Acupuncture point electrical stimulation lower limb rehabilitation equipment and use method thereof

Abstract

The invention discloses acupoint electrical stimulation lower limb rehabilitation equipment and a using method thereof, and belongs to the technical field of rehabilitation equipment, the acupoint electrical stimulation lower limb rehabilitation equipment comprises an auxiliary foot dorsal movement device, and the auxiliary foot dorsal movement device comprises a leg supporting frame and a foot supporting frame hinged to the lower end of the leg supporting frame; the foot dorsum auxiliary movement device further comprises a driving device which is electrically connected to the control processing terminal. A sensing module is arranged on the foot dorsum auxiliary movement device and comprises a first inertial measurement unit and a second inertial measurement unit; the leg supporting frame comprises an inner supporting plate and an outer supporting plate, an electrical stimulation electrode is arranged on the leg supporting frame and comprises a yin meridian acupoint electrode and a yang meridian acupoint electrode, and the yin meridian acupoint electrode and the yang meridian acupoint electrode are both electrically connected to the control processing terminal. Active, passive and electrical stimulation can be combined, and the optimal effect of rehabilitation training is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of rehabilitation equipment, and in particular to an acupoint electrical stimulation lower limb rehabilitation equipment and a use method thereof. Background Art

[0002] Walking disorder is one of the most common functional disorders in hemiplegic patients and has the greatest impact on daily life. Walking disorder is mostly caused by ankle dorsiflexion dysfunction, and dorsiflexion movement has a great impact on gait.

[0003] Transcutaneous electrical acupoint stimulation combines the principles of transcutaneous electrical nerve stimulation and the meridian theory of traditional Chinese medicine. It can relieve pain and reduce the degree of limb spasm. At the same time, it transmits the deep and shallow sensory information impulses of the skin to the central nervous system, thereby promoting the functional reorganization and plasticity changes of the central nervous system. Studies have found that transcutaneous electrical acupoint stimulation therapy has a short-term effect. The effect after stimulation will gradually decrease over time. Even the duration of strong stimulation is limited, and active rehabilitation training is also required to maintain the continuity of the rehabilitation effect. At the same time, a reasonable and complete rehabilitation program for acupoint (electrical) stimulation of traditional Chinese medicine should include both active and passive treatments, and the short-term effect of acupoint stimulation can help active exercise therapy and improve the efficiency of rehabilitation training. On the other hand, the excitability of the cerebral cortex to repeated active movements cannot be maintained at the same high level for a long time. After a long period of single repetitive exercise training, patients are prone to adapt to the movement pattern, and the cerebral cortex reduces its excitability, which is not conducive to the reconstruction of motor function. Conversely, it is necessary to add external stimulation to exercise training to maintain the excitability of the cerebral cortex, because both can promote muscle contraction rehabilitation training, and their effects are complementary to a certain extent.

[0004] In practice, many hemiplegic patients still find it difficult to complete the rehabilitation training process relying solely on electrical stimulation and active consciousness, and they also need the support of passive movement. However, there is currently no lower limb rehabilitation equipment on the market that can combine active, passive and electrical stimulation. This comprehensive solution is of great significance to improving rehabilitation effects, so there is an urgent need for it. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide an acupoint electrical stimulation lower limb rehabilitation device which can combine active, passive and electrical stimulation.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0007] On the one hand, the present invention provides an acupoint electrical stimulation lower limb rehabilitation device, comprising a dorsal foot auxiliary exercise device, the dorsal foot auxiliary exercise device comprising a leg support frame for fixing to a human calf and a foot support frame hinged at the lower end of the leg support frame for fixing to a human foot and capable of driving the foot to exercise;

[0008] The instep auxiliary exercise device also includes a driving device for driving the foot support frame to rotate around the hinge of the leg support frame and the foot support frame to drive the foot to move, and the driving device is electrically connected to the control processing terminal;

[0009] The instep auxiliary exercise device is provided with a sensor module, and the sensor module includes a first inertial measurement unit located on the upper part of the leg support frame for measuring the movement state of the calf and a second inertial measurement unit located on the foot support frame for measuring the movement state of the foot;

[0010] The leg support frame includes an inner support plate for being placed on the inner side of the calf and an outer support plate for being placed on the outer side of the calf. The leg support frame is provided with electrical stimulation electrodes, and the electrical stimulation electrodes include Yin meridian acupoint electrodes located at the lower part of the inner support plate for stimulating Yin meridian acupoints and Yang meridian acupoint electrodes located at the upper part of the outer support plate for stimulating Yang meridian acupoints. The Yin meridian acupoint electrodes and the Yang meridian acupoint electrodes are both electrically connected to the control processing terminal.

[0011] Further, the second inertial measurement unit is located below the hinge of the leg support frame and the foot support frame, and the first inertial measurement unit and the second inertial measurement unit are both located on the outside of the calf parallel to the force line direction of the lower limb;

[0012] And / or, the hinge axis of the leg support frame and the foot support frame is based on the inframalar joint surface under the medial malleolus and the protectively supported lateral malleolus as the axis.

[0013] Further, the Yin meridian acupoint electrode includes a first electrode for attaching to the Sanyinjiao acupoint and a second electrode for attaching to the Zhaohai acupoint, and the Yang meridian acupoint electrode includes a third electrode for attaching to the Zusanli acupoint and a fourth electrode for attaching to the Yanglingquan acupoint;

[0014] And / or, the upper front of the inner support plate and the outer support plate are integrally provided with a front arc-shaped connecting portion;

[0015] and / or, binding fabrics are provided at the upper rear of the inner and outer support plates;

[0016] And / or, binding fabrics are provided at the front of the lower parts of the inner supporting plates and the outer supporting plates.

