Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
31 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
48
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Xiaoling Hu, Phd
- Numero di telefono: 852 3400 3206
- Email: xiaoling.hu@polyu.edu.hk
Luoghi di studio
-
-
Kowloon
-
Hung Hom, Kowloon, Hong Kong
- Reclutamento
- The Hong Kong Polytechnic University
-
Contatto:
- Xiaoling Hu, Phd
- Numero di telefono: 852 3400 3206
- Email: mailxiaoling.hu@polyu.edu.hk
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
EMG Co-contraction Index During Wrist-Hand Tasks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2025
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
27 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
27 luglio 2026
Primo Inserito (Effettivo)
30 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GRF15218324
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .