WO2019201403A1

WO2019201403A1 - Indication device

Info

Publication number: WO2019201403A1
Application number: PCT/DK2019/050119
Authority: WO
Inventors: Finn Christian Simonsen
Original assignee: Pinpoint Biomechanics Holding Ivs
Priority date: 2018-04-18
Filing date: 2019-04-12
Publication date: 2019-10-24

Abstract

An indication device comprises an elongated indication pin connected to a base, said being base suitable to be arranged on a heel section of a shoe or other foot wear. The indication pin overlays the articulated joint or joint complex constituting the ankle, and the indication pins position relative to the articulated joint or joint complex is marked on a scale on the users heel or lower rear leg.

Description

Indication device

Field of the Invention

The present invention relates to an indication device as well as a method of using an indication device. The indication device is particularly designed to be temporarily applied on a heel portion of a shoe, while said shoe is being fitted on a user where in particular the indication device is used for investigating any articulated joint adjacent the foot region of a user, and in particular the heels pronation (hyperpronation nor hypersupination) relative to the lower leg.

Background of the Invention

A skeleton, be it a skeleton of a human being or an animal comprises a vast number of joints which nature has designed to function perfectly such that the body will be able to move effortless and painlessly according to the design of the body. However, in some situations misalignment of body parts occurs for example due to deformations, broken limbs, monotonous wear etc. etc.

In order to compensate for this, the body is usually examined by an expert be it a physiotherapist or a doctor who due to his or her experience and judgment decides on measures to be taken in order to compensate and correct the misalignment or defor mation such that proper treatment, therapy or use of devices may be implemented in order to compensate or alleviate the misalignment. Basically the basis for the entire procedure is the subjective judgement of the expert treating that particular body.

Typically an expert will judge and evaluate the situation from the expert’s experience, and as such a physiotherapist may view and evaluate a situation differently from a medical expert (or another physiotherapist) due to the difference in background and knowledge. This may cause vastly different treatments and success rates.

Particularly for the examination of the human foot there is a need for particular atten tion, as the foot/ankle comprises many articulated joints. In the physiological analysis and treatment of various conditions related to the posi- tion of various parts of the foot, it is relevant and necessary to perform a qualitative or quantitative measurement of the actual scope of the condition. In relation to more common daily routines as selecting the right footwear for a specific type of foot alignment during for example running it is likewise relevant to make a qualitative or quantitative analysis of the actual condition in order to ensure the right choice or recommendation regarding footwear. Previously it has been a normal procedure to provide an indication by making a mark ing, e.g. a line, on a person’s foot and lower leg and following this during movement, either entirely visually by eye or by video recording, eventually assisted by kinematic or kinetic systems. This has worked to some extent, but a significant uncertainty is connected with this measurement and hence a need for improvement is present.

One example of such a technique is disclosed in WO 02/076295. Jere it is suggested to fasten a device comprising a number of markers to the heel of the person to be inves- tigated. For tests/investigations where it is desirable to investigate the articulation of the foot’s joints when the user is wearing foot wear, an aperture is created in the heel region of the foot wear in order for the device which is attached to the heel to be able to protrude through this aperture, and be measurable from outside the shoe.

The objective of the present invention is to provide an improved indicator that will enable an easier and more reliable analysis of the foot motion, particularly when the investigation includes a person wearing footwear. Particularly for certain types of foot wear they are worn so intimate with the foot that use of an indication device for ex- ample as proposed in WO 02/076295 or WO 2017/092765, will not provide reliable results.

Object of the Invention

Consequently, it is an object of the present invention to provide a device which facili tates a more objective judgement of the status of the articulated joint or joint complex or involved body segments, in the actual wear situation, without affecting the correct wear of the shoe wear.

Description of the Invention

The invention addresses this object by providing a method of using an indication de- vice for investigating an articulated joint or joint complex of a particular user while said user is actually wearing a particular piece of footwear, particularly with respect to the position of a user’s ankle position with respect to pronation, supination and a neu- tral position while wearing the footwear, wherein said indication device comprises an elongated indication pin connected to a base, said base suitable to be temporarily ad- hered to a heel section of the shoe wear, such that the indication pin overlays the ar ticulated joint or joint complex constituting the ankle, and where the indication pins position relative to the articulated joint or joint complex is marked on a scale on the users heel or lower rear leg, indicating the articulated joint or joint complex’ position. With this method it is possible to register the actual conditions for a user wearing a specific footwear. It will therefore be possible to for example experiment with differ ent insoles in order to modify the actual foot wear such that the foot wear will provide the best possible wear characteristics to the user. The results of the experiments with for example insoles are immediately detectable, simply by looking at the scale provid- ed. Simple, fast and yet very reliable.