[0017] Furthermore, the foot support frame includes a U-shaped connector extending backward and downward from the hinge to wrap around the heel, a pair of wing plates extending forward and downward from the hinge to be attached to the instep, and an instep fixing member located at the front end of the pair of wing plates.

[0018] Further, the driving device includes a support rod and a transmission device electrically connected to the control processing terminal for driving the support rod to move up and down, the transmission device is located at the upper end of the support rod, and the lower end of the support rod is drivingly connected to the U-shaped connecting piece; a rear arc-shaped connecting part is integrally provided at the rear of the lower part of the inner support plate and the outer support plate, and the transmission device is fixed on the rear arc-shaped connecting part;

[0019] and / or, the driving device is provided with a force sensor for detecting the driving force of the foot support frame;

[0020] And / or, the number of the instep auxiliary exercise devices is two and they share one control processing terminal;

[0021] And / or, the transmission device is a Bowden cable transmission device, and the control processing terminal includes a processor, and the processor is connected to an adjustment button, a display, and a rope drive control system for controlling the transmission device.

[0022] In another aspect, the present invention provides a method for performing rehabilitation training using the above-mentioned acupoint electrical stimulation lower limb rehabilitation device, comprising:

[0023] Step S101: Obtain the patient's initial force F initial and the total force F recommended for the patient total , wherein the F initial After the patient wears the acupoint electrical stimulation lower limb rehabilitation device on the affected leg, the force sensor measures the F total The force is measured by the force sensor when a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0024] Step S102: The F initial and F total Input the pre-trained neural network model to obtain the acupoint electrical stimulation force F required by the patient e and mechanical force F mech , wherein the F initial 、F total 、F e and F mech Satisfy formula F total =F initial +F e +F mech ;

[0025] Step S103: According to the F e and F mech The acupoint electrical stimulation lower limb rehabilitation equipment is controlled to perform rehabilitation training on the patient.

[0026] Furthermore, the step S101 includes:

[0027] Acquiring the patient's stride length and frequency information, wherein the stride length and frequency information is measured by the sensing module after the patient wears the acupoint electrical stimulation lower limb rehabilitation device without applying mechanical force assistance and acupoint electrical stimulation assistance;

[0028] According to the stride and frequency information of the patient, the stride and frequency information of the healthy person with the highest similarity is found from the original data set, and the total force F of the healthy person is used as the total As the total force F recommended for the patient total .

[0029] Furthermore, the neural network model is a feedforward neural network model;

[0030] And / or, the training method of the neural network model includes:

[0031] Step A1: construct an original data set, which includes stride length and frequency information and F total , wherein the stride length and frequency information is measured by the sensor module after a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance. total The force is measured by the force sensor when a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0032] Step A2: Obtain the initial force F of the historical patient initial and the total force F recommended for this patient with this history total , where the F initial The force sensor is used to measure the affected leg of a historical patient wearing the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0033] Step A3: According to formula F total =F initial +F e +F mech Calculate the acupoint electrical stimulation force F required by the patient e and mechanical force F mech ;

[0034] Step A4: Based on the patient's history total 、F initial 、F e and F mech Construct a training set, where F total and F initial is the input data, F e and F mechTo output data, i.e., labels;

[0035] Step A5: Use the training set to train the neural network model.

[0036] Furthermore, the step S103 includes:

[0037] Step S1031: using the sensor module to determine the patient's current gait cycle, the gait cycle includes a stance phase and a swing phase, the stance phase includes a stance period and a pedaling period;

[0038] Step S1032: According to the patient's current gait cycle, the acupoint electrical stimulation lower limb rehabilitation device adopts a corresponding control strategy.

[0039] Furthermore, the step S1032 includes:

[0040] When in the pedaling phase, the driving device is tightened to dorsiflex the foot; when in the swinging phase, the Bowden cable is relaxed to dorsiflex the foot; when in the support phase, the driving device applies a certain force to counteract the dorsiflexion force of the swinging phase, while ensuring that the foot touches the ground for support;

[0041] and / or, when in the stance phase, the yin meridian acupoint electrodes apply strong stimulation to cause dorsiflexion of the foot; when in the swing phase, the yang meridian acupoint electrodes apply strong stimulation to cause dorsiflexion of the foot;

[0042] And / or, when in the stance phase, the yang meridian acupoint electrodes apply weak stimulation to cause dorsiflexion of the foot; when in the swing phase, the yin meridian acupoint electrodes apply weak stimulation to cause dorsiflexion of the foot.

[0043] The present invention has the following beneficial effects:

[0044] The acupoint electrical stimulation lower limb rehabilitation equipment of the present invention is different from the existing lower limb exercise assisting equipment. The existing lower limb exercise assisting equipment uses a purely mechanical method to provide assistance to help the affected limb complete the foot pedaling action, which easily makes the patient dependent on mechanical assistance and gradually loses the active contraction function of the muscles. In the long run, it is not conducive to the patient's active rehabilitation. The present invention, on the premise that the patient provides the main force, mobilizes the patient's own active rehabilitation ability through electrical stimulation, maintains the patient's movement posture through passive mechanical force, combines active, passive and electrical stimulation, avoids the disadvantages of pure external force-assisted exercise, and ensures the best effect of rehabilitation training. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is a schematic diagram of the overall structure of the acupoint electrical stimulation lower limb rehabilitation device of the present invention;

[0046] Figure 2 for Figure 1 A rear view structural diagram of ;

[0047] Figure 3 for Figure 1 Schematic diagram of the usage status;

[0048] Figure 4 for Figure 1 The coordinate system relationship diagram of the angle and angular velocity measured by the sensor module;

[0049] Figure 5 for Figure 1 A schematic diagram of the flow of the method of using the acupoint electrical stimulation lower limb rehabilitation device shown;

[0050] Figure 6 It is a schematic diagram of matching the affected limb movement of the patient in the present invention with the closest healthy person limb movement model;

[0051] Figure 7 It is a schematic diagram of collecting the angle and angular velocity of the user's limb movement and the gait information in the present invention. DETAILED DESCRIPTION

[0052] In order to make the technical problems, technical solutions and advantages to be solved by the present invention more clear, a detailed description will be given below with reference to the accompanying drawings and specific embodiments.

[0053] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by the terms "up", "down", "front", "back", "left", "right", etc. are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation on the present invention.

[0054] On the one hand, the present invention provides a device for lower limb rehabilitation by electrical stimulation of acupoints, which can be used to perform transcutaneous electrical stimulation of the lower limbs to improve dorsum of the foot during exercise, such as Figure 1-3 As shown, it includes a dorsal foot auxiliary exercise device, which includes a leg support frame 1 for fixing on a human calf 7 and a foot support frame 2 hinged at the lower end of the leg support frame 1 for fixing on a human foot 8 and capable of driving the foot 8 to move;

[0055] The instep auxiliary exercise device also includes a driving device 3 for driving the foot support frame 2 to rotate around the hinge between the leg support frame 1 and the foot support frame 2 to drive the foot 8 to move, and the driving device 3 is electrically connected to the control processing terminal 4;

[0056] The instep auxiliary exercise device is provided with a sensor module, which includes a first inertial measurement unit (IMU1) 51 located on the upper part of the leg support frame 1 for measuring the movement state of the calf 7 and a second inertial measurement unit (IMU2) 52 located on the foot support frame 2 for measuring the movement state of the foot 8;

[0057] The leg support frame 1 includes an inner support plate 11 for being placed on the inner side of the calf 7 and an outer support plate 12 for being placed on the outer side of the calf 7. An electrical stimulation electrode is provided on the leg support frame 1. The electrical stimulation electrode includes a Yin meridian acupoint electrode 13 located at the lower part of the inner support plate 11 for stimulating the Yin meridian acupoints and a Yang meridian acupoint electrode 14 located at the upper part of the outer support plate 12 for stimulating the Yang meridian acupoints. The Yin meridian acupoint electrode 13 and the Yang meridian acupoint electrode 14 are both electrically connected to the control processing terminal 4.

[0058] When in use, the patient wears the acupoint electrical stimulation lower limb rehabilitation equipment of the present invention on the affected leg. The sensor module is the main measurement unit for the movement angle and speed, and collects information such as the movement stride, frequency, start and stop acceleration, etc. Specifically, the first inertial measurement unit 51 is mainly used to measure the movement speed of the calf 7 and the angle with the ground, and the second inertial measurement unit 52 is mainly used to measure the angle and angular velocity of the instep with the ground; the control and processing terminal 4 controls the drive device 3 and the electrical stimulation electrodes according to the information collected by the sensor module and the treatment plan determined by the operator, that is, while controlling the drive device 3 to drive the foot support frame 2 to rotate around the hinge of the leg support frame 1 and the foot support frame 2 to drive the foot 8 to move, the yin meridian acupoint electrodes 13 and the yang meridian acupoint electrodes 14 are controlled to give corresponding electrical stimulation respectively according to different movement stages.

[0059] The acupoint electrical stimulation lower limb rehabilitation equipment of the present invention is different from the existing lower limb exercise assisting equipment. The existing lower limb exercise assisting equipment uses a purely mechanical method to provide assistance to help the affected limb complete the foot pedaling action, which easily makes the patient dependent on mechanical assistance and gradually loses the active contraction function of the muscles. In the long run, it is not conducive to the patient's active rehabilitation. The present invention, on the premise that the patient provides the main force, mobilizes the patient's own active rehabilitation ability through electrical stimulation, maintains the patient's movement posture through passive mechanical force, combines active, passive and electrical stimulation, avoids the disadvantages of pure external force-assisted exercise, and ensures the best effect of rehabilitation training.

[0060] The present invention is a related technology of transcutaneous electrical acupoint stimulation (TEAS), which is mainly used in the field of lower limb rehabilitation. TEAS is integrated into the device to assist the patient in active rehabilitation training, so as to improve the walking disorder of hemiplegic patients.

[0061] In order to adapt to patients with different physiological characteristics such as age, gender and body shape, the device of the present invention can be divided into three models of L, M and S according to different heights and weights to ensure the matching fit and the rationality of the corresponding acupoints and sensor positions.

[0062] For the convenience of measurement and calculation, the second inertial measurement unit 52 can be located below the hinge of the leg support frame 1 and the foot support frame 2, and the first inertial measurement unit 51 and the second inertial measurement unit 52 are both located on the outside of the calf parallel to the force line of the lower limb. At the beginning of the design, the first inertial measurement unit 51 and the second inertial measurement unit 52 are designed to be located on the outside of the calf parallel to the force line of the lower limb. Because the main purpose of calculating the movement of the calf and the dorsum of the foot in the forward direction plane (i.e., sagittal position), the Y-axis coordinates of the two sensors can be simply counted as 0, so that the angle change relationship can be more directly reflected on the plane of the X-axis and the Z-axis. The main relationship is as follows: Figure 4 As shown, the coordinates of the first inertial measurement unit 51 can be used as the overall reference coordinates, and its origin is the origin of the entire coordinate system. At the same time, the angle between the two in the patient's neutral position is defined as 0. At this time, the angle change of the second inertial measurement unit 52 relative to the first inertial measurement unit 51 is the angle change value of the extension and flexion of the ankle joint during movement. The angle of the two in the neutral position is 0. When the dorsiflexion is performed, that is, the toes move upward, the angle change and angular velocity are positive values, and when the plantar flexion is performed, that is, the toes move downward, the angle change and angular velocity are negative values. According to the angle and angular velocity changes calculated by the sensor module, various gait models of people can be drawn.

