RU2177762C1 - Method and device for treating foot deformities and lower extremity traumas - Google Patents

Abstract

FIELD: medicine; medical engineering. SUBSTANCE: method involves applying mechanical skin treatment of ventral surface of feet and articulations. Electromyographic examination is carried out before beginning the treatment for determining functional state of shin and foot muscles. Then insole having cylindrical protrusions with hemispheric surface at the top is used to carry out the treatment. Electromyographic examination is periodically carried out. The area subjected to block protrusion action is determined from increased bioelectric activity of shin and foot muscles. It makes 70-90% when compared to the initial value. Time required for wearing the insole is determined from stable increase in electromyographic values by 40-50% relative to the initial level. The insole has bearing base having members fixed thereon. The base is labeled corresponding to boot size. Cylindrical openings are spaced over the whole surface of the bearing base, their diameter being equal to protrusion base dimensions placed on separate plate members. The protrusions have cylindrical shape with hemispheric surface at the top. They fit easily into the base openings from the side adjacent to boot sole. EFFECT: enhanced effectiveness of treatment; reduced risk of postoperative complications. 3 cl, 3 dwg

Description

 The invention relates to medicine and medical equipment, namely to traumatology and orthopedics and to traumatological and orthopedic devices, and can be used to treat patients with congenital clubfoot, flatfoot, other deformities of the feet, osteochondropathies and fractures of bones of the lower extremities.

 Known methods for the correction of foot deformities and treatment of lower limb fractures using soft tissue and plaster bandages, arch support of various designs (A. F. Krasnov, G. P. Kotelnikov, K. A. Ivanova. Orthopedics. M., Med., 1998).

 The main disadvantage of their long-term use is the progressive weakening of skeletal muscle function, their hypotrophy and a decrease in physiological tone. At the same time, the listed devices for correcting foot deformities do not provide for the implementation of the principle of biological feedback, which does not allow the body to independently control the adequate position of the affected segment of the lower limb.

 The deformation of the feet can also be corrected by normalizing the functional characteristics (mass, tone, strength) of the muscles of the lower extremities. The goal is achieved by focused training of these muscles with the help of special exercises of therapeutic gymnastics (V.V. Gorinevskaya, 1953, V.M. Bogolyubov, etc. 1985). Significant disadvantages of the method are the duration of the course of treatment and the need for the participation of a qualified methodologist. In addition, exercises in therapeutic gymnastics must be carried out under close monitoring of the patient’s consciousness. The elimination of this factor at the end of classes leads to a sharp decrease in the achieved effect.

 The normalization of the functional characteristics of skeletal muscles is also achieved by the use of physiotherapeutic stimulation, for example, rhythmic galvanization (L. Nikolova and others. Special physiotherapy. - Sofia, 1974. - S. 373).

 This method is taken as a prototype of the invention.

 Its disadvantages include technical complexity, the need for special equipment and trained personnel. Not all patients tolerate the galvanization process well due to unpleasant sensations caused by exposure to electric current. The technique is contraindicated in a number of somatic diseases.

 The main disadvantage is the lack of biological feedback between the acting device and the patient’s body and, as a result, the impossibility of establishing a conditioned-reflex dependence aimed at maintaining proper posture or an adequate position of the affected limb segment at the end of the exposure.

 Known fixing dressings from hardening materials (gypsum, polymers), orthopedic shoes (A. F. Krasnov, G. P. Kotelnikov, K. A. Ivanova. Orthopedics. - M. Med., 1998) of various designs used to correct deformations feet and treatment of patients with fractures and osteochondropathy of the bones of the lower extremities. The main disadvantage of their prolonged use is the progressive weakening of the function of the muscles of the lower extremities, their hypotrophy and a decrease in physiological tone. The bandages are mostly bulky, for their proper application requires qualified personnel and specially equipped cabinets. Orthopedic footwear does not have functional and dimensional universality, for its production it takes a long time, special production (prosthetic and orthopedic enterprises). And shoes and dressings, as a rule, are inconvenient to use and poorly tolerated by patients. At the same time, the listed devices do not provide for the implementation of the principle of biological feedback, which does not allow the body to independently control the correct position of the departments of the lower limb and provide an adequate load on it.

 For continuous monitoring of the dosed load on the lower limb during fractures and osteochondropathies, the subjective sensations of the patient are used mainly, fixed in his mind at an acceptable level of load.

 Orthopedic insoles of various designs are also used to treat lower limb pathology. Closest to the proposed device is a universal insole (RF Patent 202529). It consists of a set of elements of various configurations, made with the possibility of changing the height. Elements are fixed on the supporting layer of the insole adjacent to the shoe. The number and arrangement of elements are selected depending on the existing pathology.