A suitable indication device is also disclosed. The indication device may resemble the indication device published in WO 2017/092765, however modified such that the base is attachable (and detachable) to an ankle portion of foot wear (shoe). This requires the attachment means to be specifically adapted to the attachment to fabric or leather, such that as the base is removed, it will leave no traces. Furthermore the elongated element (the pointer) shall be either provided with a slight bend, such that the elongat ed element comes into lose proximity with the lower leg, or the elongated element shall be bendable, so that it may be deformed during use.

In a further embodiment of the method of using an indicator device for investigating an articulated joint or joint complex of a particular user, is foreseen that particularly with respect to the position of a user’s ankle position with respect to pronation, supi- nation and a neutral position, wherein a center line is drawn extending from the users heel and along whole or part of the lower rear leg, said center line indicating a theoret- ical neutral position, where said indicator device comprises an elongated indication scale connected to a base, where said base suitable to be temporarily adhered to an ankle of the user or an outer wear item of said user, such that the indication scale over lays the articulated joint or joint complex constituting the ankle, and where the indica- tion scale position relative to the center line on the users heel and/or lower rear leg, indicates the articulated joint or joint complex’ position with respect to pronation, supination or neutral position on the scale.

With this method it is possible to register the actual conditions for a user with respect to pronation, supination or neutral position as a tool for choosing and wearing specific footwear. It will therefore also be possible to for example experiment with different insoles in order to modify the actual foot wear such that the foot wear will provide the best possible wear characteristics to the user. The results of the experiments with for example with or without insoles are immediately detectable, simply by looking at the indication scale provided relative to the center line drawing on the user’s foot and/or leg. Simple, fast and yet very reliable. The base is flexible and where said indication scale is pre-printed with scale marks facilitating correct placement of the indication scale on the user, such that the actual pronation, supination or neutral position may be observed on the indication scale, when compared to said center line drawn on the user. The base may be substantially flexible, suitable to be temporarily adhered to the skin of a user, on which indication scale may have pre-printed scale marks divided into zones facilitating correct placement of the indication scale on the user, such that the actual pronation may be observed. The indication scale is measuring the movement of the center line as an absolute measurement in either distance or in angular pivoting or in rotation or as an interval of movement, where the scale marks on the indication scale are indicated with one or more pre-printed zones showing a range of displacement in either distance or angular pivoting or rotation. The pre-printed are defined by using colour scale or sequins of numbers provided on the indication scale, indicating the degree of pronation or supination. The indication scale's position relative to said center line drawn on the user’s foot and/or leg is ob- served indicating the actual pronation, and thereafter compared to a theoretical opti- mum pronation or supination.

The indicator device is placed on a piece of footwear while said user is actually wear ing the particular piece of footwear, particularly to a heel section of the shoe wear.

The Indicator device comprises an elongated indication scale extending from the base, where said base is provided with means for detachably attaching said base to a heel section of a user or to a foot wear worn by the user. Indicator device is an agile and easy process of investigating an articulated joint or joint complex of a particular user, particularly with respect to the position of a user’s ankle position with respect to pro- nation, supination and a neutral position.

The indication scale's position is registered relative to said center line on the user is used in order to modify the shoe wear to compensate for any pronation or supination.

The indication scale may be positioned relative to the center line indirectly illustrates the articulated joint or joints, may be marked on the user’s foot or lower leg using film, marker or similar, indicating the actual pronation, and thereafter compared to a theoretical optimum pronation. The ankle, or the talocrural region, is the region where the foot and the leg meet. The ankle includes three joints: the ankle joint proper or talocrural joint, the subtalar joint, and the inferior tibiofibular joint. The movements produced at this joint are dorsiflex- ion and plantarflexion of the foot. In common usage, the term ankle refers exclusively to the ankle region. In medical terminology, "ankle" (without qualifiers) can refer broadly to the region or specifically to the talocrural joint.

