Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

Study Overview
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Brief Summary
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A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.

Detailed Description
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A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user. The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.

Official Title
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Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

Conditions
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Upper Limb Rehabilitation

Intervention / Treatment
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* Device: Robot assisted upper limb rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the subacute groups: Two weeks after the onset of stroke, however less than 0.5 year Mini-Mental State Examination (MMSE)>21 Able to sit up for at least 1 hour Fugl-Meyer Assessment (FMA) upper limb <30 Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3 Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline) For the chronic device assisted group: At least 0.5 year after the onset of stroke Mini-Mental State Examination (MMSE)>21 Able to sit up for at least 1 hour Fugl-Meyer Assessment (FMA) upper limb <30 Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3 Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline) Exclusion Criteria: Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions: Currently pregnant Dysphasia (language deficiency) 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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subacute device assisted group<br> | Device: Robot assisted upper limb rehabilitation<br>* The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.<br>|
| Active Comparator: subacute conventional group<br> | Device: Robot assisted upper limb rehabilitation<br>* The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.<br>|
| Other: chronic device assisted group<br> | Device: Robot assisted upper limb rehabilitation<br>* The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) of the Upper Limb before the training |  | For each subject, the FMA score will be measured one day before the training. | 
| Fugl-Meyer Assessment (FMA) of the Upper Limb after the training |  | For each subject, the FMA score will be measured one day after the 20-session training program. | 
| Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up |  | For each subject, the FMA score will be measured 3 months later after the last day of the training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale (MAS) |  | For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training. | 
| Action Research Arm Test (ARAT) |  | For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, upper limb, Joint coordination