Method for rehabilitation of patients who have suffered stroke
Patent Information
- Application Number
- RU2026108614
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2026-03-26
- Publication Date
- 2026-10-06
- Estimated Expiration
- 2046-03-26
Abstract
Description
[0001] The invention relates to medicine, namely to neurology, medical rehabilitation, physiotherapy and can be used for the rehabilitation of patients who have suffered an ischemic stroke with impaired function of the upper limb. Stroke is a leading cause of death and disability worldwide. Disability rates after stroke rank first, ranging from 75% to 85%, with only 8-15% of patients returning to work (Bogolepova A.N., Levin O.S. Cognitive rehabilitation of patients with focal brain damage. Korsakov Journal of Neurology and Psychiatry. 2020; 120(4): 115-122). Currently, ischemic stroke remains one of the most important and pressing medical and social problems, leading to serious economic and social consequences. According to the 2016 Global Burden of Disease report, published in 2019 (GBD 2016 Occupational Risk Factors Collaborators. "Global and regional burden of disease and injury in 2016 arising from occupational exposures: a systematic analysis for the Global Burden of Disease Study 2016." Occupational and environmental medicine vol. 77.3 (2020): 133-141), every fourth person will experience a stroke during their lifetime.The attention of medical specialists in the field of neurology and neurorehabilitation is drawn to the study and correction of the consequences of strokes, which most often represent disorders of motor, speech and cognitive functions (Boldrini, P. The Individual Rehabilitation Project as the core of person-centered rehabilitation: the Physical and Rehabilitation Medicine Section and Board of the European Union of Medical Specialists Framework for Rehabilitation in Europe / / European Journal of Physical and Rehabilitation Medicine. - 2022. - Vol. 58, No. 4. - P. 503-510).
[0003] An important goal of rehabilitation after stroke is to improve the quality of life by increasing functional independence and participation in activities (Abramovich S.G., Knyazyuk O.O., Kazakov N.P. Predicting the results of rehabilitation treatment in patients with ischemic stroke at the second stage of rehabilitation / / Bulletin of Physiotherapy and Balneology. 2023. No. 1). The presence of neurological deficit in the form of dysfunction of the upper limb is one of the main indicators of decreased quality of life after stroke. (Engineer ND, Kimberley TJ, Prudente CN, Dawson J, Tarver WB and Hays SA (2019) Targeted Vagus Nerve Stimulation for Rehabilitation After Stroke. Front. Neurosci. 13: 280.doi: 10.3389 / fhins.2019.00280).
[0004] Due to the insufficient effectiveness of existing rehabilitation methods, the development of new rehabilitation methods aimed at restoring patients who have suffered a stroke is a pressing problem in modern medicine (Ivanova G.E., Bodrova R.A., Builova T.V. [et al.] / Algorithm for formulating a rehabilitation diagnosis using the International Classification of Functioning for a patient who has suffered a stroke: a clinical case / / Physical and rehabilitation medicine, medical rehabilitation. - 2022. - Vol. 4, No. 1. - P. 37-54)
[0005] A search of scientific, medical and patent literature revealed various methods of rehabilitation for patients who have suffered a stroke.
[0006] For example, Russian Patent No. 2770595 "Rehabilitation Method" (published April 18, 2022) describes a method for rehabilitating stroke patients. The method involves the patient performing exercises from a set of computer game-based exercises using a rehabilitation device. The rehabilitation device—rehabilitation gloves—is connected to a computer, ensuring the patient's hand is in contact with the device's sensors. During the exercises, the position and orientation of the patient's hand is displayed on the computer monitor. Each exercise from the computer game is performed with the first hand, and then repeated with the second hand.
[0007] The disadvantage of this method is the need for visual control of gestures displayed on the monitor screen, which is a limitation for people with visual impairments, and also, according to the authors of the patent, the impossibility of carrying out rehabilitation using this method in cases of severe paresis.
[0008] Patent of the Russian Federation No. 2642950 (published on January 29, 2018) protects the "Method for the rehabilitation of patients with post-stroke disorders in the early recovery period". A patient with post-stroke disorders undergoes multichannel electrical stimulation with bipolar pulsed currents with a frequency of 20 to 120 Hz, a burst and a pause of 2 seconds, until a weak muscle contraction is observed during the first 2-3 procedures. In this case, electrodes are applied to the upper limbs on the middle third of the arm on the outer side at the motor point of the radial nerve, on the middle third of the outer surface of the forearm, on the inner surface of the middle third of the arm in the projection of the ulnar and median nerves, on the inner surface of the forearm; on the lower limbs in the projection of the peroneal nerve and the muscles innervated by it and in the projection of the tibial nerve and the calf muscles innervated by it. The rehabilitation course consists of 8-10 procedures.
