Upper Limb Rehabilitation After Stroke Assisted With a Hybrid Electrical Stimulation (ES)-Robot System

Study Overview
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Brief Summary
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The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.

Official Title
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Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Device: Electrical Stimulation; Rehabilitation Robot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The recruited subjects will have unilateral ischemic brain injury or intracerebral hemorrhage at least 6 months after the onset of single stroke have moderate level of motor impairment in the affected upper limb, assessed by Fugl-Meyer Assessment (9<shoulder/elbow<27; 6<wrist/hand<18) have enough cognition to be able to follow the training protocol as assessed by Mini-metal State Examination (MMSE>21) have detectable EMG signals (3 times of the standard deviation above the baseline) from the upper limb muscles.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device-assisted rehabilitation<br> | Device: Electrical Stimulation; Rehabilitation Robot<br>* The recruited subjects will receive 20-session device assisted upper limb training with an intensity of 3 to 5 sessions/week, which will be finished within 7 consecutive weeks. In each session, the subjects will conduct the system assisted and task-oriented upper limb training for 1.5 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Assessment Scale after training | The Fugl-Meyer Assessment Scale for upper limb measures the voluntary motor function on the shoulder, the elbow, the wrist and hand. The full score ranges from 0 to 66. It can be further separated into two subscores, i.e., shoulder/elbow (0-42) and wrist/hand (0-24). The higher the score, the better is the related motor function. | 1) up to 7 weeks, 2) 3 months after participants finish the training | 
| Change in Modified Ashworth Scale after training | The Modified Ashworth Scale measures the resistance of a joint during passive motion, which indicates the muscle spasticity related to the joint motion, particularly the flexors. The Modified Ashworth Scale has six levels, i.e., 0, 1, 1+, 2, 3, 4. The higher value is related to a higher joint resistance, i.e., higher muscle spasticity. | 1) up to 7 weeks, 2) 3 months after participants finish the training |