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

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ClinicalTrials.gov Identifier: NCT02117089
Recruitment Status : Active, not recruiting
First Posted : April 17, 2014
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoling Hu, 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.

Condition or disease Intervention/treatment Phase
Stroke Device: Electrical Stimulation; Rehabilitation Robot Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China
The Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Xiaoling Hu, Ph.D. The Hong Kong Polytechnic University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaoling Hu, Doctor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02117089     History of Changes
Other Study ID Numbers: ITS/033/12
ITS/033/12 ( Other Grant/Funding Number: Innovation and Technology Commission of Hong Kong )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases