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

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Electrical Stimulation; Rehabilitation Robot

• Registration Number: NCT02117089
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-09
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device-assisted rehabilitation	Electrical Stimulation; Rehabilitation Robot	-

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment Scale after training	1) up to 7 weeks, 2) 3 months after participants finish the 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.
Change in Modified Ashworth Scale after training	1) up to 7 weeks, 2) 3 months after participants finish the 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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇨🇳 Hong Kong, China