity B bumps (which remained unchanged in the previous bump in both the left foot device and the right foot device) a hard spacer was introduced between the sole and the upper. base of anterior bump on right and left boots. This was done without changing the location of the previous bumps. After this calibration, the patient's gait was reassessed, including the balanced calibration (as explained above). The patient reported no pain or discomfort with the new calibration. He was instructed to maintain the full treatment time.

After the first 5 months, the patient was seen twice a year for follow-up visits and monitoring. His ability to walk and his pain improved dramatically.

Example 5: Left Total Knee Replacement and Right Knee OA

A 71-year-old man presented to the treatment center 3 months after undergoing total left knee arthroplasty.

Case History: Patient had left knee OA for 5 years before undergoing elective TKR. He suffered from medial and anterior right knee pain for the past 2 years. The patient reported that he received physical therapy for 3 months after surgery, but feels weak in his injured leg. He also reported an increase in medial right knee pain since surgery which he rated as 6/10 at worst.

Physical examination: On observation, the patient bears more weight on the right leg, the quadriceps and triceps surae on the left are atrophied compared to the right. Supine range of motion testing revealed full extension of the right and left knees. Flexion to the right was 110 degrees and to the left 120 with left medial knee pain occurring at the end of the range. Palpation did not produce any pain in the left knee and produced tenderness in the medial joint line of the right knee. During clinical gait evaluation, the left knee was noted to have inadequate flexion during the swing phase, which resulted in circumduction of the hip as compensation. During the stance phase, the left knee was not fully extended and remained at about 10 degrees of flexion. The patient reported medial knee pain in the left knee that was felt primarily during heel strike and weight-bearing phases. He rated that pain as 4/10 on EVA.

Imaging and gait lab: supine x-rays (unfortunately standing x-rays were not available at initial consultation) showed that the TKR prosthesis was well placed and did not show any signs of infection or loosening. Radiographs of the left knee revealed mild-moderate narrowing of the medial joint space. Kellgern-Lawrence scoring was impossible as the X-rays were performed in the supine position. Gait lab data revealed: a walking speed of 68 cm/s, left limb support only 32.3%, right limb support only 37.2%, left step length 51.1 cm and right step length 46.5 cm (see Table 6 for detailed gait lab data).

Table 6: Patient Gait Parameters

Therapy: PB with convexity B and "soft" elasticity were placed and fixed under the hindfoot and forefoot of the left device. PB with C convexity and "soft" elasticity were placed and attached under the rearfoot and forefoot of the right foot. Since the C-convexity PBs are higher than the B-convexity bulges, and since gait lab data showed that the patient has reduced single-limb support on the left leg, 3 hard retractors were inserted and they were fixed under the anterior and posterior PB of the left foot. This calibration, called "offloading," induces easier swinging of the contralateral leg by increasing the height of the BPs on the affected leg. In this case, the left leg is 3 mm higher than the right leg.

To increase proprioceptive input, a 100-g disk was inserted between the shoe and the posterior PB of the left and right systems. This brought both ankles into a slightly plantar flexed position. This was not corrected as the left knee failed to reach full extension during the stance, it is supported by plantar flexion.

Balance: The patient's system was calibrated and fine-tuned during repeated clinical evaluations of gait with the device. During this process, care is taken to reduce eversion and inversion during heel strike, load response, mid-stance, and toe-off.

Pain: To reduce pain in the right medial knee, the posterior PB of the right system was calibrated 2 mm laterally and fixed in the new position. The patient then reported that his pain was reduced to 3/10 while walking with the device. Therefore, the posterior pons of the right system was calibrated an additional 2 mm laterally and fixed in the new position. When the patient returned to walking with the device, the pain was reduced to 1/10. The posterior bulge of the right device was calibrated and set 1 mm more laterally, but clinical gait assessment showed that the right foot was now excessively pronated and the patient reported no further decrease in pain. Therefore, the posterior PB of the right system was recalibrated to its previous position and fixed there. Clinical gait assessment showed that right foot eversion was now to an acceptable amount and the patient rated medial knee pain as 1/10.

To improve left knee extension during stance, the posterior PB of the left shoe anterior to its neutral position was calibrated and set 5 mm. The knee appeared to be more extended during the stance phase and walking speed increased. The patient reported that walking with shoes is much more comfortable than walking with normal sneakers.

Timing of heel raise: The patient was asked to walk 20 m to confirm that he was still balanced and that the heel raise was well synchronized in the gait cycle. Clinical gait evaluation showed an early heel lift on the left leg. To correct this, a hard retractor was introduced and fixed under the posterior PB in the left shoe. Repeated gait testing showed that the left heel lift had normalized.

Repeat gait lab test: Once the balance process was complete, the patient performed another gait lab test with the device. The results of this test were significantly better than the initial results. Gait speed increased to 80 cm/s, left single limb stance 35.1%, right single limb stance 36.2%, left step length 55.2 cm, and right step length was 49.5 cm (see Table 6 for detailed data on the gait lab). The data of this test showed that the speed of the march was 74.2 cm/s, support only in the left extremity of 33.8%, support only in the right extremity 36.9%, length of the left step 55, 0 cm and the right step length was 48.1 cm (see Table 6 for detailed data on the gait laboratory). These results show that the patient's gait is greatly improved by the device and that some of the improved motor control (eg, improved left knee extension during stance) is preserved for at least a short period of time.

Treatment plan: The patient was briefed with safety instructions and instructed to begin treatment using the device for one and a half hours a day for the first week of treatment. Cumulative weight-bearing time was set at 10% of the total shoe-wearing time. Thus, the hour and a half was supposed to bear weight for a cumulative period of 9 to 10 minutes. The patient was asked to increase total shoe-wearing time by 15 minutes in the second week, maintaining the relative 10% of cumulative weight-bearing time. The patient was seen for follow-up consultations 2 weeks after the initial consultation, 6 weeks after the initial consultation, 3 months, and again 6 months after the initial consultation.

Treatment Progression: As mentioned above, the patient had immediate pain relief in his right knee and had better knee extension in his left when walking in shoes during the initial consultation. During the second follow-up visit, the patient reported that he enjoyed walking in the shoe and found it easier and less painful to walk and function in it. The pain in the right knee was not constant now, although its maximum level did not decrease (VAS 6/10). Gait lab testing revealed an increase in left single limb support (from 32.3% to 33.9%) and an increase in right step length (from 46.5 cm to 47.3 cm). , for the details of the gait laboratory, see table no. 6). Due to the improvement and due to the fact that the differences between right and left single limb support and step length were still significant, the calibration of the right and left boots remained unchanged. The patient was asked to increase total shoe use by 15 minutes per week. In addition, he was instructed to walk continuously with the device indoors, starting with 2 minutes of continuous walking and increasing by 2 minutes each week.

At second follow-up, the patient reported achieving 2.5 hours of total wear time, of which he had a cumulative weight-bearing time of 15 to 20 minutes. In addition, he reported much less pain in his right knee while performing daily activities without the shoe on (VAS 3/10). Gait lab data revealed additional increases in gait speed (79.3 cm/s), left single-limb stance (35.8%), and right and left step length (56.3 cm and 58.1 cm respectively). These results represent a marked improvement in gait symmetry and reflect patient reporting of improvement in pain level and functional level. Therefore, the calibration was changed to C-convexity in the anterior and posterior PBs of the left device. The hard spacer on the posterior bulge of the left device was removed as barefoot walking knee extension was now complete. The calibration on the right device remained unchanged. The patients' gait was reassessed with the device and no gait deviations were observed. The patient reported that he was comfortable walking with the new calibration and did not experience any symptoms. A shoe gait lab test was performed which showed encouraging results, as was a barefoot gait lab test repeat (see detailed results in Table 6). The patient was asked not to increase the wearing time to allow a customization process to take place. He was told to gradually increase the total wear time to 4 hours and increase the cumulative weight-bearing time to 15% of the total wear time. In addition, he was instructed to gradually increase his indoor walking to 15 minutes.

The patient continued to have gait improvement and pain relief. At the third follow-up visit, he was allowed to take walks outdoors with the device. The results of the gait lab are shown in Table 6. The patient was seen again for a follow-up visit 6 months after the initial visits in which he reported no pain or weakness in his left leg and only occasional mild pain. (1-2/10) on the medial aspect of the right knee. After this, the patient was asked for follow-up visits twice a year.

Example 6: Posterior Left Total Hip Replacement

A 75-year-old man presents to the treatment center 3 weeks after elective right total hip replacement.

Case History: The patient had had left hip pain for four years prior to surgery, with a significant increase in pain and functional limitations during the year prior to surgery. During surgery, a cemented total hip prosthesis was placed. He was told to put his full weight on his operated leg, but he was unable to do so because of the pain and fear that he would not support it. At the time he was first seen, he was wandering around with a walker and was limited to walking alone indoors. Pain was felt around the surgical wound and deep in the groin area (VAS 5/10).

Physical exam: On observation, standing, the patient bears significantly more weight on the right leg and is positioned in forward flexion of the trunk. The ranges of movement measured in the supine position were: hip flexion - left: 80 degrees, right: 105 degrees. Internal rotation in neutral position - left: 15 degrees, right: 25 degrees. During the clinical gait evaluation, the patient had great difficulty walking without the walker, thus the evaluation was minimal. The patient rated the pain as 5/10 on VAS and described the left leg as very weak.

Imaging and gait lab: X-rays showed that the prosthesis was in good position with no signs of loosening or infection. The right hip showed mild joint space narrowing. Gait lab results showed that gait speed was 37 cm/s, left step length: 21 cm, right step length: 25 cm, left limb support only: 19.0%, support only in the right extremity: 42.1%.

Therapy: PB with a convexity level A (low level) were placed and fixed under the hindfoot and forefoot of the left device. PB with level C (high level) of convexity were placed and fixed under the hindfoot and forefoot of the right device. A 100-g spacer (disc) was inserted and fixed between the sole and posterior PB of the left and right shoe to increase proprioceptive input during swing and improve pelvic muscle control during stance. To support the patient in the forward flexed position (and correct the plantar flexed position created by disc insertion in the posterior PBs) 2 hard retractors and one soft retractor were inserted and affixed between the shoe and the anterior PBs in the device. left and right. Since convexity C provides a higher height than convexity A, balance was required. Due to the large difference in single-limb support between the left and right legs, it was necessary to "unload" the left leg (for details on the rationale for unloading, see the examples above). For this, 2 hard spacers were inserted between the sole and the anterior protuberance of the left boot. Two additional hard spacers were inserted between the sole and the base of the anterior PB of the left device.

Balance: The patient's footwear was calibrated and fine-tuned during repeated clinical evaluations of gait with the device. During this process, care is taken to reduce eversion and inversion during heel strike, load response, mid-stance, and toe-off.

Pain: To decrease pain in the left hip during weight bearing, the left posterior shoe bump was calibrated and set 6 mm posteriorly and 4 mm medially to its anterior position. The patient reported that the pain decreased to a level of 4/10 on the VAS and found that the leg is now more weight bearing. The left posterior PB was calibrated and set 2 mm more posteriorly and 2 mm medially, and the patient reported another decrease in pain level (3/10) and weight-bearing comfort. During clinical gait evaluation, it became clear that gait speed had increased and weight bearing was performed on the left leg with more movement in hip extension. This process continued until the left posterior PB was fixed 15 mm posteriorly and 8 mm medially to its original position. The patient had a marked improvement in pain (VAS 2/10) and gait symmetry. The same process was repeated with the right device (ie, the position of the posterior device was recalibrated and set to a more posterior and medial position, and the patients' gait was reassessed). At the end of the right boot calibration, the posterior device was 9 mm posterior and 6 mm medial to its original position.