[0063] like Figure 2 As shown, the hinge axis 64 of the leg support frame 1 and the foot support frame 2 is preferably based on the infra-ankle joint surface under the medial malleolus and the protectively supported lateral malleolus as the axis. That is to say, in the present invention, the ankle is the center line of the entire force, but its motion axis (the medial and lateral malleolus fit anatomical fixed axis 63) is different from the fixable axis of the device. The fixation of the connection between the leg support frame 1 and the foot support frame 2 adopts the design concept of anatomical fit. If the medial and lateral malleolus are used as the main fixed core, the lateral malleolus is lower than the medial malleolus, that is, the medial malleolus fixed core 61 is higher than the lateral malleolus fixed core 62, and the fixed axes on both sides are not on the same horizontal axis, which is not conducive to the use of the device. Therefore, the present invention sets the motion axis of the device (that is, the hinge axis 64 of the leg support frame 1 and the foot support frame 2) to be based on the infra-ankle joint surface under the medial malleolus and the protectively supported lateral malleolus as the axis, thereby ensuring that the hinge axis 64 / the fixed axes on both sides are on the same horizontal axis, which is convenient for the control and use of the device, and for patients who already have foot and ankle problems or are recovering from related injuries, it helps to reduce the pressure on the injured area and improve the recovery effect.

[0064] The inner surface of the connection between the entire leg support frame 1 and the foot support frame 2 can be covered with a flexible material, and then fixed to the calf through an outer strap, which is in line with the anatomical structure, ensuring that the entire device is stably fixed. At the same time, its movement axis is consistent with the physiological movement axis of the human body and is close to the fixed core of the equipment. As the force unit of the entire design, it takes into account both stability and mobility, while ensuring the comfort and convenience of the entire device at the ankle.

[0065] Preferably, the Yin meridian acupoint electrode 13 includes a first electrode 131 for attaching to the Sanyinjiao acupoint and a second electrode 132 for attaching to the Zhaohai acupoint, and the Yang meridian acupoint electrode 14 includes a third electrode 141 for attaching to the Zusanli acupoint and a fourth electrode 142 for attaching to the Yanglingquan acupoint. The positions of the electrodes in the figure are only for illustration and need to be consistent with the corresponding acupoint positions when used.

[0066] In this way, the electrical stimulation electrodes are respectively connected to two groups of electrical signals in the leg supporting components on both sides (the inner support plate 11 and the outer support plate 12). The first group is connected to the third electrode 141 at the Zusanli acupoint and the fourth electrode 142 located at the Yanglingquan acupoint. This electrical signal is a yang meridian acupoint signal, which is mainly responsible for the contraction stimulation of the tibialis anterior, peroneus long and brevis muscles; the second group is the first electrode 131 connected to the Sanyinjiao acupoint and the second electrode 132 located at the Zhaohai acupoint. This electrical signal is a yin meridian acupoint signal, which is mainly responsible for the muscle contraction of the tibialis posterior muscle. In this way, electrical stimulation of the corresponding acupoints in the corresponding movement stages (such as lifting the legs and lowering the legs) can activate nerves and muscles, promote blood circulation, relieve pain and accelerate tissue repair, thereby maintaining or gradually restoring the functional state of the muscles.

[0067] The electrical stimulation electrode can be pressed onto the skin surface directly or after applying a coupling agent, thereby reducing resistance, improving current transfer efficiency, and ensuring more uniform and effective stimulation. The electrical stimulation electrode can be circular and have a diameter of 3 cm, that is, the contact area between the electrical stimulation electrode and the skin is less than 32 cm. 2 , reducing discomfort or possible skin damage caused by the current being concentrated at a certain point. The adhesion of the electrical stimulation electrode should be greater than or equal to 105% of the gravity of the corresponding electrode connection line. Sufficient adhesion can ensure that the electrical stimulation electrode fits firmly on the skin surface and will not fall off easily during rehabilitation training even if the patient is active.

[0068] The inner support plate 11 and the outer support plate 12 may be provided with a slide groove (not shown) for accommodating the electrical stimulation electrodes. The slide groove can flexibly adjust the position of each electrical stimulation electrode to ensure that the electrical stimulation electrode is at a predetermined position (i.e., the corresponding acupuncture point), thereby improving the adaptability of the present invention to different patients.

[0069] The front of the upper part of the inner support plate 11 and the outer support plate 12 can be integrally provided with a front arc-shaped connecting portion 15, which can not only better fix the leg support frame 1 on the calf, but also provide a certain degree of protection. The upper rear of the inner support plate 11 and the outer support plate 12, and the lower front of the inner support plate 11 and the outer support plate 12 can be provided with a binding fabric 16, which can tightly wrap the calf and the surrounding area to ensure that the inner support plate 11 and the outer support plate 12 are firmly fixed in place. At the same time, the binding fabric 16 allows the patient to adjust the tightness according to his or her needs to achieve the best comfort and support.

[0070] Continue as Figure 1 As shown, the foot support frame 2 may include a U-shaped connecting member 21 extending backward and downward from the hinge to wrap around the heel, a pair of wing plates 22 extending forward and downward from the hinge to be attached to the instep, and an instep fixing member 23 located at the front end of the pair of wing plates 22.

[0071] The U-shaped connector 21 wrapping around the heel can provide sufficient support and stability, and the wing plate 22 and the instep fixing piece 23 can assist in lifting the forefoot, especially during rehabilitation training, which helps to maintain a natural gait pattern, reduce the discomfort and risks caused by abnormal gait, and thus improve the effect of rehabilitation training.

[0072] The U-shaped connector 21 and the wing plate 22 can be integrally connected via a connecting component 24, and the foot support frame 2 is hingedly connected to the leg support frame 1 via the connecting component 24; the U-shaped connector 21 (wrapping the heel) and the wing plate 22 (attached to the instep) are connected as a whole via the connecting component 24 to form a more solid overall structure, which can provide better support and stability, reduce relative movement between the parts, and thus improve the rehabilitation training effect.