[0009] The disadvantage of this method is the duration of rehabilitation, which, according to the authors, is 8-10 procedures.
[0010] The closest technical solution taken as a prototype is described in the work of Wu, D., Ma, J., Zhang, L., Wang, S., Tan, B., & Jia, G. (2020). Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study / / Neural plasticity, 2020. This method is a method for the rehabilitation of patients who have suffered an ischemic stroke with upper limb dysfunction. The method includes examining the patient, exposing the auricular branch of the left vagus nerve to a physical factor, followed by rehabilitation training once a day during the rehabilitation course. The patient's auricular branch of the left vagus nerve is stimulated with an electric current. The stimulation intensity is variable, selected individually depending on the patient's tolerance. Stimulation is carried out once a day for 15 days for 30 minutes.Rehabilitation training includes posture control, proprioception exercises, neuromuscular facilitation, and gait training. Rehabilitation training is conducted after the stimulation is complete.
[0011] The disadvantage of the prototype is the duration of rehabilitation, which, according to the authors of the prototype, is 15 days.
[0012] The objective of the proposed invention is to develop an effective method for the rehabilitation of patients who have suffered an ischemic stroke with impaired function of the upper limb.
[0013] The technical result that is achieved by implementing the claimed method is a reduction in the rehabilitation period for patients who have suffered an ischemic stroke with impaired upper limb function.
[0014] The technical result is achieved by examining the patient, influencing the auricular branch of the left vagus nerve with a physical factor, followed by rehabilitation training once a day during the rehabilitation course. During 5 days of rehabilitation, the auricular branch of the left vagus nerve is exposed to mono- and bipolar rectangular current pulses in the "pulse-pause" modulation mode using rectangular signals from the Mustang-PHYSIO-MELT-1K electrotherapeutic device for exposure to low-frequency pulsed currents, manufactured by Technika LLC (Russia), operating in the "Transcutaneous electrical nerve stimulation (TENS)" mode, followed by rehabilitation training. The first two days, the exposure is performed with rectangular bipolar current pulses with a pulse repetition rate of 26 Hz, a current amplitude of 8.0 mA, a pulse duration of 0.5 ms, a modulating signal duration in the "pulse-pause" mode of 1.0 s and a pause duration between pulses of 0.5 s.The following three days, the exposure is performed with rectangular monopolar current pulses with a pulse repetition frequency of 24 Hz, a current amplitude of 4.0 mA, a pulse duration of 0.3 ms, a modulating signal duration in the "pulse-pause" mode of 2.0 s and a pause duration between pulse pulses of 0.5 s. The duration of each procedure in the first two days is 10 minutes, in the next three days - 20 minutes. After each procedure, rehabilitation training is performed, which includes exercises to train the movements of the paretic limb in accordance with clinical guidelines (Clinical guidelines. Ischemic stroke and transient ischemic attack. 2024. - Text: electronic / / Rubricator of clinical recommendations: website. - URL: https: / / cr.minzdrav.gov.ru / view-cr / 814_1). The rehabilitation course is 5 days.
[0015] Detailed description of the method.
[0016] Before the rehabilitation course, the patient undergoes an ECG, heart rate, and blood pressure assessment to rule out hemodynamic disturbances. During the procedure, the patient is positioned on a couch, either supine or sitting. The auricular branch of the left vagus nerve is stimulated with a physical factor, followed by rehabilitation training once a day for 5 days. This physical stimulation consists of mono- and bipolar rectangular current pulses in burst-pause modulation mode. The rectangular signals are generated by a Mustang-PHYSIO-MELT-1K electrotherapeutic device for low-frequency pulsed currents (manufactured by Technika Research and Production Center, Russia), operating in the "Transcutaneous Electrical Neurostimulation (TENS)" mode, followed by rehabilitation training according to the protocol.The first two days of exposure are performed with rectangular bipolar current pulses with a pulse repetition rate of 26 Hz, a current amplitude of 8.0 mA, a pulse duration of 0.5 ms, a modulating signal duration in the "pulse-pause" mode of 1.0 s, and a pause duration between pulses of 0.5 s. The next three days of exposure are performed with rectangular monopolar current pulses with a pulse repetition rate of 24 Hz, a current amplitude of 4.0 mA, a pulse duration of 0.3 ms, a modulating signal duration in the "pulse-pause" mode of 2.0 s, and a pause duration between pulses of 0.5 s. The duration of each procedure in the first two days is 10 minutes, in the following three days - 20 minutes. After each procedure, rehabilitation training is performed, which includes exercises to train the movements of the paretic limb in accordance with clinical recommendations. The rehabilitation course is 5 days.
