Method for control of stepping movements using transcutaneous electrical spinal and muscular stimulation

Abstract

The invention relates to medicine, and more particularly to a novel method for the control of stepping movements in patients with traumatic injuries or diseases of the spinal cord and / or the brain using transcutaneous electrical stimulation, which includes continuously stimulating the spinal cord at the level of the C5-C6, T11-T12 and L1-L2 vertebrae and simultaneously creating a synergistic effect to control foot movement by means of spatial-temporal stimulation of the flexor and extensor muscles of the lower leg in the corresponding phases of the gait cycle. This combined spinal and muscular stimulation enables a coordinated, complete gait, in which the patient is able to control the stepping movements, including controlling foot movements.

Description

[0001] METHOD OF CONTROLLING WALKING MOVEMENTS BY MEANS OF TRANSCUTANEOUS ELECTRICAL SPINAL-MUSCLE STIMULATION.

[0002] Field of technology to which the invention relates

[0003] The invention relates to the field of medicine, in particular to neurophysiology, and can be used in neurology, traumatology and orthopedics in the rehabilitation of patients after diseases and / or traumatic injuries to the brain and / or spinal cord, the consequence of which is a violation of walking function.

[0004] Prerequisites for the creation of the invention

[0005] Spinal cord injuries (SCI) occur as a result of falls from height, motor vehicle accidents, sports activities, and other causes. The severity of SCI-related impairments depends on the extent of the spinal cord injury and the location of the injury within the spinal cord. SCI results in complete or partial loss of sensory and / or motor functions below the level of injury. In paraplegia of the lower extremities, arm function is preserved; in tetraplegia, arm function is impaired. SCI negatively impacts the ability to perform daily activities, including walking.

[0006] At the current stage of scientific and technological development, transcutaneous electrical spinal cord stimulation (TESS) is used in clinical practice. TESS is used for gait rehabilitation in patients with incomplete spinal cord injury (ASIA C, D according to the American Spinal Injury Association classification) [1, 2]. In case of paralysis of leg movements (complete paraplegia, ASIA A, B), such stimulation ensures independent standing [3], voluntary leg movements in an unsupported position (lying on the back or on the side) [4], and walking with assistance that ensures forward movement [5]. Patients with SCI undergoing TESS are unable to fully push the body forward at the end of the support phase, which depends on the activity of the muscles of the back of the lower leg, as a result of which independent walking is difficult.Furthermore, the lack of activity in the anterior calf muscles leads to dragging of the feet during the swing phase, resulting in stumbling, which can lead to a fall. For these reasons, it is impossible to reproduce a correct, full, and high-quality step during electrical spinal cord stimulation in patients with complete paraplegia due to SCI.

[0007] TSCS activates muscle groups rather than individual muscles. Following complete spinal cord injury, the lack of motor activity leads to muscle atrophy. Within a few months after SCI, muscles lose their excitability. When using standard commercial electrical stimulators [6], these muscles may not respond to TSCS. In such cases, targeted activation of the muscles necessary for initiating and activating propulsion is necessary.

[0008] Leg muscle activity in all phases and episodes of the step is known from numerous studies [7]. The possibility of using TSCS to activate leg muscles has been proven [8, 9]. The possibility of activating leg muscles using TSCS depending on the step phases on the stimulation side is also known

[0010] and is used to rehabilitate independent walking in patients with hemiparesis due to acute cerebrovascular accident (stroke)

[0011] . The latter method increases the stability of the affected leg during the stance phase and improves the quality of the swing phase of the uninjured leg during stance. However, this method cannot be used to activate body propulsion during the stance phase in patients with TOM due to paraplegia.

[0009] Research has been conducted on the use of programmable myostimulation in cyclic sports to improve athletic performance through selective activation of the leg muscles during specific phases of the gait cycle. Another method of stimulating the musculoskeletal system is functional electrical stimulation (FES), used to artificially correct motor stereotypes during walking. FES is performed during the patient's motor activity (passive, active movements, mechanotherapy) and provides stimulation of the motor nerve or muscle during the phase of movement when the muscle is active during natural voluntary movement

[0012] . The motor effects of TSCS and FES are combined

[0013] .