 This device is taken as a prototype of the invention.

 Its disadvantages include the complexity of individual selection, the lack of dimensional universality, a limited circle of curable pathology. With prolonged use, the insole takes on part of the function of the muscles of the lower leg and foot, so along with the development of a stereotype of the correct position of the lower limb, its muscles are weakened. The main drawback is the lack of biological feedback between the insole and the patient’s body, and as a result, the impossibility of establishing a conditioned reflex relationship aimed at maintaining the correct position of the limb segment or lower limb as a whole.

 The aim of the present invention is to optimize the results of treatment of patients with diseases and injuries of the lower extremities by providing a metered load on the lower limb and its departments or improving the functional characteristics of the muscles of the leg and foot using their selective stimulation. Another goal is to create a device to provide a metered load on the lower limb and its departments or to improve the functional characteristics of the muscles of the leg and foot using their selective stimulation. In both cases, a biological feedback is established between the proposed device and the patient’s body and the formation of conditioned reflex dependence, aimed at maintaining the desired position of the affected lower limb.

 The essence of the proposed method consists in a mechanical effect on the ventral surface of the foot, and before the start of the exposure, an electromyography is performed to determine the initial functional state of the muscles, after which it is exposed to a universal stimulating insole and an electromyography is performed during the action, it is believed that the increase in bioelectric activity of the muscles is 70- 90% of the initial level indicates the occurrence of biological feedback, with the help of which the optimal place is determined the effects of the insole elements and the period of its wearing, at the end of which electromyography is again carried out, the increase of which is by 40-50% from the initial level allows us to establish the occurrence of a conditioned reflex aimed at maintaining the given position of the affected lower limb.

 The essence of the proposed device lies in the fact that it consists of a plastic support base, on which the acting stimulating elements are fixed. The latter are made of a polymeric material and have the form of plate blocks with cylindrical protrusions.

 The stimulating insole (Fig. 1) consists of a support base (1) made of plastic (for example, high pressure polyethylene). The support base has a thickness of at least 1 mm, it is marked with dimensional marking (2), which allows for individual adjustment of the insole to the size of the shoes at home. Throughout the entire area of the support base, cylindrical holes of equal diameter (3) are uniformly made for fastening stimulating elements (4, 5) having a plate shape. On the stimulating elements there are cylindrical protrusions (6) with a hemispherical surface of the apex, the diameter of the base of these protrusions being equal to the diameter of the holes in the support base. Distinguish elements that are highly stimulating (4) - with a smaller diameter of the tips of the protrusions and low-stimulating (5) - with a large diameter of the tips of the protrusions (for example, 1 mm and 2 mm, respectively). Elements are made of the same material as the support base. When the protrusions of the stimulating elements enter the holes of the base from the side adjacent to the shoe, they are fixed (7, side view), and the protrusions are on the side of the insole adjacent to the ventral surface of the foot. The number, type and location zones of stimulating elements are selected depending on the pathology being treated.

 The method using the device is as follows.

 A patient with an established diagnosis is subjected to electromyography of muscle groups of the lower extremity, selected depending on the specific disease. After that, the stimulating elements (4, 5) are placed on the support base (1) in the required quantity, the desired type and in the required zones. After fixing the device, repeat the electromyography. Under the control of the frequency and amplitude of the biopotentials, the stimulating elements of the insole are selected until biological feedback is established, which is expressed in the optimal tension of the stimulated muscles. This is confirmed by an increase in electromyography by 70-90% compared to the original. This mode was chosen because with an increase in the bioelectric activity of the muscles of the leg and foot by more than 90% compared with the initial one, the patient feels discomfort, and when it is increased by less than 70%, the level of muscle stimulation is insufficient. Also determine the time of wearing the insole and the timing of treatment of the patient. During the treatment period, an intermediate electromyography is performed to correct the effect, the need for which is caused by a change in the treatment objectives (increase or decrease in the level of stimulation; change in the groups of stimulated muscles; adaptation of the patient's body). At the end of the treatment period, a control electromyography is performed. A persistent increase in bioelectric activity of muscles by 40-50% confirms the occurrence of a conditioned reflex aimed at maintaining the correct position of the lower limb or its segment.

 To ensure a metered load on the lower limb or on a given area of the foot, the stimulating elements (4, 5) are fixed in the supporting zones or in a specific area of the foot. After that, the limb on the insole is mounted on the scales (A.F. Krasnov, G.P. Kotelnikov, S.N. Izmalkov, 1994) and the maximum load (in kilograms), which causes discomfort in the patient, is measured. Then carry out the selection of stimulating elements of the insole to optimize the load.