[0073] The instep fixing member 23 can adopt various structural forms that can be easily thought of by those skilled in the art, which are specifically described as follows:

[0074] Structural form 1

[0075] The instep fixing member 23 may include an upper limit plate 231 and a lower limit plate 232 extending horizontally, and a vertical connection plate 233 connecting the upper limit plate 231 and the lower limit plate 232. When in use, the patient's foot is worn between the upper limit plate 231 and the lower limit plate 232, the upper limit plate 231 can assist the foot to fall, the lower limit plate 232 can assist the foot to lift, and the vertical connection plate 233 connects the upper limit plate 231 and the lower limit plate 232 as a whole. The design of the entire fixing member helps to maintain a normal gait pattern and improve the effect of rehabilitation training.

[0076] Structural form 2

[0077] The instep fixing piece 23 can be a strap that is wrapped around the sole of the foot through a flexible fabric. The strap can not only assist the foot movement, but also the tightness of the strap can be easily adjusted according to one's needs.

[0078] Furthermore, the wing plate 22 may include a base portion 221 at the rear and an expansion portion 222 vertically hinged on the base portion 221 and extending forward and laterally expandable, and the instep fixing member 2 is located at the front end of the expansion portion 222. In this way, since two longitudinal rotation axis structures are added between the base portion 221 and the expansion portion 222, it is convenient for patients to wear the shoe, and a wide range of lateral ankle movement space can be ensured.

[0079] The main body of the foot support frame 2 can be made of fiber reinforced composite materials (FRP), and fiber reinforced composite materials include but are not limited to glass fiber, carbon fiber, aramid fiber and composite materials. Because their Poisson's ratio is relatively low, they can have a certain lateral deformation under force and a smaller longitudinal deformation. At the same time, the material is designed to be wider in the longitudinal direction and narrower in the transverse direction. On the one hand, this can facilitate the wearing of shoes, and on the other hand, it ensures the lateral joint micro-activity space of the ankle joint. The flexible design is more conducive to the patient's self-exertion and helps rehabilitation.

[0080] In order to facilitate the application of passive force, the driving device 3 can adopt various methods that can be easily thought of by those skilled in the art, such as motor drive, etc. For the convenience of implementation, the driving device 3 preferably includes a support rod 31 and a transmission device 32 electrically connected to the control processing terminal 4 for driving the support rod 31 to move up and down, wherein:

[0081] The transmission device 32 is located at the upper end of the support rod 31, and the lower end of the support rod 31 is drivingly connected to the U-shaped connecting piece 21;

[0082] A rear arc-shaped connecting portion 17 is integrally provided at the lower rear of the inner supporting plate 11 and the outer supporting plate 12 , and the transmission device 32 is fixed on the rear arc-shaped connecting portion 17 .

[0083] The transmission device 32 is fixed on the rear arc-shaped connecting portion 17 to firmly fix the transmission device 32, so that the transmission device 32 can stably drive the support rod 31 to move up and down to drive the U-shaped connecting piece 21 connected to the lower end of the support rod 31 to move, thereby realizing the supply of passive force.

[0084] The transmission device 32 can be a Bowden cable transmission device. At this time, the traditional device 32 can use the support rod 31 to bidirectionally regulate the support rod 31 through the Bowden cable driving movement with the connecting part 24 as the axis, so as to drive the patient wearing this device to passively extend and plantar flex. In specific implementation, the transmission device 32 can be connected to the control processing terminal 4 through a mechanical cable with a catheter outer layer, and the accompanying electrical cable is also responsible for power supply and electrical stimulation signal connection.

[0085] The driving device 3 may be provided with a force sensor 32 for detecting the driving force of the foot support frame 2. In specific implementation, a force sensor 32 may be provided on the support rod 31. The force sensor 32 is used to record the force of the support rod 31 when the ankle joint moves, and plays a role in triggering movement, measuring autonomous movement force, and monitoring excessive force.

[0086] There can be two dorsi pedis assisted exercise devices that share a control processing terminal 4. In this case, the dorsi pedis assisted exercise device is designed to be worn on both legs. After obtaining relevant walking data by measuring the patient's healthy leg and affected leg, a treatment plan is determined and applied to the dorsi pedis assisted exercise device of the affected leg; the dorsi pedis assisted exercise device of the healthy leg is mainly used to realize the collection and measurement of relevant walking data.

[0087] The control processing terminal 4 may include a processor (not shown), which is connected to an adjustment button 41, a display 42, and a rope-driven control system (not shown) for controlling the transmission device 32. The processor is responsible for analyzing the device's signals and the overall control strategy; the rope-driven control system controls the support rod 31 through the rope after receiving the processor's command; the adjustment button 41 may specifically be composed of a manual stimulation power knob, a cadence knob, a passive motion force knob, etc., for manual adjustment outside the automatic control strategy; the display 42 may display the status of related adjustable parameters, the current gait curve and the target gait curve, and guide and monitor the rehabilitation exercise effect.

