Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke

Обзор

The goal of this randomized controlled trial is to determine whether using both brain and muscle signals to control a wrist-hand rehabilitation robot can improve recovery in people with chronic stroke. A total of 48 participants will be randomly assigned to one of two groups. Both groups will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton rehabilitation robot. In the closed-loop sensorimotor integrated group, the system will use information from both brain-muscle coordination and muscle activity to recognize the participant's movement intention and provide electrical stimulation and robotic assistance. In the electromyography-driven group, the system will use muscle activity alone to control the electrical stimulation and robotic assistance. The main questions this study aims to answer are: Does control using both brain and muscle signals improve wrist and hand motor function more than control using muscle signals alone? Does this approach produce greater changes in coordination between the brain and muscles? Participants will complete motor-function and brain-muscle assessments before training, immediately after the 20 training sessions, and 3 months after training.

Вмешательства

• Устройство CSMI-Controlled ENMS
  The exoneuromusculoskeleton (ENMS) provides neuromuscular electrical stimulation and robotic assistance for wrist-hand rehabilitation. In the CSMI-controlled intervention, corticomuscular coherence and electromyographic signals are jointly used to identify voluntary movement intention and trigger assistance. Participants will receive 20 training sessions.
• Устройство EMG-Driven ENMS
  The exoneuromusculoskeleton (ENMS) provides neuromuscular electrical stimulation and robotic assistance for wrist-hand rehabilitation. In the EMG-driven intervention, electromyographic activity alone is used to identify voluntary movement intention and trigger assistance. Participants will receive 20 training sessions.

Первичные конечные точки

• Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score [Срок оценки: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training]

Вторичные конечные точки (5)

• Finger Spasticity Assessed by the Modified Ashworth Scale (MAS) [Срок оценки: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training]
• Wrist Spasticity Assessed by the Modified Ashworth Scale (MAS) [Срок оценки: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training]
• Elbow Spasticity Assessed by the Modified Ashworth Scale (MAS) [Срок оценки: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training]
• Fugl-Meyer Assessment Shoulder/Elbow Subscale Score [Срок оценки: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training]
• Action Research Arm Test (ARAT) Score [Срок оценки: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training]

Критерии участия

Критерии включения

• at least 6 months after the onset of a unilateral lesion due to stroke;
• moderate to severe motor disability in the paretic wrist-hand joints (6<Fugl-Meyer Wrist-Hand Assessment (FMAWH)<14) and spasticity in wrist-hand (Modified Ashworth Score (MAS) ≤3);
• sensory impairment on their affected forearm with a score of 1 measured by the sensation part of light touch in the FMA;
• maximal voluntary contraction (MVC) with detectable EMG (3 times of the standard deviation above the resting EMG baseline) in the muscle union of the flexor digitorum and flexor carpi radialis (FD-FCR) and that of the extensor digitorum and extensor carpi ulnaris (ED-ECU);
• sufficient cognition to follow experimental instructions (Mini-Mental State Examination score >21);
• aged from 30 to 70 years.

Критерии исключения

• currently pregnant;
• dysphasia (language deficiency);
• skull implantation;
• post-stroke neglect;
• pacemaker implantation;
• involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb;
• the overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Hung Hom

Идентификаторы

NCT: NCT07737431 · GRF15218324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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