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

31 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

48

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Aktywny komparator: 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.
Urządzenie: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Ramy czasowe
EMG Co-contraction Index During Wrist-Hand Tasks
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Hong Kong Polytechnic University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2025

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

27 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 lipca 2026

Pierwszy wysłany (Rzeczywisty)

30 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • GRF15218324

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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