Synchronization of heel raise: the patient was asked to walk 20 m to confirm that the heel raise is well synchronized in the gait cycle. An early heel lift was evident in the right foot. To correct this, the soft spacer between the anterior PB and the shoe of the right shoe was removed. I know A clinical gait evaluation was performed and it was noted that the heel raise on the right leg had normalized.

Repeat gait lab test: Once the balance process was complete, the patient performed another gait lab test with the device. The results of this test were significantly better than the initial results. Gait speed increased to 55.0 cm/s, left limb support only 27.3%, right limb support only 39.1%, left step length 37.2 cm, and left step length right was 39.3 cm (see Table 7 for detailed gait laboratory data). The data from this test showed that the walking speed was 49.1 cm/s, left single limb support: 25.6%, right single limb support: 41.6%, left step length 32 .7 cm and length of the right step 39.3 cm. (See Table 7 for detailed gait lab data.) These results show that the patient's gait is greatly improved by the device and that some of the improved motor control (for example, bearing more weight on the left leg thus increasing right step length) is retained for at least a short period of time. .

Table 7: Parameters of the patient's gait laboratory

Treatment plan: the patient was informed about the safety instructions and was instructed to start treatment using the device for a total time of one hour for each day of the first week, of which a total of 5 must be spent % to 10% in weight-bearing activities. Therefore, the cumulative weight loading time should be 3 to 6 minutes. The patient was seen for follow-up visits 10 days after the initial consultation, 3 weeks after the initial consultation, 5 weeks after the initial consultation, and 3 months after the initial consultation.

Treatment progression: At the end of the initial calibration process, the patient immediately felt less pain and ambulation was much easier with the shoe. At the first follow-up, he reported that the pain decreased when walking with the shoes on (to 1/10 on the VAS). He also reported that when he walked with the shoes he did not need the support of the walker. Walking without shoes was also significantly better with a pain level rated at a maximum of 3/10. The gait lab results showed a great improvement in barefoot gait. Gait speed was 73.0 cm/s, left single-limb support 33.3%, right single-limb support 39.4%, left step length 42.0 cm, and left step length right was 47.0 cm (see Table 7 for details of the barefoot gait laboratory test repeat). Due to the improvement and due to the fact that the differences between the support only of the right and left extremity and the step length were still significant, the patient still needed an unloading and asymmetric disturbance level. Therefore, the anterior and posterior PB of the left shoe were changed to a B level of convexity. Since the convexity of level B is higher than the convexity of level A, a hard spacer was removed from the posterior PB. This was done without changing the position of the PB. A hard spacer was also removed from the anterior protuberance, without changing its position. Clinical gait evaluation revealed that the patient had an early heel raise on the left leg. To correct this, a soft retractor was removed from the left anterior PB and the patients' heel rise time was normalized. The patient was asked not to increase the total time of use for 3-4 days to allow his neuromuscular control to adjust to the new calibration. After the first 4 days, the patient was asked to increase total shoe-wearing time by 15 minutes per week and maintain 10% of cumulative weight-bearing time.