[0010] However, none of the known methods allows for full control of the movement of patients with SCI, which ensures the patient's upright posture (standing) and all phases of walking, when the patient has the ability to control the movement of the foot.

[0011] Thus, there is a need to develop a new method (technique) for controlling locomotor function. This is the focus of this application.

[0012] The essence of the invention

[0013] The technical problem addressed by the present invention is the cyclic activation of leg muscles by electrical stimulation of the spinal cord and the provision of body propulsion and transfer of the right and left legs by direct stimulation of the calf muscles in the corresponding phases of the walking cycle to achieve independent walking in patients with SCI.

[0014] The technical result, which the proposed technical solution is aimed at, is the development of stimulating effects on the structures of the spinal cord and the muscles of the lower leg to control the structure of stepping movements.

[0015] The technical result of the claimed invention is achieved by using transcutaneous electrical stimulation to control walking movements in patients with traumatic injuries and / or diseases of the spinal cord and / or brain. This method involves simultaneously applying continuous spinal cord stimulation at the C5-C6, T11-T12, and L1-L2 vertebrae and spatiotemporal stimulation of the flexor and extensor muscles of the lower leg during the corresponding phases of the walking cycle to control foot movement. Furthermore, continuous spinal cord stimulation is initiated and terminated manually.

[0016] In addition, the start and stop of spatiotemporal stimulation of the flexor and extensor muscles of the lower leg is carried out by means of a signal from gyroscopes located above the knee joint of the lower limb.

[0017] In addition, stimulation of the lower leg flexor muscles is carried out in the lower limb transfer phase, and stimulation of the lower leg extensor muscles is carried out in the lower limb support phase.

[0018] In addition, the time interval for stimulating the flexor or extensor muscles of the lower leg is set independently as a percentage of the duration of the gait cycle, starting from the first step.

[0019] Human walking is the movement of the body through space, achieved by shifting the center of mass beyond the support surface. Human walking can be described by the alternating cyclical movements of the right and left legs. The cycle of each step is divided into a support period and a swing period. Each support period includes two episodes of double support, when the feet of both legs are in contact with the support surface. Forward body movement occurs during episodes of double support. Forward movement is achieved by pushing off one leg from the support surface, which occurs through active plantar flexion at the ankle joint [4]. With plantar flexion of the foot, the angle at the ankle joint increases, and the torso (center of mass) moves upward and forward, with the contralateral leg providing support.

[0020] The invention is intended for patients with SCI who:

[0021] - can perform step-like movements with their legs independently or using the TSCS in an unsupported position (lying on their back or on their side),

[0022] - can stand independently, or with the use of technical rehabilitation equipment (crutches, canes, walkers, etc.), or with the use of TECS,

[0023] - standing, they cannot take a step.

[0024] The uniqueness and novelty of the claimed invention lies in the integration of spinal and peripheral motor control mechanisms. Spinal stimulation targets neural locomotor networks, while stimulation of peripheral nerves and / or muscles affects specific motor pools and muscles, regulating the phases (swing and support) of the gait cycle. Combined spinal-muscular stimulation enables coordinated, full-fledged gait, which cannot be achieved with spinal or peripheral stimulation alone.

[0025] Using spinal-peripheral stimulation, which combines continuous stimulation of locomotor neural networks and spatiotemporal stimulation of the flexor or extensor muscles of the lower leg during the gait cycle, it is possible to control human gait, specifically, selectively control foot movement. Thus, the developed method enables the creation of a new movement pattern, enabling the patient to control stepping movements while regulating foot movement. Terms and Definitions

[0026] Definitions of certain terms used in this specification are provided below. Unless otherwise defined, technical and scientific terms in this application have standard meanings generally accepted in the scientific and technical literature.

[0027] In the present description and in the claims, the terms “includes,” “including,” and “includes,” “having,” “provided with,” “containing,” and their other grammatical forms are not intended to be interpreted in an exclusive sense, but, on the contrary, are used in a non-exclusive sense (i.e., in the sense of “having in its composition”). Only expressions of the type “consisting of” should be considered as an exhaustive list.

[0028] By “regulation of walking” or “control of walking” we mean the control of walking characteristics as a whole (speed, step amplitude, duration), and its components, for example, the phases of the walking cycle (transfer, support).