[0088] On the other hand, the present invention provides a method for performing rehabilitation training using the above-mentioned acupoint electrical stimulation lower limb rehabilitation device, such as Figure 5 As shown, including:

[0089] Step S101: Obtain the patient's initial force F initial and the total force F recommended for the patient total , wherein the F initial After the patient wears the acupoint electrical stimulation lower limb rehabilitation device on the affected leg, the force sensor measures the F total The force is measured by the force sensor when a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0090] Step S102: The F initial and F total Input the pre-trained neural network model to obtain the acupoint electrical stimulation force F required by the patient e and mechanical force F mech , wherein the F initial 、F total 、F e and F mech Satisfy formula Ftotal =F initial +F e +F mech ;

[0091] In this step, the neural network model can be flexibly selected according to the needs. The present invention preferably uses a forward feedback neural network model. In specific implementation, the model architecture can be constructed using Python, and the basic logic is as follows:

[0092] import tensorflow as tf

[0093] from tensorflow import keras

[0094] from tensorflow.keras import layers

[0095] input_dim=0# Assume there are 2 input features

[0096] output_dim=2# Output F e and F mech

[0097] model = keras.Sequential(

[0098] layers.Input(shape=(input_dim,)),

[0099] layers.Dense(64, activation='relu'),

[0100] layers.Dense(64, activation='relu'),

[0101] layers.Dense(output_dim, activation='linear') #Output F e and F mech ))

[0103] model.compile(optimizer='adam', loss='mse')

[0104] Step S103: According to the F e and F mech The acupoint electrical stimulation lower limb rehabilitation equipment is controlled to perform rehabilitation training on the patient.

[0105] In this way, through the above steps S101-S103, rehabilitation training using acupoint electrical stimulation lower limb rehabilitation equipment can be conveniently implemented.

[0106] As an optional embodiment, step S101 may include:

[0107] Step B1: Acquire the patient's stride length and frequency information, wherein the stride length and frequency information is measured by the sensing module after the patient (which may be the affected leg, preferably the healthy leg) wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0108] In this step, when the patient visits the doctor, he or she may wear the device of the present invention on one or both legs to collect data and collect the patient's stride length and frequency information. The calculation method of the stride length and frequency is common knowledge in the art and will not be repeated here.

[0109] Step B2: Based on the stride and frequency information of the patient, find the stride and frequency information of the healthy person with the highest similarity from the original data set, and use the total force F of the healthy person as the total As the total force F recommended for the patient total .

[0110] In the specific implementation, the stride length and frequency information of the patient and the healthy person are analyzed and compared, and the closest fitting object in the original data set is matched as the corresponding fitting object, that is, the total force F of the healthy person (the closest fitting object) is used. total As the total force F recommended for the patient total ,like Figure 6 As shown, the solid line corresponds to healthy people and the dotted line corresponds to patients.

[0111] In this way, through the above steps B1-B2, the total force F can be recommended to the patient more accurately. total .

[0112] As another optional embodiment, the training method of the neural network model may include:

[0113] Step A1: construct an original data set, which includes stride length and frequency information and F total , wherein the stride length and frequency information is measured by the sensor module after a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance. total The force is measured by the force sensor when a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0114] In this step, the stride and frequency information of a large number of healthy people are collected through the sensing module (the first inertial measurement unit and the second inertial measurement unit), and the F corresponding to the stride and frequency information is collected through the force sensor. total , using stride length and frequency information and F total Create the original dataset.

[0115] Step A2: Obtain the initial force F of the historical patient initial and the total force F recommended for this patient with this history total , where the F initial The force sensor is used to measure the patient's affected side wearing the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance;

[0116] In this step, the total force F recommended for this historical patient total The selection method is the same as the aforementioned steps B1-B2 and will not be repeated here.

[0117] Step A3: According to formula F total =F initial +F e +F mech Calculate the acupoint electrical stimulation force F required by the patient e and mechanical force F mech ;

[0118] In this step, if Figure 6 As shown, Figure 6 The difference between the solid line and the dotted line in the last coordinate diagram is the difference in force at different times, where the solid line represents the total force of a healthy person and the dotted line represents the initial force F of the patient. initial , the difference between it and the normal leg is caused by the mechanical force F mech +Electrical stimulation F e We simulate normal gait by maintaining the complementary coordination between passive force, active force and electrical stimulation force, namely F total =F initial +F e +F mech , to ensure that the output gait is close to the normal gait level.

[0119] Take the process of pedaling in the shaded part as an example: F total It can be obtained by measuring healthy people with force sensors, F initial It can be measured without any assistance from the patient. In the early stage of device use when data is insufficient (i.e., during the model training period), F e The initial load value can be obtained through the electrical stimulation universal quantity, so as to calculate the auxiliary F required for the rope drive system. mech , and finally get F e and Fmech .

[0120] Patients follow this F e and F mech During rehabilitation training, doctors can manually adjust F by monitoring the screen and the patient's feedback. e and F mech , until the patient's gait reaches the best, and record the F at this time (i.e. after adjustment). e and F mech As the final calculated F e and F mech .

[0121] Step A4: Based on the patient's history total 、F initial 、F e and F mech Construct a training set, where F total and F initial is the input data, F e and F mech To output data, i.e., labels;

[0122] Step A5: Use the training set to train the neural network model.

[0123] In this way, through the above steps A1-A5, the training of the neural network model can be completed. After a large amount of data is accumulated over a long period of time, the neural network model can derive a more reasonable F e and F mech value, thereby improving the effect of rehabilitation training.

[0124] As another optional embodiment, the step S103 may include:

[0125] Step S1031: using the sensor module to determine the patient's current gait cycle, the gait cycle includes a stance phase and a swing phase, the stance phase includes a stance period and a pedaling period;

[0126] In the present invention, the gait cycle is classified into a support phase and a swing phase according to whether the foot contacts the ground. The support phase is further divided into a support phase in the first half that generates less force and plays a role in stabilizing the body shape - the support phase, and a support phase that generates force and drives the body forward - the foot push phase.

[0127] In this step, the sensor module can be used to obtain information such as angle and angular velocity of a single leg or double leg gait, and the current gait condition can be determined based on this information. Figure 7 As shown, when the dark-colored leg on the healthy side is in the swing phase, the light-colored leg on the affected side is in the support phase, and the relationship, angle and angular velocity state of the dark-colored leg and the light-colored leg can be recorded by the sensor module.