At the second follow-up, the patient reported that he no longer needed any type of assistance to walk. His pain level decreased to 1/10 and he reported having the device on for 2 1/2 hours every day. During that time, he roams freely around the house. The gait lab data showed that the velocity was now 116 cm/s, left single limb stance 37.9%, right single limb stance 40.4%, left step length 64.1 cm and the length of the right step was 62.7 cm (see Table 7 for details on the repetition of the barefoot walk test). Therefore, the anterior and posterior PBs of the left device were changed to a C-level convexity. Since the C-level convexity is greater than the B-level of convexity that the left PBs had at the last calibration, it was removed. a hard retractor of the posterior pons. This was done without changing the position of the PB. A hard spacer from the previous PB was also removed, without changing its position. Clinical gait evaluation showed no gait deviations and the patient reported no pain or discomfort. Data from the gait lab with the device and a barefoot repeat test are provided in the table. 7. The patient was asked to increase the total time of shoe use by 20 minutes per week. She was instructed that within this time frame she should perform a period of continuous indoor walking starting at 10 minutes and increasing by 2 minutes per week. In the follow-up consultation carried out 3 months after the start of treatment, the patient reported being free of pain and having worked the total time of wearing the shoes up to 5 hours a day. During that time, he performed a 25-minute period of continuous indoor walking (see Table 7). There were no changes in the calibration performed at this follow-up visit. The patient was instructed to continue with the same treatment plan and return for another follow-up visit in 5 months.

Example 7: Right Bimalleolar Ankle Fracture (Open Reduction Internal Fixation)

A 37-year-old man presents to the treatment center 10 weeks after a bimalleolar ankle fracture treated by open reduction and internal fixation.

Medical History: The patient fractured his right ankle during a basketball game 10 weeks ago in an inversion mechanism. He underwent surgery that night and was advised to keep his leg weight-free for two weeks. Following staple removal, recommended partial weight bearing was performed. The patient was instructed by the treating surgeon to increase weight bearing as tolerated and was referred for physical therapy. He needed a cane to walk outdoors. Walking for more than 5 minutes was difficult and painful (4/10 on a VAS). The pain increased when going up or down stairs (5/10 and 6/10 respectively).

Physical examination: On observation there was moderate edema around the right foot and ankle. The patient was more weight bearing on the left leg. Ranges of motion measured with a manual goniometer revealed right dorsiflexion: 5 degrees, left dorsiflexion: 15 degrees, right plantar flexion: 45 degrees, left plantar flexion: 75 degrees. Palpation of the ankle produced mild tenderness at the anterior joint line and around the lateral malleolus. During clinical gait assessment it was apparent that the patient had insufficient dorsiflexion at the right ankle. This led to a shorter stance on the right and reduced the swing phase of the left leg. The patient reported pain in the anterior and lateral right ankle during the middle and late phases of the posture. He rated the pain as 5/10 on a VAS.

Imaging and Gait Laboratory: Radiographs of the right ankle showed that the fracture was well positioned and completely calloused. There were no apparent signs of damage to the subtalar joint or ankle. Gait lab data showed a gait speed of 65.1 cm/s, Left Step Length: 43.8 cm. , right step length: 50.2 cm, left single limb support: 43.2%, right single limb support: 31.7%.

Therapy Balance: The patient's footwear was calibrated and fine-tuned during repeated clinical evaluations of gait with the device. During this process, care is taken to reduce eversion and inversion during heel strike, load response, mid-stance, and toe-off.

Pain: PBs with a B-level convexity and "soft" hardness were placed and fixed under the hindfoot and forefoot of the right boot. To reduce pain during mid-position of the right leg (thought to be caused by limited dorsiflexion) two soft retractors were inserted and fixed between the PB right rear and outsole. This brought the right ankle into a slightly plantar flexed position. Additionally, this also created a certain degree of "offloading" of the right leg (see previous examples for details on "offloading"). PBs with C-level convexity and hard resistance were placed and attached to the rearfoot and forefoot of the left shoe. Since the PBs with level C convexity are higher than the PBs with level B convexity, the "offload" of the right leg was now lost. Therefore, two hard spacers were inserted and fixed between the shoe and the right posterior bulge, and two additional hard spacers were inserted and fixed for the right anterior PB. The patients' gait was clinically evaluated and showed higher speed, longer stance period of the right leg, and better step length symmetry. The patient reported that the pain in his right ankle was now at a level of 2/10 pain. To further decrease right ankle pain, the right posterior PB was calibrated and set 3 mm anterior to its original position. The patient reported that his pain level in his right ankle was now 1/10. An additional 2 mm anterior calibration of the right posterior PB did not produce any additional improvement in either gait quality or pain level. Therefore, the right posterior PB was calibrated and re-fixed 2 mm to its anterior position.