The main bones of the ankle region are the talus (in the foot), and the tibia and fibula (in the leg). The talocrural joint is a synovial hinge joint that connects the distal ends of the tibia and fibula in the lower limb with the proximal end of the talus. The articu- lation between the tibia and the talus bears more weight than that between the smaller fibula and the talus.

During the application stage of the indicator device to the foot wear the practitioner’s experience is important in that the indication scale shall be aligned correctly with re- spect to that particular joint or joint complex or particular complex of body segments which is being examined.

Particularly, some types of sports shoes are either manufactured to the user’s exact specifications or are so tight fitting that it is not possible to measure directly on the body. As these types of shoes move very closely with the rest of the foot, a very accu- rate indication/measurement is obtained by arranging the indicator device on the heel section of the shoe itself.

Said indicator device comprises an elongated indication scale extending from a base, where said base is provided with means for detachably attaching said base to a heel section of a user or to foot wear worn by said user, wherein use said indication device is adapted to measure an angular movement of a center line and/or a longitudinal movement of the center line and/or a rotational movement of the center line where the scale is showing the movement of the center line as an absolute measurement in either distance or in angular pivoting or in rotation or as an interval of movement, where the Further embodiments are listed in further dependent claims which propose:

A further method embodiment wherein the scale is a flexible film, suitable to be tem porarily adhered to the skin of a user, on which scale is pre-printed indication marks facilitating correct placement of the scale on the user, such that the actual pronation may be observed; and/or

wherein the indication pin’s position relative to the articulated joint or joint complex is marked on the user’s foot or lower leg indicating the actual pronation, and thereafter compared to a theoretical optimum pronation; and/or wherein the position registered on the user, is used in order to modify the shoe wear to compensate for any pronation or supination.

The invention is also directed at an indication device wherein said indication device comprises an elongated indication pin extending from a base, where said base is pro- vided with means for detachably attaching said base to a heel section of foot wear.

Further embodiments suggest that the indication device further comprises a scale ex- tending from the base and arranged on or behind the indication pin, where markings are provided on the scale facing the indication pin; and/or

that the scale is provided to estimate the movement of the elongate element, where the scale is adapted to measure an angular movement of the elongate element and/or a longitudinal movement of the elongate element and/or a rotational movement of the elongate element where the scale is showing the movement of the elongate element as an absolute measurement in either distance or in angular pivoting or in rotation or as an interval of movement, e.g. indicated with colours on the scale showing a range of displacement in either distance or angular pivoting or rotation; and/or

that the scale at least in certain areas may be provided with adhesive means suitable to adhere the scale to the surface of the body; and/or

that the base is flexible and may be deformed to fit closely to the foot wear, and where the indication pin is rigid; and/or

that a scale is applied to the body part on the opposite side of the joint or joint com plex to where the base is applied, where the scale is applied prior to movement of the articulated joint or joint complex; and/or

that the scale is a thin film having printed indications, said indications particular to the particular articulated joint which is being investigated; and/or

that the scale is printed or indicated directly on the body.

During the application stage of the indication device to the foot wear the practitioner’s experience is important in that the indication pin shall be aligned correctly with re- spect to that particular joint or joint complex or particular complex of body segments which is being examined. Particularly, some types of sports shoes are either manufactured to the user’s exact specifications or are so tight fitting that it is not possible to measure directly on the body. As these types of shoes move very closely with the rest of the foot, a very accu- rate indication/measurement is obtained by arranging the indication device on the heel section of the shoe itself.

In a further advantageous embodiment of the invention the indication device further comprises a scale extending from the base and arranged on the elongate element and/or behind the indication pin, where markings are provided on the scale facing the indication pin.

The scale will be able to give an objective reading of the relative angle between the two body parts, when the foot wear is worn, on either side of the articulated joint. This reading is of course dependent on the practitioner’s proper application of the indica- tion device. However, it is contemplated that the scale may be the same for indication devices, for example used in order to investigate the ankle joint such that the reading on the scale if so desired may be the same for all ankle joint investigations and thereby it becomes possible to compare results from one investigation with results from anoth er investigation.

