Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
2026년 7월 31일 업데이트: Xiaoling Hu, The Hong Kong Polytechnic University
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.
연구 개요
연구 유형
중재적
등록 (추정된)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xiaoling Hu, Phd
- 전화번호: 852 3400 3206
- 이메일: xiaoling.hu@polyu.edu.hk
연구 장소
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Kowloon
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Hung Hom, Kowloon, 홍콩
- 모병
- The Hong Kong Polytechnic University
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연락하다:
- Xiaoling Hu, Phd
- 전화번호: 852 3400 3206
- 이메일: mailxiaoling.hu@polyu.edu.hk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Closed-Loop Sensorimotor Integrated Group
Participants will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton (ENMS).
In this group, corticomuscular coherence (CMC) and electromyographic (EMG) signals will be used together to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.
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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.
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활성 비교기: EMG-Driven Group
Participants will receive 20 sessions of wrist-hand rehabilitation using the same exoneuromusculoskeleton (ENMS).
In this group, electromyographic (EMG) activity alone will be used to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.
|
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
기간: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Fugl-Meyer Assessment Wrist and Hand Subscore (FMA-WH) evaluates motor impairment of the paretic wrist and hand after stroke.
The score ranges from 0 to 24, including a maximum of 10 points for wrist function and 14 points for hand function.
Higher scores indicate better wrist-hand motor function.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
기간: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers.
Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Wrist Spasticity Assessed by the Modified Ashworth Scale (MAS)
기간: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers.
Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Elbow Spasticity Assessed by the Modified Ashworth Scale (MAS)
기간: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers.
Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Fugl-Meyer Assessment Shoulder/Elbow Subscale Score
기간: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Fugl-Meyer Assessment Shoulder/Elbow Subscore evaluates proximal upper-extremity motor impairment, including movements of the shoulder, elbow, and forearm.
The score ranges from 0 to 36.
Higher scores indicate better proximal upper-extremity motor function.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Action Research Arm Test (ARAT) Score
기간: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Action Research Arm Test (ARAT) evaluates upper-extremity activity performance through 19 items covering grasp, grip, pinch, and gross movement.
The total score ranges from 0 to 57.
Higher scores indicate better upper-extremity activity performance.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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EMG Co-contraction Index During Wrist-Hand Tasks
기간: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Dynamic Neuromuscular Network Functional Connectivity
기간: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Peak Beta-Band Corticomuscular Coherence Value
기간: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Cortical Location of Peak Beta-Band Corticomuscular Coherence
기간: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 1월 1일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 27일
QC 기준을 충족하는 최초 제출
2026년 7월 27일
처음 게시됨 (실제)
2026년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 31일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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