[0128] Step S1032: According to the patient's current gait cycle, the acupoint electrical stimulation lower limb rehabilitation device adopts a corresponding control strategy.

[0129] In this step, different control strategies are used according to the patient's current gait cycle to make the released electricity reach the bilateral Zusanli, Yanglingquan, Sanyinjiao, Zhaohai and other acupoints under different gaits, guide the muscles to contract in an orderly manner, and at the same time cooperate with the motor unit of the flexible ankle joint to give dorsiflexion force to the ankle joint, so as to make the ankle joint move and walk.

[0130] Preferably, the step S1032 includes:

[0131] When in the pedaling phase, the driving device is tightened to dorsiflex the foot; when in the swinging phase, the Bowden cable is relaxed to dorsiflex the foot; when in the support phase, the driving device applies a certain force to counteract the dorsiflexion force of the swinging phase, while ensuring that the foot touches the ground for support;

[0132] and / or, when in the stance phase, the yin meridian acupoint electrodes apply strong stimulation to cause dorsiflexion of the foot; when in the swing phase, the yang meridian acupoint electrodes apply strong stimulation to cause dorsiflexion of the foot;

[0133] And / or, when in the stance phase, the yang meridian acupoint electrodes apply weak stimulation to cause dorsiflexion of the foot; when in the swing phase, the yin meridian acupoint electrodes apply weak stimulation to cause dorsiflexion of the foot.

[0134] That is to say, the control strategies of different phase cycles can be shown in Table 1:

[0135] Table 1

[0136]

[0137] In this embodiment, in order to obtain the best rehabilitation training effect, the electrical stimulation mode adopts a time-alternating stimulation mode, namely: during the swing phase (from toe off the ground to heel touching the ground), strong stimulation of the Yang meridian (Zusanli + Yanglingquan) - dorsiflexion + weak stimulation of the Yin meridian (Zhaohai + Sanyinjiao); during the support phase (from heel touching the ground to toe off the ground), strong stimulation of the Yin meridian (Zhaohai + Sanyinjiao) - plantar flexion + weak stimulation of the Yang meridian (Zusanli + Yanglingquan).

[0138] Among them, strong stimulation is defined as: the maximum current intensity that the patient can tolerate (without causing pain) and / or obvious muscle contraction, and is less than the maximum limiting current; weak stimulation is defined as: the current intensity is 5mA.

[0139] The electrical stimulation parameters can be set as follows:

[0140] Output channels: 4 channels, 2 per limb

[0141] Current intensity: 0-50mA

[0142] Pulse waveform: Bidirectional symmetrical square wave

[0143] Pulse width: 200mμ

[0144] Stimulation frequency: 100Hz

[0145] Output current limit: 100mA (can be adjusted flexibly according to needs).

[0146] In general, the present invention collects and launches instructions through sensor recognition of ankle joint movement patterns and movement intentions, and uses acupoint electrical stimulation and mechanical passive methods to drive muscle contraction to flex and extend the ankle for walking, thereby achieving central remodeling and limb function reconstruction.

[0147] Most of the existing lower limb exercise assistive devices use purely mechanical methods to provide assistance to help the affected limb complete the pedaling action. There are two core problems in this design that need to be improved. 1. It emphasizes the external force-assisted exercise function and ignores the mobilization of the patient's own ability to actively recover. It can maintain the patient's exercise posture, but it is also easy for the patient to become dependent on mechanical assistance and gradually lose the active contraction function of the muscles. In the long run, it is not conducive to the patient's active rehabilitation. 2. It can mainly generate adjustable force during the pedaling phase to improve the state of weak pedaling, but in a real healthy gait, the dorsiflexion of the foot in the swing phase is equally important for the patient's normal gait. If this part is purely achieved by relying on the fixed tension of the mechanical spring, the autonomy and flexibility of the gait cannot be achieved.

[0148] The present invention perfectly solves the above problems by using the method of neural electrical stimulation and the method of mechanical assistance in coordination with each other. First, based on the rehabilitation principle, the patient's own muscle strength is recorded by a force sensor, and the strong and weak signals of electrical stimulation are added to keep the muscles of the affected limb in the rehabilitation state in alternating strong and weak muscle tension, and try to complete the exercise rehabilitation movements. For the situation where the force required in the pedaling state is large and cannot be completed by the patient's own strength plus electrical stimulation, mechanical force is used to provide assistance. Electrical stimulation and mechanical assistance complement each other, while also avoiding the drawbacks of pure external force-assisted exercise, ensuring the best effect of rehabilitation training.

[0149] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. An acupoint electrical stimulation lower limb rehabilitation device, characterized in that: It includes a dorsal instep auxiliary exercise device, which includes a leg support frame for fixing on the calf of a human body and a foot support frame hinged at the lower end of the leg support frame for fixing on the foot of a human body and capable of driving the foot to move; The instep auxiliary exercise device also includes a driving device for driving the foot support frame to rotate around the hinge of the leg support frame and the foot support frame to drive the foot to move, and the driving device is electrically connected to the control processing terminal; The instep auxiliary exercise device is provided with a sensor module, and the sensor module includes a first inertial measurement unit located on the upper part of the leg support frame for measuring the movement state of the calf and a second inertial measurement unit located on the foot support frame for measuring the movement state of the foot; The leg support frame includes an inner support plate for being placed on the inner side of the calf and an outer support plate for being placed on the outer side of the calf. The leg support frame is provided with electrical stimulation electrodes, and the electrical stimulation electrodes include Yin meridian acupoint electrodes located at the lower part of the inner support plate for stimulating Yin meridian acupoints and Yang meridian acupoint electrodes located at the upper part of the outer support plate for stimulating Yang meridian acupoints. The Yin meridian acupoint electrodes and the Yang meridian acupoint electrodes are both electrically connected to the control processing terminal.