Timing of heel raise: The patient was asked to walk 20 m to confirm that he was still balanced and that the heel raise was well-synchronized within the gait cycle. There were no apparent gait deviations with respect to heel raise time in either the left leg or the right leg.

Treatment plan: The patient was informed about the safety instructions. They told him to wear the device for a total of 45 minutes a day every day for the first week. Of that total time, he was asked to perform weight-bearing activities for a cumulative amount of 9 to 10 minutes (20% of total wear time). The patient was instructed to increase total shoe-wearing time by 10 minutes each treatment week, while maintaining 20% of cumulative weight-bearing time. The patient was seen for follow-up consultations at the treatment center 2 weeks after the initial consultation, 5 weeks after the initial consultation, 3 months after the initial consultation, and half a year after the initial consultation.

Treatment Progression: As mentioned above, the patient had significantly reduced pain and found walking in the shoe much easier during the initial calibration process. At the first follow-up visit, the patient reported that walking indoors without shoes was easier and less painful than before (indoor walking pain level 2/10) although he still needed to use the cane for longer walks outdoors . Increased the total time of shoe use to one hour and 15 minutes. Gait lab data showed gait speed increased to 78.0 cm/s, right step length and left step length increased, and symmetry in step length was better (left-48, 9cm right-52.3cm). Single limb support values also improved and had better symmetry (left: 41.0% right: 33.2%). Due to the positive effects on pain level and gait parameters, the calibration was left unchanged. The patient was asked to increase total wear time by 15 minutes each week while maintaining the relative 10% of cumulative weight-bearing time.

At the second follow-up visit, the patient reported that walking outdoors was much less painful (pain level decreased to 1-2/10) and he stopped using the cane. He wore the device for 2 hours a day and walked with it without pain. The gait laboratory parameters were: speed: 105.5 cm/s, left step length: 54.3 cm, right step length: 57.1 cm left single limb support: 39.5%, a single right extremity: 37.8%. Due to decreased pain and greatly improved gait laboratory parameters, "offloading" and asymmetry in disturbance were thought to be unnecessary. The anterior and posterior PB of the right device were changed from level B convexity to level C convexity. The soft spacers placed between the sole and the base of the right posterior PB were removed, and then the PB was fixed in the same position. The patient's gait was reassessed and the patient reported mild pain (1/10 on a VAS) during the late stance phase. To alleviate this pain, the retractor was removed from under the right anterior pons. The bulge snapped back into position. This brought the right ankle into a slightly plantarflexed position. The patient then reported that he had no pain in his right ankle when walking with the device. The patient was then instructed to continue the current total treatment time for one week to allow his neuromuscular control to adjust to the new calibration. After that week, he was asked to increase the total treatment time by 15 minutes each week to a maximum of 4 hours. She was also instructed, after the first week after consultation, to perform normal indoor daily activities when wearing the shoes.

At the third follow-up, the patient reported that he had no pain in his right ankle. The gait laboratory parameters are presented in Table 8. BPs with a degree of convexity D were placed and fixed to the anterior and posterior BPs of the right and left devices. The hard retractor was removed from the right posterior pons. After these changes, all PBs (on the left and right devices) were connected and fixed in their previous position. Clinical gait evaluation with the device revealed no gait deviation and the patient reported no pain or discomfort. The patient was allowed to walk outside while wearing the shoes.