In this manner it is possible to generate a number or numbers on the scale or a zone on the scale which may be denoted as normal and likewise, if the indication pin is in cer tain positions relative to the scale, this may be denoted abnormal and requiring treat ment.

In a further advantageous embodiment the scale at least in certain areas may be pro vided with adhesive means suitable to adhere the scale to the surface of the body.

Often the investigation of the articulated joint requires movement in order to investi- gate the joint’s spatial position or movement and consequently if the scale was com pletely loose the scale may move with the indication pin and thereby not provide the correct readings whereas if the scale is adhered to the joint and in particular on the other side of the joint as to where the base of the indication device is adhered, the rela- tive movement between the scale and the indication pin will give a proper and correct reading.

It is also contemplated to mark the scale on the body’s surface, for example as a tem porary tattoo, transfer colouring, or spray painted through a stencil.

In a further advantageous embodiment of the invention the indication device is ad- hered to the foot wear by an adhesive provided on the base covered by a protective cover which is removed prior to application of the device.

By providing a protective cover on the base it is possible to manufacture the indication device in large numbers, store them and send/distribute them without the adhesive losing its adhesive properties.

In a still further advantageous embodiment of the invention the base is flexible and may be deformed to fit closely to the foot wear and where the indication pin is rigid.

In this manner it is possible to adapt the base to the foot wear such that a firm and solid connection is provided between the base and the foot wear and thereby between the indication device and the body part which it is desirable to investigate. The rigid pin naturally provides less deflection such that a reading of the relative angle between the two articulated body parts may be more precise.

In a further advantageous embodiment the base is further provided with tear lines, such that upon removal of the base, the base will tear along the tear lines. By provid- ing tear lines the base will tear when the indication device is removed from the foot wear. The ensures that the device is only for one time use and consequently that the indication device specifically where the indication device is provided with scales suit- able to indicate normal and not normal relative angles for specific joints is not reused such that an incorrect indication device may be applied to a wrong articulation joint and thereby provide misinformation instead of providing correct information.

Also from a hygienic point of view it is important that the device is for one-time use only. As the device comes into intimate contact with the skin of a body it is important not to re-use the device on another body as bacteria or other undesirable matter may be transferred, and thereby potentially be a cause of contamination.

The indicators will in many embodiments have a cross-shape, where reference points are placed at the three distal ends of the cross (the fourth end being integral with the base).

The indication device and/or the scales may in a further advantageous embodiment be provided with active or passive indicators.

Passive indicators are indicators which clearly indicate the position of the indicator and are detectable by observation detection instrumentation or observation detection systems. Particularly in situations where a user is being filmed or in other manner reg- istered during movement the indicators will provide a clear and objective indication of the spatial position and movement of the joint, during the particular movement of the articular joint.

Active indicators could for example be GPS transponders, RFID or other suitable in dicators which emits a signal. As is the case with passive indicators, the active indica- tors may be registered during motion, thereby assist in mapping the movement of an articulated joint.

These analysis, involving both passive and active indicators, may be carried out in 2D or 3D (using a plurality of cameras or detectors) and by means of suitable software, map the entire spatial position or movement in 2D or 3D and time. Compared to the subjective visual analysis carried out by a practioner, 2D or 3D complete animated mapping provides an increased objective level of insight into the particular joints movements.

Common for all the indicator device embodiments is the fact that the indicator device embodiments can be applied and their indications read while the person being investi- gated is clothed and/or wearing shoes, as the indication pin will project outside the clothing or shoes. This particular aspect is very useful. Particularly with shoes, if e.g. an insole or the shoe itself is meant to compensate for, for example pronation, the ef- feet of the insole can be objectively detected with the shoe on. At present an investiga- tion is mainly carried out bare-footed and an estimate is used to estimate the correc- tion needed, whereas with the present invention the result of the correction by assis- tive devices such as e.g. insoles or shoes or taping or by therapeutic or treatment in terventions such as e.g. surgery can objectively be determined simply by reading the indication pins position on the scale.

In embodiments where a scale or measurement scale is provided, the measurement scale is being provided to estimate the movement of the elongate element, where the measurement scale is adapted to measure an angular movement of the elongate ele- ment and/or a longitudinal movement of the elongate element and/or a rotational movement of the elongate element.

