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

31. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

48

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Hongkong
    • Kowloon
      • Hung Hom, Kowloon, Hongkong
        • Nábor
        • The Hong Kong Polytechnic University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. at least 6 months after the onset of a unilateral lesion due to stroke;
  2. 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);
  3. sensory impairment on their affected forearm with a score of 1 measured by the sensation part of light touch in the FMA;
  4. 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);
  5. sufficient cognition to follow experimental instructions (Mini-Mental State Examination score >21);
  6. aged from 30 to 70 years.

Exclusion Criteria:

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Aktivní komparátor: 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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
Časové okno: 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 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
Časové okno: 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.
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)
Časové okno: 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.
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)
Časové okno: 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.
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
Časové okno: 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 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.
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
Časové okno: 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 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.
At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

Další výstupní opatření

Měření výsledku
Časové okno
EMG Co-contraction Index During Wrist-Hand Tasks
Časové okno: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
Dynamic Neuromuscular Network Functional Connectivity
Časové okno: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
Peak Beta-Band Corticomuscular Coherence Value
Časové okno: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
Cortical Location of Peak Beta-Band Corticomuscular Coherence
Časové okno: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Hong Kong Polytechnic University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2025

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

27. července 2026

První předloženo, které splnilo kritéria kontroly kvality

27. července 2026

První zveřejněno (Aktuální)

30. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GRF15218324

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