[0029] The term "stimulation" refers to the application of alternating current to the electrical stimulation, where "continuous stimulation" refers to stimulation whose onset and end are independent of the rhythmic movements of the intact (not affected by the pathological process that caused the hemiplegia) arms and legs; "intermittent (rhythmic) stimulation" refers to stimulation whose onset and end are synchronized with the rhythmic movements of the legs; and "spatiotemporal stimulation" refers to stimulation of the calf muscles where the onset and end of this stimulation depend on the phase of the leg movements.

[0030] Examples of diseases of the brain and / or spinal cord that result in impaired walking function include stroke of the brain or spinal cord, degenerative and inflammatory diseases of the brain or spinal cord, and iatrogenic diseases.

[0031] Examples of brain and / or spinal cord injuries include concussion, brain compression, brain contusion, cerebral hemorrhage due to a blow to the head, spinal cord concussion, spinal cord contusion, spinal cord compression, anatomical spinal cord rupture, spinal cord hematomyelia, spinal cord hemothoraxis, injury to a major spinal vessel, and spinal nerve root injury. Following the aforementioned illnesses or injuries, patients may experience impaired motor skills and musculoskeletal function, manifested by limb paresis or paralysis, loss of sensation, and lack of coordination.

[0032] Brief description of the drawings

[0033] The accompanying drawings, which are incorporated into and form a part of this specification, illustrate embodiments of the invention and, together with the above general description of the invention and the following detailed description of embodiments, serve to explain the principles of the present invention. In the drawings, like reference numerals are used to designate like parts or structural elements.

[0034] Fig. 1 shows the diagram of the placement of electrodes for electrical stimulation of the spinal cord and leg muscles. A - posterior view. B - anterior view. C - cathodes; ASC - anodes for multilevel stimulation of the spinal cord; ATA - anode for stimulation of the anterior tibialis muscle (m. tibialis ant.); AMG - anode for stimulation of the gastrocnemius muscle (m. gastrocnemius).

[0035] Fig. 2A shows the trajectory of the marker located on the big toe (the end point trajectory) during walking on a treadmill. A. Green arrows indicate the beginning of the stance phase, red arrows indicate the beginning of the swing phase. B. Green arrows indicate the onset of MG stimulation during the stance phase, red arrows indicate the onset of TA stimulation during the swing phase.

[0036] Fig. 2B shows a diagram for measuring joint angles and linear displacements of anthropometric points. H, Vrt, Vbc, Nbc, Knch are the humeral, trochanteric, upper tibial, lower tibial, and terminal anthropometric points, respectively. 1, 2, 3 are the hip, knee, and ankle joint angles, respectively. X, Z are the sagittal and vertical directions of movement, respectively.

[0037] Fig. 3 shows the structure of the stepping cycle during walking on a treadmill without stimulation (Control), with electrical stimulation of the gastrocnemius muscle of the right leg (MG Stimulation) in the support phase, and with electrical stimulation of the anterior tibialis muscle of the right leg (TA Stimulation) in the swing phase.

[0038] Fig. 4 shows diagrams characterizing the change in the height of the limb lift (foot lift) and the time of limb lift (foot lift time) from the moment of push-off to the maximum point above the support with electrical stimulation of the MG muscles separately and with combined stimulation of the MG and TA of the right leg relative to stepping movements without stimulation (% of the initial condition, 100% - control).

[0039] Fig. 5 shows the trajectories of the end point (the marker is located on the big toe) when walking on a treadmill with different types of stimulation (blue lines) and without stimulation (red lines).

[0040] Designations:

[0041] MG - stimulation of the flexor-extensor muscles of the lower limb (in the presented study, stimulation of the gastrocnemius muscle of the right leg),

[0042] TA - stimulation of the flexor-extensor muscles of the lower limb (in the presented study, stimulation of the anterior tibialis muscle of the right leg),

[0043] SCS - spinal cord stimulation,

[0044] HIP - angular displacements of the hip joint when walking on a treadmill,

[0045] KNEE - angular displacements of the knee joint when walking on a treadmill, ANKLE - angular displacements of the ankle joint when walking on a treadmill.

[0046] Detailed description of the invention

[0047] In general, the present invention relates to the development of a new technology for electrical spinal muscle stimulation to control walking movements, which incorporates elements of neurorehabilitation and motor prosthetics. Continuous spinal cord stimulation activates spinal neural networks and engages mechanisms that generate the walking rhythm and interlimb coordination, while spatiotemporal stimulation determines which muscles should be activated during the walking cycle and at what time to ensure support and limb transfer. The essence of the invention lies in providing stimulation-controlled locomotion in paralyzed patients.

[0048] The present invention proposes to use muscle stimulation. However, nerve stimulation is also possible in cases where patients exhibit muscle atrophy. A significant limitation of the use of peripheral nerve stimulation is the unreliable fixation of the stimulating electrodes in the projection of the nerve. During movement, they tend to shift, and stimulation becomes unstable. Therefore, it is mainly used when the patient is at rest. Thus, peripheral stimulation of the n. tibialis (tibial nerve) activates the extensor muscles (m. gastrocnemius (gastrocnemius muscle) and m. soleus (soleus muscle) and causes plantar flexion of the foot, and stimulation of the n. peroneus (peroneal nerve) activates the flexor muscle (m. tibials ant (anterior tibial muscle)) and causes dorsal flexion of the foot. In the first case, the foot is lowered downwards, in the second case, it is raised upwards.In a preferred embodiment of the invention, stimulation is carried out directly on the muscles of the lower leg, such as the m. tibials ant (anterior tibial muscle) and the m. gastrocnemius (calf muscle).

[0049] The stimulation algorithm is as follows. Initially, continuous transcutaneous electrical stimulation of the spinal cord is applied (manually) at the C5-C6, T11-T12, and L1-L2 vertebrae. The patient then begins stepping movements with the assistance of a physical therapist or independently. If the patient is unable to take the first step independently, the first few steps are taken passively with external assistance. Gyroscopes detect the phases of the stepping cycle.

[0050] During the patient's third step, in the preferred embodiment, a trigger is activated (the gyroscope signal is transmitted to a control unit with embedded software capable of calculating the duration of the stepping cycle and timing muscle stimulation, and controlling the onset of muscle stimulation). The gyroscope, located above the knee joint, detects the swing phase of the lower limb. The duration of the stepping cycle (the time from one swing of the lower limb to the next) is then automatically determined, with 40% of the time allocated to the swing phase and 60% to the stance phase.

[0051] The lower limb swing trigger activates stimulation of the tibialis anterior muscle, which flexes the ankle joint (the foot is lifted upward). Stimulation continues throughout the swing phase. After this phase, stimulation of the flexor muscles is turned off and stimulation of the gastrocnemius extensor muscle is activated, which propels the body forward (propulsion) and pushes off the leg during the stance phase. Stimulation of the leg flexor and extensor muscles is then repeated according to the algorithm described above.

[0052] Transcutaneous electrical stimulation of the spinal cord and muscles is implemented using monopolar rectangular pulses or bipolar rectangular pulses with a current amplitude of 1 to 200 mA and a modulation frequency in the range of 5 kHz to 10 kHz.

[0053] In preferred embodiments of the invention, the current amplitude does not exceed 100 mA, since it is intended to use spinal cord stimulation on patients with intact sensitivity.

[0054] The stimulation current intensity is prescribed by a specialist / physician, but can be adjusted by the patient within a limited range. Current intensity is individually selected based on the patient's excitability, motor response threshold, and pain sensitivity.

[0055] The frequency of transcutaneous electrical stimulation is in the range of 1-99 Hz.

[0056] Stimulation of the ipsilateral limb is known to affect the contralateral limb. When using spatiotemporal FSFM on one limb, the bilateral effect produces similar, but less pronounced, changes in movement in the contralateral limb

[0015] . In clinical studies of stroke patients, stimulation of the affected limb has been shown to improve movement not only in the paretic limb but also in the relatively healthy leg. These results suggest that stimulation of only one (ipsilateral) limb is appropriate for healthy subjects and stroke patients, while stimulation of both limbs is necessary for patients with SCI.

[0057] Below is a detailed description of the method for controlling the patient's walking movements.

[0058] The study was conducted at the Research Institute of Sports Problems and Health-Related Physical Culture of the Velikiye Luki State Academy of Physical Culture and Sports (VLGAFK) using 8 healthy volunteers. All subjects were male, with an average age of 25 years.