Such scale may show the movement of the elongate element as an absolute measure- ment in either distance or in angular pivoting or in rotation or as an interval of move- ment, e.g. indicated with colours showing a range of displacement in either distance or angular pivoting.

The measurement scale may be adapted to be fixed onto the skin, e.g. through an ad- hesive applied on the measurement scale. Hereby the scale will follow the movement of the body segment e.g. the leg above the fixation of the indicator at the distal end of the elongate element.

The elongate element may be manufactured from at least two materials with different degrees of flexibility and mutually connected, e.g. through a moulding process includ- ing adhesive attachment.

In a further embodiment one or more reflective or otherwise identifiable markers are attached to the indicator's elongate element and/or the scales. Hereby the use of the indicator may be further included in motion analysis e.g. in connection with video recordings, where also markers on other body parts may be included.

As an option the attachment means are of a type allowing only single use. This will increase the sanitary conditions related to use. In practice the method may be carried out as follows:

When attaching the indicator it is of significant importance for the measurement result that this is done at the correct location of the foot wear, relative to the person’s rest position.

The following is describing a method for measuring the inclination and/or longitudinal and/or rotational movements of Os Calcaneus in the frontal plane and the position of Os Naviculare over a substrate.

Visual observation of the hind foot:

From Posterior i.e. with visual direction from behind and towards the person.

With the direction exactly levelled with height of the Achilles tendon (Tendo Calce- neo/Tendo Achillis) attachment to the heel bone (Os Calcaeneus).

With visual direction directly along the extension of the foot center line - independent of the foot rotation in the horizontal plane in the Mid- Stand-Phase - where, if standing or walking or running on a horizontal surface, the lateral malleolus is vertically below Trochanter Major.

To do prior to visual observation:

The height of Tendo Achillis attachment to Os Calceneus relative to the substrate is measured and registered.

Posterior camera or observer's eye is adjusted in this height.

Direction of the foot center line in the horizontal plane - equal to the direction of a straight line from the heel center line to the separation between the 2. and 3. toe.

Posterior camera or observer's eye is adjusted in the extension and straight direction of this line.

Os Calceneus' sagittal center line seen in posterior view. The observer positions himself behind the patient centrally and above the extension of the foot center line in the horizontal plane.

With left and right thumbs Os Calceneus is medially and laterally palpated as distally as possible with opposite directed and equal pressures through the skin.

A point is marked as distal as possible on Os Calceneus on the sagittal center line.

With left and right thumbs Os Calceneus is medially and laterally palpated as proxi- mally as possible with opposite directed and equal pressures through the skin.

A point is marked as proximal as possible on Os Calceneus on the sagittal mid line.

A line is marked between the proximal and the distal points - representing the Os Cal- ceneus' sagittal mid line.

The indicator is applied on the skin on the Os Calceneus' sagittal center line.

Os Calceneus' inclination in corrected hind foot position:

The patient is standing upright with straight knees and looking forward.

The observer places himself sitting or kneeling centrally in front of the patient.

The observer grips the patient's right knee cap with his left hand and with the right hand the left knee cap.

The observer helps the patient by use of hands and verbal instruction to rotate both patient's legs outwards in the hip joints - with extended knees.

The observer helps the patient by use of hands and verbal instruction to rotate both patient's legs inwards in the hip joints - with extended knees.

The patient repeats these movements, with help from the observer until possible to do these movements on his/her own.

The observer palpates with thumb and index finger the Os Talus necks on the patients feet while the patients conducts slow outwards and inwards rotations according to the observer's verbal instructions.

The observer palpates Os Talus neck, while it shifts medially and laterally.

The observer instructs the patient to maintain the specific rotation of his/her legs until the Os Talus neck is palpated equally medially and laterally.

The observer observes and measures with an angular measurement the inclination of Os Calcaneus' sagittal center line with the patient's hind foot in this position. The measured inclination of Os Calceneus' sagittal center line is registered as the rear foot corrected angle.

The corrected angle is expressed in Varus (- degrees), Neutral (0 degrees) or Valgus (+ degrees).

Os Calceneus' inclination in uncorrected hind foot position:

The patient relaxes from the instructed rotation of his/her legs and lets the foot rest in its uncorrected position.

The observer observes and measures the inclination of Os Calceneus' sagittal center line with the patient's hind foot in this position.

