Status:
RECRUITING
Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Stroke
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic...
Detailed Description
Current rehabilitation methods fail to restore normal arm function for many stroke survivors, particularly those with severe deficits. The main objective of this study is to test efficacy and evaluate...
Eligibility Criteria
Inclusion
- 18-89 years of age
- Unilateral arm weakness due to stroke (6 months or more since onset)
- Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
- Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
- Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the MyoPro software
- MAS score less or equal to 3 for the biceps, triceps, supinators and pronators of the impaired arm
- Able to read and comprehend the English language
- Able to follow directions
- Able to provide informed consent
- Medically and psychologically stable.
- Ability to don/doff MyoPro independently or have support as needed.
- Ability to undergo MRI
- Ability to undergo TMS procedures
Exclusion
- Previous stroke(s) affecting motor function on the opposite side.
- Persistent and severe shoulder subluxation, pain or dislocation
- Shoulder passive range of motion \< 45 degrees in flexion and abduction
- Fixed upper limb contractures on the impaired arm and hand
- Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
- Skin rash or open non-healing wound on impaired arm
- Involuntary movements of the impaired arm
- Pacemaker or other implanted devices that are not compatible with testing procedures or would interfere with donning/doffing and functioning of device.
- Metal in the skull or deformity of the skull
- Claustrophobia, or inability to operate the MRI patient call button
- Contraindications for MRI (standardized screening form for MRI).
- Past history of seizures
- Family history of medication refractory epilepsy
- Pregnancy or pregnancy planning during the study period
- Currently taking medications or substances that lower the threshold for onset of seizure.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05296408
Start Date
April 1 2022
End Date
April 1 2026
Last Update
June 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702