[0017] The practical feasibility of the claimed method is illustrated by examples from clinical practice.
[0018] Example 1: Patient A, 55, was admitted for rehabilitation to the neurology department of the Regional Clinical Hospital No. 2 with complaints of weakness and limited movement in his right extremities. Two months earlier, Patient A suffered an ischemic stroke in the left middle cerebral artery with moderate right-sided hemiparesis.
[0019] Nervical status: moderate right-sided hemiparesis. Range of active motion is limited in the left extremities. Muscle strength is decreased proximally in the right arm to 4.0 points, distally to 3 points. Muscle tone is increased in the right extremities according to the pyramidal type, up to 1 point on the Ashworth scale. Tendon reflexes in the upper and lower extremities are D>S, (+) Babinski sign on the right. Asthenic, emotionally labile. Controls pelvic functions.
[0020] Patient A. underwent a rehabilitation course according to the claimed method, consisting of a patient examination, physical stimulation of the auricular branch of the left vagus nerve, followed by rehabilitation training once a day for the duration of the rehabilitation course. Over the course of 5 days of rehabilitation, the auricular branch of the left vagus nerve was stimulated with mono- and bipolar rectangular current pulses in the "pulse-pause" modulation mode using rectangular signals from a Mustang-PHYSIO-MELT-1K electrotherapeutic device for low-frequency pulsed currents manufactured by Technika LLC (Russia), operating in the "Transcutaneous Electrical Neurostimulation (TENS)" mode, followed by rehabilitation training.The first two days of exposure were performed with rectangular bipolar current pulses with a pulse repetition rate of 26 Hz, a current amplitude of 8.0 mA, a pulse duration of 0.5 ms, a modulating signal duration in the "pulse-pause" mode of 1.0 s, and a pause duration between pulses of 0.5 s. The following three days, exposure was performed with rectangular monopolar current pulses with a pulse repetition rate of 24 Hz, a current amplitude of 4.0 mA, a pulse duration of 0.3 ms, a modulating signal duration in the "pulse-pause" mode of 2.0 s, and a pause duration between pulses of 0.5 s. The duration of each procedure in the first two days was 10 minutes, in the following three days - 20 minutes. After each procedure, rehabilitation training was performed, which included exercises to train the movements of the paretic limb in accordance with clinical recommendations.
[0021] Following the rehabilitation course, the patient's overall well-being improved; he became more active and mobile; the range of active movements in the paretic limbs expanded, and muscle strength in the upper limb increased to 4 points; and the hand's object-manipulation function indicators improved. Fine hand function assessment: ARAT scale: 42 points upon admission, 53 points upon discharge; Fugl-Meyer (FMA-UE) scale: 38 points upon admission, 46 points upon discharge. Hemodynamic parameters remained stable throughout the rehabilitation course.
[0022] Example 2: Patient N., 54, was referred for rehabilitation to the neurology department of the Regional Clinical Hospital No. 2 with complaints of weakness and limited active movement in her left extremities, as well as gait and ambulation difficulties. Three months ago, Patient N. suffered an ischemic stroke in the right middle cerebral artery with moderate left-sided hemiparesis.
[0023] Nervical status: Range of active movements is limited in the left limbs, right-sided hemiparesis. Range of active movements is limited in the left limbs. Muscle strength is decreased in the right arm proximally to 3.5 points, distally to 3 points. Muscle tone is increased according to the pyramidal type on the left up to 2.0 points on the Ashworth scale. Coordination tests: on the right - performs satisfactorily; on the left - performance is difficult due to paresis. Tendon reflexes in the upper and lower limbs S>D. Babinski's symptom (+) on the left. Hemihypesthesia on the left. Asthenic, emotionally labile. Controls pelvic functions.