The hereby measured inclination of Os Calceneus' sagittal center line is registered as the hind foot uncorrected angle.

The uncorrected angle is expressed in Varus (- degrees), Neutral (0 degrees) or Valgus (+ degrees).

Os Naviculare's height over the substrate in corrected hind foot position:

The observer instructs the patient to position and maintain the specific rotation of the legs where Os Talus necks are equally prominent when palpated medially and lateral- iy.

The observer observes and measures with a height measurer the height of Os Navicu- lare over the substrate with the patient's hind foot in this position.

The hereby measured height is registered as the Os Naviculare's corrected height.

The Os Naviculare's corrected height is expressed in mm.

Os Naviculare's height over the substrate in uncorrected hind foot position:

The hereby measured height is registered as the Os Naviculare's uncorrected height. The Os Naviculare's uncorrected height is expressed in mm. Indicator is applied on a shoe in the vicinity of the Os Naviculare's prominence with the elongate element pointing in proximal direction.

Kinematic and/or kinetic recordings and analysis may now be performed, with foot- wear.

Description of the Drawing

The invention will now be explained with reference to the accompanying drawing wherein

Figure 1 and 2 illustrate embodiments of an indication device

Figure 3 illustrates a further embodiment where the device is

provided with a scale on the elongate element and/or behind the elongate element

Figure 4 and 5 illustrate the application of an indication device to a shoe worn by a person

Figure 6a-c illustrates pronation of an ankle

Figure 7 Illustrates embodiments of an indicator device

Figure 8a,b,c,d Illustrates pronation and supination of ankles, and the use of an indicator device

Detailed Description of the Invention

In figure 1 and 2 are illustrated an indication device 1 according to the present inven tion. The indication device 1 has a base part 2 connected to or integral with an elon gated indication pin 3. In this particular embodiment depicted in figure 1 the base part 2 is provided with tear lines 4 such that when removing the indication device from a body part the base part 2 will tear and it will be necessary to use a new indication de vice 1 for further investigations.

Naturally the base part 2 may also be manufactured without tear lines 4 such that it is possible to retrieve the indication device without destroying the base part.

In figure 2 is illustrated a cross section through the indication device 1 in order to il lustrate that the indication device 1 may advantageously have a curved shape. The particular shape indicated in figure 2 is particularly useful for investigating ankles. The curvature of the base part is designed to follow the curvature of the heel (or other body part) whereas the angle of the indication pin is provided in order to make sure that the pin does not interfere with the body and as such can move freely with respect to the body part and thereby indicate the rotation relative to the fastening point of the base 2 to the shoe 7. The dashed line 10 indicates where the articulated joint should be positioned relative to the indication device 1 such that the base part 2 will be fastened on one part of the joint whereas the indication device will indicate the other part of the joint’s relative angle with respect to the base part.

In figure 3a and 3b is illustrated another embodiment of the present invention where the base part 2 is provided with a connected or separate scale 5. In this embodiment the scale is provided with indication marks 6 such that the relative movement of the indication pin 3 relative to the base may objectively be determined as an indication on the scale 5.

It is also contemplated that in place of the indication mark 6 the scale may be divided into coloured zones or the like such that a clear and easy reading on the scale without being tied to a specific number may be available to the user. For example if the indica- tion devices 1 are developed in order to indicate the angle relative to the shinbone (Tibia) as will be explained further with reference to figure 6 the indication device 1 may be provided in a left-foot and right-foot version where the scale 6 includes a green area which is to considered normal and for example a yellow area where a slight deviation from normal is present and a red area where a grave deviation from normal is indicated such that it is easy for a not so experienced user to immediately detect whether or not it is necessary to investigate further and possibly start some type of treatment.

Also in figure 4 and 5, an indication device 1 is provided on the heel of a shoe 7 worn by a user in order to detect the situation which is illustrated with respect to figure 6 where the normal situation of the heel/shinbone is illustrated in figure 6a where over pronation is illustrated in figure 6b and under pronation is illustrated in figure 6C. For ankles indicators if they include a scale should have right and left side version being applied to respectively right and left foot, arm or shoulders such that the scale will give the correct indication.

