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

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02117089
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Duration (Months): 122
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Electrical Stimulation; Rehabilitation Robot	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation
• Study Start Date: Oct 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device-assisted rehabilitation	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hong Kong Polytechnic University	Hong Kong		China

Sponsors and Collaborators

• The Hong Kong Polytechnic University

Investigators

• Principal Investigator: Xiaoling Hu, Ph.D., The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaoling Hu, Doctor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT02117089
• Other Study ID Numbers: ITS/033/12; ITS/033/12
• First Posted: Apr 17, 2014
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Aug 24, 2022