 The focus on creating a conditioned reflex allows you to use the proposed method and device both in the neonatal period, in infancy and childhood, and in the treatment of mentally inadequate patients (for example, with cerebral palsy).

 Example 1. Patient B., 9 years old, turned to the Department of Traumatology, Orthopedics and Outpatient Surgery FPO SamGMU on February 11, 1998. After the examination, the diagnosis was made: flat-valgus deformity of the feet. After the initial electromyography from the muscles of the lower leg and foot, the patient was selected with a universal stimulating insole (Fig. 1), for which the support base (Fig. 1, 1) was cut out according to the marking (Fig. 1, 2) corresponding to the size of the patient’s shoes. After that, stimulating elements (Figs. 1, 4, 5) were fixed on the support base (Fig. 1, 1). The place of fixation of the elements is defined in the projection of the longitudinal arch of the foot along its medial edge. The stimulating elements (Figs. 1, 4, 5) are fixed in the holes (Figs. 1, 3) of the support base (Figs. 1, 1) so that their protrusions (Figs. 1, 6) are on the side of the insole adjacent to ventral surface of the foot. A selection was made of the number and type of stimulating elements, which was found to be satisfactory with an increase in the bioelectric activity of muscles by 91%. The constant wearing of the insole while walking is recommended. The duration of treatment was 14 months. During the treatment period, correction of the stimulating elements of the insole was carried out. The effectiveness of the treatment is confirmed by the results of electromyography before treatment, during treatment and upon completion (Fig. 2) and radiography data. The patient is removed from the register with a diagnosis of orthopedic healthy. Comprehensive prophylactic recommendations are given: a course massage of the feet and legs, physical therapy aimed at strengthening the longitudinal arch of the foot, the criteria for the proper selection of shoes are explained. During the follow-up examination of the patient in February 2000, the condition has not changed, is active, does not show complaints.

 Example 2. Patient V., 8 years old, turned to the Department of Traumatology, Orthopedics and Outpatient Surgery FPO SamGMU on September 15, 1997. After the examination, the diagnosis was made: Legg-Calve-Perthes disease on the right. To ensure a metered load on the right lower limb while walking with crutches, the patient was selected with a universal stimulating insole (Fig. 1), for which the support base (Fig. 1, 1) was cut according to the marking (Fig. 1, 2) corresponding to the size of the shoe the patient. After that, stimulating elements (Figs. 1, 4, 5) were fixed on the support base (Fig. 1, 1). The stimulating elements (Figs. 1, 4, 5) are fixed in the holes (Figs. 1, 3) of the support base (Figs. 1, 1) so that their protrusions (Figs. 1, 6) are on the side of the insole adjacent to ventral surface of the foot. The place of fixation of the elements is determined in the projection of the physiological supporting zones of the foot: along its lateral edge, in the heel region, in the projection of the metatarsophalangeal joints. A selection was made of the quantity and type of stimulating elements. To do this, the limb on the insole was mounted on the scales, the maximum value of the load on the limb (in kilograms) was measured, which caused the patient discomfort. The number and type of stimulating elements were selected, which was found to be satisfactory when the patient appeared discomfort at a load level of 2 kg. The constant wearing of the insole when walking on crutches is recommended. The duration of treatment was 20 months. During the treatment period, the stimulating elements of the insole were corrected in the direction of increasing the load level to 2.5 kg, up to 2.8 kg, up to 3.4 kg, up to 4 kg, up to 5 kg, up to 7 kg, up to 9 kg, up to 12 kg . The effectiveness of treatment is confirmed by x-ray data in dynamics. The patient is removed from the register with a diagnosis of orthopedic healthy. During the follow-up examination of the patient in December 1999, the condition did not change, he was active, did not show complaints, and no radiological pathology of the hip joints was revealed.

 Example 3. Patient Z., 5 years old, turned to the department of traumatology, orthopedics and outpatient surgery of the FPO SamGMU on March 17, 1998. After the examination, the diagnosis was made: Congenital right-sided clubfoot. After the initial electromyography from the muscles of the lower leg and foot, the patient was selected with a universal stimulating insole (Fig. 1), for which the support base (Fig. 1, 1) was cut out according to the marking (Fig. 1, 2) corresponding to the size of the patient’s shoes. After that, stimulating elements (Figs. 1, 4, 5) were fixed on the support base (Fig. 1, 1). The place of fixation of the elements is defined in the projection of the lateral edge of the foot in the zone V of the metatarsal bone and V of the toe. The stimulating elements (Figs. 1, 4, 5) are fixed in the holes (Figs. 1, 3) of the support base (Figs. 1, 1) so that their protrusions (Figs. 1, 6) are on the side of the insole adjacent to ventral surface of the foot. A selection was made of the number and type of stimulating elements, which was found to be satisfactory with an increase in bioelectric activity of muscles by 81%. The constant wearing of the insole while walking is recommended. The duration of treatment was 11 months. During the treatment period, correction of the stimulating elements of the insole was carried out. The effectiveness of the treatment is confirmed by the results of electromyography before treatment, during treatment and upon completion (Fig. 3) and radiography data. The patient was removed from the register with a diagnosis of the condition after conservative treatment of congenital right-sided clubfoot. On examination, the varus and equinus deformity is eliminated, there is a slight residual reduction of the right foot. Comprehensive prophylactic recommendations are given: a course massage of the feet and legs, active and passive physical therapy with hypercorrection of residual deformation, the criteria for the correct selection of shoes are explained. During the follow-up examination of the patient in December 1999, the residual adduction of the foot was completely eliminated, there were no particular complaints.

 Example 4. Patient M., 38 years old, turned to the Department of Traumatology, Orthopedics and Outpatient Surgery FPO SamGMU on April 11, 1997. After the examination, the diagnosis was made: A closed fracture of both bones of the middle third of the left leg with a displacement of fragments. An external fixation apparatus was imposed on the patient, and bone fragments were repositioned. To ensure a metered load on the left lower limb while walking with crutches, the patient was selected with a universal stimulating insole (Fig. 1), for which the support base (Fig. 1, 1) was cut according to the marking (Fig. 1, 2) corresponding to the size of the shoe the patient. After that, stimulating elements (Figs. 1, 4, 5) were fixed on the support base (Fig. 1, 1). The stimulating elements (Figs. 1, 4, 5) are fixed in the holes (Figs. 1, 3) of the support base (Figs. 1, 1) so that their protrusions (Figs. 1, 6) are on the side of the insole adjacent to ventral surface of the foot. The place of fixation of the elements is determined in the projection of the physiological supporting zones of the foot: along its lateral edge, in the heel region, in the projection of the metatarsophalangeal joints. A selection was made of the quantity and type of stimulating elements. To do this, the limb on the insole was mounted on the scales, the maximum value of the load on the limb (in kilograms) was measured, which caused the patient discomfort. The number and type of stimulating elements was selected, which was found to be satisfactory when the patient appeared discomfort at a load level of 6 kg. The constant wearing of the insole when walking on crutches is recommended. The duration of treatment was 4 months. During the treatment period, the stimulating elements of the insole were corrected in the direction of increasing the load level to 7 kg, up to 9 kg, up to 13 kg, up to 14 kg, up to 15 kg, up to 18 kg, up to 24 kg. The effectiveness of treatment is confirmed by x-ray data in dynamics. The patient was removed from the register with a diagnosis of: Consolidated fracture of both bones of the middle third of the left leg. When deregistered, he did not show any particular complaints.

 The proposed method using the proposed device treated on an outpatient basis 47 patients with diseases and injuries of the lower extremities.

 Clinical testing has shown that in the vast majority of cases of outpatient conservative treatment using a universal stimulating insole, good results can be achieved, foot deformities can be eliminated, and the periods of temporary disability of patients with lower limb bones can be optimized.

 The proposed universal stimulating insole is easy to use, has a low cost in production, does not require narrow specialists, is easily used on an outpatient basis, can be used both for treatment and for prevention.

Claims (2)

 1. A method of treating deformities of the feet and injuries of the lower extremities, including a mechanical effect on the skin of the ventral surface of the feet, characterized in that before the start of the exposure, electromyography is performed to determine the initial functional state of the lower leg and foot muscles, after which the insole is made with hemispherical protrusions the top surface and periodically conduct electromyography, and the area of exposure of the protrusions of the blocks is determined by increasing bioelectric activity ty of the leg and foot muscles by 70-90% of the initial one, the period of wearing the insole is determined by the persistent increase in the electromyography indices by 40-50% of the initial level.  2. Insole for the treatment of deformities of the feet and injuries of the lower extremities, consisting of a support base on which elements are fixed, characterized in that a marking corresponding to the size of the shoe is applied to the base, a cylindrical hole with a diameter equal to the size of the base is made over the entire area of the support base protrusions located on separate plate elements, the protrusions having a cylindrical shape with a hemispherical surface of the apex and enter the holes of the base of the insole from the side adjacent to the shoe.

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