In figure 5 is illustrated a human foot 6 in a shoe 7 with a device 1 according to the invention applied to the shoe 7. As is clear from the illustrations the indicator will move, and since the base 2 of the device 1 is adhered to the outside of the shoe, the movement of the indicator pin 3 is clearly identifiable as an indication of the ankle’s movement relative to the base.

One example of using the indication device 1 and in particular the indication device discussed above with reference to figures 3a and 3b used in order to determine the ankle’s position as described with reference to figure 8 is for the determination of for example insoles for footwear 7. It is contemplated within the present invention that manufactures of footwear more or less in a standard fashion manufacture insoles which addresses e.g. the pronation of a user such that for example once a user has had an examination performed using an indication device as illustrated with reference to figures 3a and 3b a number of the scale 6 will be indicated and correspondingly the shoe manufacturer will provide insoles corresponding to normal standard factors such that a customer will be able to pick out a certain shoe type having a certain standard size, for example size 8, with a pronation plus or minus 1, 2 or 3 or whatever will be- come the standard.

An embodiment of the invention is explained in the following detailed description. It is to be understood that the invention is not limited in its scope to the following de- scription or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or carried out in various ways.

In figure 1 is illustrated an indicator device 1 according to the present invention. The indicator device 1 has a base part 2 connected to or integral with an elongated indica- tion scale 3. In this particular embodiment depicted in figure 1 the base part 2 is pro- vided with tear lines 4 such that when removing the indicator device from a body part the base part 2 will tear and it will be necessary to use a new indicator device 1 for further investigations. Naturally the base part 2 may also be manufactured without tear lines 4 such that it is possible to retrieve the indicator device without destroying the base part.

The particular shape indicated in figure 1 is circular which including an aperture, where the tear lines 4 are symmetrically arranged in a circumference of the circle. The base part is designed to follow the curvature of the heel (or other body part) whereas the angle of the indication scale is provided in order to make sure that the indication scale does not interfere with the body and as such can move freely with respect to the body part and thereby indicate the rotation relative to the fastening point of the base 2 to for example a shoe, which is useful for investigating ankle movements.

The base part 2 is provided with scale mark 5 in the end of the elongated indication scale 3 in the opposite end of the base 2. In this embodiment the indication scale 3 is provided with scale marks 5 divided into indication zones 6 such that the relative movement of the indication scale3 relative to the center line may objectively be de- termined as an indication on the scale mark 5.

It is also contemplated that in place of the scale mark 5 the scale may be divided into coloured zones 6 or the like such that a clear and easy reading on the scale without being tied to a specific number may be available to the user. For example if the indica- tor devices 1 are developed in order to indicate the angle relative to the shinbone (Tib- ia). The indicator device 1 may be provided in a left-foot 1 'and right-foot version 1 ", where the scale zones 12 includes a first area which is to considered normal, and for example a second area where a slight deviation from normal is present and a third area where a grave deviation from normal is indicated such that it is easy for a not so experienced user to immediately detect whether or not it is necessary to investigate further and possibly start some type of treatment.

For ankles, indicator devices should have a right and left side version being applied to respectively right and left foot, arm or shoulders such that the scale will give the cor rect indication.

Fig. 8a and fig. 8 b illustrate a pronation of ankles and the use of an indicator device 1. A center line 13 is drawn on the center of the heel 14 and/or the part of the lower leg 15. The indicator device 1 may be provided in a vertical position on the heel 14 or on a heel of a shoe worn by a user in order to detect the situation. The indication scale is arranged in a direction toward the back side of the user’s knee. The normal situation of the heel/shinbone is illustrated in figure 8a and 8b, which is defined at an angle of 90° a. L is the left foot and R is the right foot, viewed from the rear side. Fig. 8a illus trates a center line 13 marked on a user, right R and left L foot separately. Fig. 8b il- lustrates one example of attachment of the indicator device 1 in regards to location and direction on the foot.

Fig. 8c illustrates a pronation, below 90°. In this example the indicator device 1 is attached to the heel of the left L foot, and the gradient is showed in the indication zone 12 relative to the center line 13, turning clockwise.

Fig. 8d illustrates a supination, above 90°. In this example the indicator device 1 is attached to the heel of the left L foot, and the gradient is showed in the indication zone 12 relative to the center line 13, turning counter clockwise.