[0024] Patient N. underwent a rehabilitation course consisting of a patient examination, physical stimulation of the auricular branch of the left vagus nerve, and subsequent rehabilitation training once a day for the duration of the rehabilitation course. Over the course of 5 days, the auricular branch of the left vagus nerve was stimulated with mono- and bipolar rectangular current pulses in burst-pause modulation mode using rectangular signals from a Mustang-PHYSIO-MELT-1K electrotherapeutic device for low-frequency pulsed currents manufactured by Technika LLC (Russia), operating in the "Transcutaneous Electrical Neurostimulation (TENS)" mode, followed by rehabilitation training.The first two days of exposure were performed with rectangular bipolar current pulses with a pulse repetition rate of 26 Hz, a current amplitude of 8.0 mA, a pulse duration of 0.5 ms, a modulating signal duration in the "pulse-pause" mode of 1.0 s, and a pause duration between pulses of 0.5 s. The following three days, exposure was performed with rectangular monopolar current pulses with a pulse repetition rate of 24 Hz, a current amplitude of 4.0 mA, a pulse duration of 0.3 ms, a modulating signal duration in the "pulse-pause" mode of 2.0 s, and a pause duration between pulses of 0.5 s. The duration of each procedure in the first two days was 10 minutes, in the following three days - 20 minutes. After each procedure, rehabilitation training was performed, which included exercises to train the movements of the paretic limb in accordance with clinical recommendations.
[0025] After the rehabilitation course, patient N. noted an improvement in her general well-being and mood; the range of active movements in the paretic limbs increased, muscle strength in the arm increased proximally to 4.5 points, and distally to 4 points.
[0026] After the rehabilitation course, the patient's overall well-being and mood improved; he became more active and mobile; the range of active movements in the paretic limbs increased, muscle strength in the upper limb increased to 4 points; and the hand's object-manipulation function indicators improved. Fine hand function assessment: ARAT scale: 30 points upon admission, 35 points upon discharge; Fugl-Meyer (FMA-UE) scale: 40 points upon admission, 48 points upon discharge. Hemodynamic parameters remained stable throughout the rehabilitation course.
[0027] At the State Budgetary Institution of the Rostov Region "Regional Clinical Hospital No. 2," 35 patients (18 women and 17 men), aged 32 to 67, who had suffered ischemic stroke with upper limb dysfunction, underwent rehabilitation using the stated method. As a result of the rehabilitation course, each of the 35 patients demonstrated improved upper limb function, which was confirmed by clinical examination. The rehabilitation period for each patient was 5 days.
[0028] Thus, the claimed method for rehabilitation of patients who have suffered a stroke is highly effective and, compared to the prototype, makes it possible to reduce the rehabilitation period of patients who have suffered an ischemic stroke with impaired upper limb function to 5 days.
Claims
A method for the rehabilitation of patients who have suffered an ischemic stroke with impairment of upper limb function, including: examination of the patient, exposure to the ear branch of the left vagus nerve with a physical factor followed by rehabilitation training once a day during the rehabilitation course, characterized in that the ear branch of the left vagus nerve is exposed for 5 days to rectangular mono- and bipolar current pulses in the "send-pause" mode by modeling rectangular signals of the Mustang-PHYSIO-MELT-1K electrotherapeutic device for exposure to low-frequency pulsed currents manufactured by OOO NPLC Tekhnika (Russia), operating in the "Transcutaneous electrical nerve stimulation (TENS)" mode according to the scheme: the first two days of the rehabilitation course, the impact is performed with rectangular bipolar current pulses with a pulse repetition rate of 26 Hz, a current amplitude of 8.0 mA, a pulse duration of 0.5 ms, duration of the modulating signal in the “message - pause” mode 1,0 s and a pause duration between pulse sendings of 0.5 s, the following three days of the course the impact is performed with rectangular monopolar current pulses with a pulse repetition frequency of 24 Hz, a current amplitude of 4.0 mA, a pulse duration of 0.3 ms, a modulating signal duration in the "pulse - pause" mode of 2.0 s and a pause duration between pulse sendings of 0.5 s; the duration of each procedure in the first two days is 10 min, in the next three days - 20 min; the rehabilitation course is 5 days.
Citation Information
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