2. The acupoint electrical stimulation lower limb rehabilitation device according to claim 1, characterized in that: The second inertial measurement unit is located below the hinge of the leg support frame and the foot support frame, and the first inertial measurement unit and the second inertial measurement unit are both located on the outside of the calf parallel to the force line direction of the lower limb; And / or, the hinge axis of the leg support frame and the foot support frame is based on the inframalar joint surface under the medial malleolus and the protectively supported lateral malleolus as the axis.

3. The acupoint electrical stimulation lower limb rehabilitation device according to claim 1, characterized in that: The yin meridian acupoint electrodes include a first electrode for attaching to the Sanyinjiao acupoint and a second electrode for attaching to the Zhaohai acupoint, and the yang meridian acupoint electrodes include a third electrode for attaching to the Zusanli acupoint and a fourth electrode for attaching to the Yanglingquan acupoint; And / or, the upper front of the inner support plate and the outer support plate are integrally provided with a front arc-shaped connecting portion; and / or, binding fabrics are provided at the upper rear of the inner and outer support plates; And / or, binding fabrics are provided at the front of the lower parts of the inner supporting plates and the outer supporting plates.

4. The acupoint electrical stimulation lower limb rehabilitation device according to any one of claims 1 to 3, characterized in that: The foot support frame includes a U-shaped connector extending backward and downward from the hinge to wrap around the heel, a pair of wing plates extending forward and downward from the hinge to attach to the instep, and an instep fixing member located at the front end of the pair of wing plates.

5. The acupoint electrical stimulation lower limb rehabilitation device according to claim 4, characterized in that: The driving device includes a support rod and a transmission device electrically connected to the control processing terminal for driving the support rod to move up and down, the transmission device is located at the upper end of the support rod, and the lower end of the support rod is drivingly connected to the U-shaped connecting piece; a rear arc-shaped connecting part is integrally provided at the lower rear of the inner support plate and the outer support plate, and the transmission device is fixed on the rear arc-shaped connecting part; and / or, the driving device is provided with a force sensor for detecting the driving force of the foot support frame; And / or, the number of the instep auxiliary exercise devices is two and they share one control processing terminal; And / or, the transmission device is a Bowden cable transmission device, and the control processing terminal includes a processor, and the processor is connected to an adjustment button, a display, and a rope drive control system for controlling the transmission device.

6. A method for performing rehabilitation training using the acupoint electrical stimulation lower limb rehabilitation device according to claim 5, characterized in that: include: Step S101: Obtain the patient's initial force F initial and the total force F recommended for the patient total , wherein the F initial After the patient wears the acupoint electrical stimulation lower limb rehabilitation device on the affected leg, the force sensor measures the F total The force is measured by the force sensor when a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance; Step S102: The F initial and F total Input the pre-trained neural network model to obtain the acupoint electrical stimulation force F required by the patient e and mechanical force F mech , wherein the F initial 、F total 、F e and F mech Satisfy formula F total =F initial +F e +F mech ; Step S103: According to the F e and F mech The acupoint electrical stimulation lower limb rehabilitation equipment is controlled to perform rehabilitation training on the patient.

7. The method according to claim 6, characterized in that The step S101 includes: Acquiring the patient's stride length and frequency information, wherein the stride length and frequency information is measured by the sensing module after the patient wears the acupoint electrical stimulation lower limb rehabilitation device without applying mechanical force assistance and acupoint electrical stimulation assistance; According to the stride and frequency information of the patient, the stride and frequency information of the healthy person with the highest similarity is found from the original data set, and the total force F of the healthy person is used as the total As the total force F recommended for the patient total .

8. The method according to claim 6, characterized in that The neural network model is a feedforward neural network model; And / or, the training method of the neural network model includes: Step A1: construct an original data set, which includes stride length and frequency information and F total , wherein the stride length and frequency information is measured by the sensor module after a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance. total The force is measured by the force sensor when a healthy person wears the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance; Step A2: Obtain the initial force F of the historical patient initial and the total force F recommended for this patient with this history total , where the F initial The force sensor is used to measure the affected leg of a historical patient wearing the acupoint electrical stimulation lower limb rehabilitation device without mechanical force assistance and acupoint electrical stimulation assistance; Step A3: According to formula F total =F initial +F e +F mech Calculate the acupoint electrical stimulation force F required by the patient e and mechanical force F mech ; Step A4: Based on the patient's history total 、F initial 、F e and F mech Construct a training set, where F total and F initial is the input data, F e and F mech To output data, i.e., labels; Step A5: Use the training set to train the neural network model.

9. The method according to claim 6, characterized in that The step S103 includes: Step S1031: using the sensor module to determine the patient's current gait cycle, the gait cycle includes a stance phase and a swing phase, the stance phase includes a stance period and a pedaling period; Step S1032: According to the patient's current gait cycle, the acupoint electrical stimulation lower limb rehabilitation device adopts a corresponding control strategy.

10. The method according to claim 6, characterized in that The step S1032 includes: When in the pedaling phase, the driving device is tightened to dorsiflex the foot; when in the swinging phase, the Bowden cable is relaxed to dorsiflex the foot; when in the support phase, the driving device applies a certain force to counteract the dorsiflexion force of the swinging phase, while ensuring that the foot touches the ground for support; and / or, when in the stance phase, the yin meridian acupoint electrodes apply strong stimulation to cause dorsiflexion of the foot; when in the swing phase, the yang meridian acupoint electrodes apply strong stimulation to cause dorsiflexion of the foot; And / or, when in the stance phase, the yang meridian acupoint electrodes apply weak stimulation to cause dorsiflexion of the foot; when in the swing phase, the yin meridian acupoint electrodes apply weak stimulation to cause dorsiflexion of the foot.

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