Claims (14)

1. A shoe (10) comprising: a support member (12) having an inner sole and an upper surface that can be attached to a foot, and two bulbous nubs (22, 218, 220), a front bulbous nub (22, 218) and a rear bulbous nub (22, 220), each having a curved outer contour, projecting from a lower surface of said support member on opposite sides of a latitudinal midline (30) thereof, said latitudinal midline (30) being at midway between a calcaneal support portion and a phalangeal support portion of said support member, wherein said forward bulbous protrusion (22, 218), said rear bulbous protrusion (22, 220) or both are positioned offset relative to to a longitudinal center line (28), wherein the ratio of the surface area of the inner sole to the surface area of a base of at least one bulbous nub of the two bulbous nubs (22, 218, 220) is less than 12:1, wherein, at least one bulbous protrusion of the two bulbous protrusions (22, 218, 220) has a Shore hardness of between 15 and 100 Sh A and an abrasion resistance of more than 80 mm3 and less than 125 mm3 according to DIN 53516, such footwear (10) being adapted to support the foot solely by said two bulbous protrusions (22, 218, 220) when said two protrusions (22, 218, 220) are placed on a ground surface. 2. The footwear of claim 1, wherein the front bulbous protrusion, the rear bulbous protrusion, or both, comprises a convexity delimited between the graphs of function 1:

and function 2:

said footwear is adapted to support the foot solely by means of said two bulbous protrusions when said two protrusions are placed on a ground surface. 3. The shoe of claim 1 or 2, wherein the forward bulbous bulge is positioned laterally offset from a longitudinal centerline, wherein the rear bulbous bulge is positioned medially offset from a longitudinal centerline, or both. 4. The footwear of claim 1 or 2, wherein the height of the front bulbous protrusion is greater than the height of the rear bulbous protrusion or wherein the height of the rear bulbous protrusion is greater than the height of the front bulbous protrusion . 5. The footwear of claim 1 or 2, wherein both the front bulbous bulge and the rear bulbous bulge comprise an abrasion resistance of less than 125 mm3 according to DIN 53516. 6. The shoe of claim 1 or 2, wherein the front bulbous bulge, the rear bulbous bulge, or both comprise studs. 7. The footwear of claim 1, wherein the front bulbous protrusion, the rear bulbous protrusion, or both, comprises a convexity delimited between the graphs of function 1: f ( x ) = SVx and function 2:

8. The footwear of any of claims 1-7, wherein the deformation capacity of at least one of said bulbous protuberances after impact with the ground is minimized. 9. A method for preparing footwear (10), the footwear (10) comprising a support member (12) having an upper surface attachable to a foot, and two bulbous protrusions (22, 218, 220), one a forward bulbous protrusion (22, 218) and a rear bulbous protrusion (22, 220), each bulbous protrusion having a curved outer contour, protruding from a lower surface of said support member (12) on opposite sides of a median line latitudinal (30) thereof, said latitudinal midline (30) being midway between a calcaneus supporting portion and a phalangeal supporting portion of said supporting member (12), wherein the forward bulbous bulge (22, 218) is positioned laterally offset from a longitudinal center line (28), wherein the ratio of the surface area of the insole to the surface area of a base of at least one bulge bulbosa of the two bulbous protuberances (22, 218, 220) is less than 12:1, wherein at least one of the two bulbous protrusions (22, 218, 220) has a Shore hardness of between 15 and 100 Sh A and an abrasion resistance greater than 80 mm3 and less than 125 mm3 according to DIN 53516 standard, said shoe (10) being adapted to support the foot solely by means of said two bulbous protrusions (22, 218, 220) when said two protrusions (22, 218, 220) are placed on a ground surface, the method comprising: placing at least one protrusion (22, 218, 220) on said bottom surface of said support member (12). 10. The method of claim 9, wherein said placement comprises fixing or mounting. 11. The method of claim 9, wherein said placing at least one protrusion is placing two bulbous protrusions. 12. The method of claim 9, wherein the rear bulbous protrusion is positioned medially offset from the longitudinal centerline. 13. The method of claim 9, wherein the height of the forward bulbous protrusion differs from the height of the rear bulbous protrusion. 14. The method of claim 9, wherein each of the leading bulbous bulge and the trailing bulbous bulge has a convexity bounded between the graphs of function 1:

and function 2: