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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02117089
• Other study ID #: ITS/033/12
• Secondary ID: ITS/033/12
• Status: Recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Electrical Stimulation; Rehabilitation Robot
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.

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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