[0059] Procedure. During all stages of the study, subjects walked on a treadmill (h / p / cosmos gaitway®) at a speed of 1.5 km / h. The study consisted of eight consecutive stages, each lasting approximately 1–1.5 min (Table 1). The first stage—walking without stimulation—served as a control stage. In the seven subsequent stages, multilevel electrical stimulation of the spinal cord and / or lower extremity muscles was administered on the right side (in this study, stimulation was not performed on the left side). During the stimulation stages, subjects walked without stimulation for the first 30 seconds, then stimulation began.

[0060] Table 1. Study protocol.

[0061] Electrical stimulation

[0062] To stimulate the spinal cord, three cathodes (0 3 cm) were attached to the skin at three levels: between the C5-C6, T11-T12, and L1-L2 vertebrae (Figure 1, A). The electrodes were placed along the midline of the spine. Two common anodes (5 x 10 cm) 2 ) were placed symmetrically on the skin above the iliac crests (Figure 1, B). Stimulation was performed continuously with bipolar rectangular pulses at a frequency of 40 Hz at the C5-C6 level, at a frequency of 30 Hz at the T11-T12 level, and at a frequency of 15 Hz at the L1-L2 level, in accordance with the results of previous studies showing that this combination of stimulating effects is the most effective in regulating stepping movements.

[0063] The stimulation frequency at the T11-T12 and L1-L2 vertebral levels was selected in accordance with previous studies that determined the "stimulation frequency - muscle response magnitude" relationships for different levels of spinal cord stimulation

[0019] . Those stimulation frequencies were selected that elicit the maximum muscle response. For stimulation at the C5-C6 vertebral level, a frequency was chosen that, in previous studies, yielded a good rehabilitation effect [5, 6, etc.]. Bipolar pulses with a duration of 1 ms were filled with a carrier frequency of 5 kHz.

[0064] To stimulate the right anterior tibialis muscle (m. tibialis ant.), the cathode (0 3 cm) was placed in the wide part of the muscle, below the lateral condyle of the tibia, the anode - in the lower third of the shin, above the transition of the muscle to the tendon (Figure 1, B). Stimulation was performed with monopolar rectangular pulses of 1 ms duration, following at a frequency of 35 Hz, filled with a carrier frequency of 5 kHz. The beginning and end of stimulation depended on the step phases of the left leg. To stimulate the right gastrocnemius muscle (m. gastrocnemius), the cathode (0 3 cm) was placed in the wide part of the muscle, between the medial and lateral heads of the muscle, the anode - above the Achilles tendon (Figure 1, A). Stimulation was performed with monopolar rectangular pulses of 1 msec duration, occurring at a frequency of 35 Hz and filled with a carrier frequency of 5 kHz. The onset and end of stimulation depended on the phases of the left leg's step.

[0065] The intensity of spinal cord and muscle stimulation was individually adjusted for each subject while they walked on a treadmill after the first stage of the study. The stimulation intensity was set to ensure that the subject could feel the stimulation but did not experience pain or discomfort.

[0066] Controlling the start and end of muscle stimulation

[0067] To determine the phases of a walking stride, sensors including an electronic gyroscope and accelerometer were used. Based on the sensor readings, an estimate of the angle of the sensor's measuring axis with the vertical is constructed. The estimation algorithm consists of integrating the gyroscope signals with correction based on the accelerometer signals.

[0068] The sensor was placed on the anterior thigh above the subject's right knee. During walking, the angle of the sensor's measuring axis with the vertical in the sagittal plane was analyzed. The moment of leg lift—the beginning of the swing phase—was determined. This event corresponds to the onset of hip flexion—the moment the rate of change in the hip angle with the vertical changes from negative to positive.

[0069] The beginning of a step is considered to be the moment the foot hits the ground. Therefore, the beginning of a step was defined as the moment after the detected moment of the beginning of the foot swing equal to the duration of the swing phase. The duration of the swing phase was assumed to be 40-45% of the duration of the previous gait cycle (the time between the last two moments of the beginning of the foot swing). The step phase detection algorithm was adjusted after the first three steps.

