Upper Limb Rehabilitation After Stroke Assisted With a Hybrid Electrical Stimulation (ES)-Robot System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02117089|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2014
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Electrical Stimulation; Rehabilitation Robot||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomechatronic System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
|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.
- Change in Fugl-Meyer Assessment Scale after training [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117089
|The Hong Kong Polytechnic University|
|Hong Kong, China|
|Principal Investigator:||Xiaoling Hu, Ph.D.||The Hong Kong Polytechnic University|