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

N/AActive Not RecruitingNCT02117089

The Hong Kong Polytechnic University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Electrical Stimulation; Rehabilitation RobotDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Hong Kong Polytechnic University

Hong Kong, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1) up to 7 weeks, 2) 3 months after participants finish the training

Data from ClinicalTrials.gov

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