[0070] The stimulation time interval was set independently for each stimulation channel as a specified fraction of the gait cycle. The stimulation start and end times were set as percentages of the gait cycle duration, starting from the start of the step. These specified stimulation start and end percentages were then programmatically rounded to whole sixteenths of the gait cycle duration. Thus, the stimulation start and end times, T1 and T2, respectively, were set as follows:

[0071] T1 = T0 + n1 * T / 16

[0072] T2 = TO + n2 * T / 16, where TO is the start time of the step, T is the duration of the last walking cycle, n1 and n2 are integers in the range from 0 to 15.

[0073] TO and T were values ​​determined from the readings of the sensor on the right leg.

[0074] Stimulation of the gastrocnemius muscle occurred during 60-65% of the right leg's stance phase step cycle. Stimulation of the tibialis anterior muscle occurred during 40-45% and 50% of the right leg's swing phase step cycle (Fig. 2A (B)).

[0075] Registration of kinematic characteristics of walking To register the kinematics of leg movements, the Qualisys 3D video motion capture system was used.

[0076] The system included eight high-speed Oqus cameras positioned around the perimeter of the treadmill. The video capture rate was 500 Hz. Reflective markers were attached to the right side of the body to points aligned with the axes of motion at the shoulder, hip, knee, and ankle joints, allowing for the calculation of angular and linear movements of the right leg joints (Figure 2B).

[0077] Additionally, to evaluate the spatiotemporal and kinematic parameters of gait, Neurosens sensors were used, which were part of the Steadis system with the supplied software (manufacturer: Neurosoft LLC, Russia). The recording frame rate was 200 Hz. Seven Neurosens sensors were used, which were installed in the following order: 1 / 2 - left / right feet; 3 / 4 - lateral malleoli of the left / right leg; 5 / 6 - lateral surface of the left / right thigh; 7 - installed on the coccyx.

[0078] RESULTS

[0079] Figure 3 shows the structure of the stepping cycle during treadmill walking without stimulation (control), with MG stimulation during the stance phase, and with TA stimulation during the swing phase (see Figure 2). The change in the structure of the stepping cycle demonstrates that MG stimulation causes body propulsion due to additional knee extension and foot push-off from the treadmill surface, followed by limb lift. This is clearly evident in the endpoint trajectory (Figure 3). According to the kinematics of the movement, TA stimulation during the stance phase results in additional (relative to control) knee flexion and pronounced dorsiflexion of the foot (Figure 3).

[0080] Statistical analysis of movement parameters performed for all subjects revealed that MG stimulation increased foot ascent after propulsion by 150% relative to the control group (Figure 4). TA stimulation did not increase foot ascent (Table 2), but examination of the endpoint trajectory revealed variable changes in the movement pattern (Figure 3). MG stimulation revealed changes in the foot ascent phase from toe-off to the maximum point, indicating a more efficient propulsion phase during gait, while the swing phase remained unchanged from the control group (Figure 3, MG Stimulation). In turn, stimulation of the TA directly influences the transfer phase, in which it is clearly visible that the foot moves more horizontally over the support and before placing the foot on the support, the toe rises higher than when walking without stimulation (Figure 3, Stimulation of the TA), which can lead to a decrease in foot dragging in case of impaired motor functions of the lower extremities.

[0081] The effects of combined spinal cord stimulation and stimulation of the MG and TA muscles are shown in Figure 5. It is evident that the trajectory of the end point movements with MG, TA, and MG+TA stimulation (blue lines) differs significantly from the trajectory of the end point movements during walking without stimulation (red line). With combined spinal cord and muscle stimulation, these effects are more pronounced (Figure 5, right column). Table 2 presents (average data for eight subjects) the angular displacements of the hip, knee, and ankle joints, the height of the instep, and the area of ​​the reciprocal HIP / KNEE and KNEE / ANKLE goniograms of the right leg during treadmill walking (according to Steadis data).

[0082] Table 2. Kinematic parameters of the right limb movement during walking without stimulation (control) and under different stimulation conditions.

[0083] All comparative data presented below are made relative to the indicators recorded during walking without stimulation (control).

[0084] MG stimulation

[0085] Increases the range of motion of the right leg at the knee by 3.2%, at the ankle by 45.7%, and the height of the right foot instep by 13.9% compared to values ​​recorded during walking without stimulation. The length of the movement trajectory increases (i.e., the area described by the coordinates at the knee and ankle joints increased by 28%). At the same time, the duration of support decreases by 9.2%, and the swing time increases by 8.4%.

