Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
2026年7月31日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xiaoling Hu, Phd
- 電話番号：852 3400 3206
- メール：xiaoling.hu@polyu.edu.hk
研究場所
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Kowloon
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Hung Hom、Kowloon、香港
- 募集
- The Hong Kong Polytechnic University
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コンタクト：
- Xiaoling Hu, Phd
- 電話番号：852 3400 3206
- メール：mailxiaoling.hu@polyu.edu.hk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
時間枠：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.
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
時間枠：At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
|
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)
時間枠：At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
|
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)
時間枠：At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
|
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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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EMG Co-contraction Index During Wrist-Hand Tasks
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年1月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年7月27日
QC基準を満たした最初の提出物
2026年7月27日
最初の投稿 (実際)
2026年7月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月31日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。