Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
31 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Xiaoling Hu, Phd
- Telefoonnummer: 852 3400 3206
- E-mail: xiaoling.hu@polyu.edu.hk
Studie Locaties
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Kowloon
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Hung Hom, Kowloon, Hongkong
- Werving
- The Hong Kong Polytechnic University
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Contact:
- Xiaoling Hu, Phd
- Telefoonnummer: 852 3400 3206
- E-mail: mailxiaoling.hu@polyu.edu.hk
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
Tijdsspanne: 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.
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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EMG Co-contraction Index During Wrist-Hand Tasks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2025
Primaire voltooiing (Geschat)
31 december 2027
Studie voltooiing (Geschat)
31 december 2027
Studieregistratiedata
Eerst ingediend
27 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 juli 2026
Eerst geplaatst (Werkelijk)
30 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
31 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GRF15218324
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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