[0086] Stimulation of MG+ C5-C6, T11-T12, L1-L2

[0087] Changes the range of motion compared to the range of motion before stimulation in all three joints of the right leg. The hip angle increases by 9.5%, the knee angle by 10.9%, and the ankle angle by 20.3%. The height of the instep increases by 19.8%. The area described by the coordinates in the knee and ankle joints increases by 26.9%. Meanwhile, the duration of foot support decreases by 7.9%, and the swing duration by 8.3%.

[0088] TA stimulation

[0089] No significant changes were observed in the range of motion in the joints or the height of the right foot instep compared to pre-stimulation. The height of the right foot instep remains unchanged.

[0090] Stimulation of TA+ C5-C6, T11-T12, L1-L2

[0091] Only the hip angle significantly changes—it increases by 6% in the right leg. The right leg lift remains unchanged.

[0092] MG+TA stimulation

[0093] The ankle angle of the right leg significantly increased by 41.2%. In other joints, the increase was 5.3% (hip) and 7.8% (knee). The instep height significantly increased by 17%. The stance duration of the right leg decreased by 4%.

[0094] Stimulation of MG+TA+ C5-C6, T11-T12, L1-L2

[0095] Changes the range of motion of the right leg compared to the range of motion before stimulation in all three joints: in the hip joint - by 11.4%, in the knee joint - by 7.1%, in the ankle joint - by 19.4%. The height of the instep increases by 16%.

[0096] Conclusion

[0097] Results from studies conducted on healthy volunteers demonstrate that spinal muscular stimulation is an effective method for regulating human locomotion. It has been proven that spinal muscular stimulation regulates stepping parameters more effectively than spinal or muscular stimulation alone.

[0098] Although the invention has been described with reference to the disclosed embodiments, it will be apparent to those skilled in the art that the specific studies described in detail are provided merely for the purpose of illustrating the present invention and should not be construed as limiting the scope of the invention in any way. It will be understood that various modifications can be made without departing from the spirit of the present invention. References

[0099] 1. Moshonkina TR [et al.]. Transcutaneous electrical stimulation of the spinal cord in motor rehabilitation of patients with spinal cord injury. Integrative Physiology. 2020. No. 4 (1). P. 350-364.

[0100] 2. Megia Garcia A. [et al.]. Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review / / Neurorehabilitation and Neural Repair. 2020. No. 1 (34). C. 3-12.

[0101] 3. Sayenko DG [and others]. Self-Assisted Standing Enabled by Non-invasive Spinal Stimulation after Spinal Cord Injury Journal of Neurotrauma. 2019. (36). pp. 1435-1450.

[0102] 4. Gerasimenko YP [etc.]. Noninvasive Reactivation of Motor Descending Control after Paralysis / / Journal of Neurotrauma. 2015. No. 24 (32). C. 1968-1980.

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Claims

Formula [Item 1] A method for controlling walking movements in patients with traumatic injuries and / or diseases of the spinal cord and / or brain using transcutaneous electrical stimulation, including simultaneous - continuous stimulation of the spinal cord at the level of the C5-C6, T11-T12 and L1-L2 vertebrae - and spatiotemporal stimulation of the flexor and extensor muscles of the lower leg in the corresponding phases of the stepping cycle to control the movement of the foot, carried out by placing electrodes on the flexor and extensor muscles of the lower leg. [Item 2] The method according to item 1, characterized in that the start and stop of continuous stimulation of the spinal cord is carried out manually. [Item 3] The method according to item 1, characterized in that the start and stop of spatiotemporal stimulation of the flexor and extensor muscles of the lower leg is carried out by means of a signal from gyroscopes located above the knee joint of the lower limb. [Item 4] The method according to item 3, characterized in that stimulation of the leg flexor muscles is carried out in the phase of transfer of the lower limb, and stimulation of the leg extensor muscles is carried out in the phase of support of the lower limb. [Item 5] The method according to item 4, characterized in that the time interval for stimulating the flexor or extensor muscles of the lower leg is set independently as a percentage of the duration of the walking cycle, starting from the first step.

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