One example of using the indicator device 1 and in particular the indicator device 1 discussed above with reference to figures 8c and 8d used in order to determine the ankle’s position is for the determination of for example insoles for a compensated footwear.

It is contemplated within the present invention that manufactures of footwear more or less in a standard fashion manufacture insoles which addresses e.g. the pronation of a user such that for example once a user has had an examination performed using an indicator device 1 as illustrated with reference to figures 8c and 8d. A number/colour of the indication zones 12 on the scale mark 11 relative to the center line 13, will be indicated and correspondingly the shoe manufacturer will provide insoles correspond- ing to normal standard factors such that a customer will be able to pick out a certain shoe type having a certain standard size, for example size 8, with a pronation plus or minus 1, 2 or 3 or whatever will become the standard.

In this manner the indicator device 1 of the present invention will have application in the consumer market and not only be adaptable for specialists investigating articulated joints.

Claims

1. Method of using an indication device for investigating an articulated joint or joint complex of a particular user while said user is actually wearing a particular piece of footwear, particularly with respect to the position of a user’s ankle position with re- spect to pronation, supination and a neutral position while wearing the footwear, wherein said indication device comprises an elongated indication pin connected to a base, said base suitable to be temporarily adhered to a heel section of the shoe wear, such that the indication pin overlays the articulated joint or joint complex constituting the ankle, and where the indication pins position relative to the articulated joint or joint complex is marked on a scale on the users heel or lower rear leg, indicating the articulated joint or joint complex’ position.

2. Method according to claim 1 wherein a center line is drawn extending from the us- ers heel and along whole or part of the lower rear leg, said center line indicating a the- oretical neutral position, where said indicator device comprises an elongated indica- tion scale connected to a base, where said base is suitable to be temporarily adhered to an ankle of the user or an outer wear item of said user, such that the indication scale overlays the articulated joint or joint complex constituting the ankle, and where the indication scales' position relative to the center line on the users heel and/or lower rear leg, indicates the articulated joint or joint complex’ position with respect to pronation, supination or neutral position on the scale.

3. Method according to claim 2 wherein said base is flexible, and where said indica- tion scale is pre-printed with scale marks facilitating correct placement of the indica- tion scale in relation to said center line on the user, where the actual pronation, supina- tion or neutral position may be observed on the scale on the indicator device when comparing the scale marks on the indication scale to said center line drawn on the user.

4. Method according to claim 2, where the indication scale is measuring the move- ment of the scale relative to the center line as an absolute measurement in either dis- tance or in angular pivoting or in rotation or as an interval of movement, where the scale marks on the indication scale are indicated with one or more pre-printed zones showing a range of displacement in either distance or angular pivoting or rotation.

5. Method according to claim 1 wherein the scale is a flexible film, suitable to be tem porarily adhered to the skin of a user, on which scale is pre-printed indication marks facilitating correct placement of the scale on the user, such that the actual pronation may be observed.

6. Method according to claim 2 wherein the indication pin’s position relative to the articulated joint or joint complex is marked on the user’s foot or lower leg indicating the actual pronation, and thereafter compared to a theoretical optimum pronation.

7. Method according to claims 2 or 5 wherein the position registered on the user is used in order to modify the shoe wear to compensate for any pronation or supination.

8. Indication device for use in a method according to any of claims 1 to 7 wherein said indication device comprises an elongated indication pin extending from a base, where said base is provided with means for detachably attaching said base to a heel section of foot wear.

9. Indication device according to claim 8 wherein the indication device further com prises a scale extending from the base and arranged on or behind the indication pin, where markings are provided on the scale facing the indication pin.

10. Indication device according to claim 9 where the scale is provided to estimate the movement of the elongate element, where the scale is adapted to measure an angular movement of the elongate element and/or a longitudinal movement of the elongate element and/or a rotational movement of the elongate element where the scale is showing the movement of the elongate element as an absolute measurement in either distance or in angular pivoting or in rotation or as an interval of movement, e.g. indi cated with colours on the scale showing a range of displacement in either distance or angular pivoting or rotation.

11. Indication device according to claim 9, where the scale at least in certain areas may be provided with adhesive means suitable to adhere the scale to the surface of the body.

12. Indication device according to any of claims 9 to 11 wherein the base is flexible and may be deformed to fit closely to the foot wear, and where the indication pin is rigid.