Actively Recruiting
Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
Led by VA Office of Research and Development · Updated on 2026-04-21
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.
CONDITIONS
Official Title
Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 89 years
- Unilateral arm weakness caused by stroke at least 6 months ago
- Adequate range of motion in elbow, forearm, wrist, and hand to wear the device
- Active shoulder flexion of at least 30 degrees and abduction of at least 20 degrees
- Ability to produce consistent muscle signals detectable by the MyoPro device
- Muscle tone score (MAS) of 3 or less in affected arm muscles
- Ability to read, understand English, and follow directions
- Able to give informed consent
- Medically and psychologically stable
- Ability to put on and take off the MyoPro device independently or with support
- Able to undergo MRI and TMS procedures
You will not qualify if you...
- Previous stroke affecting motor function on the opposite side
- Severe shoulder problems such as persistent subluxation, pain, or dislocation
- Shoulder passive range of motion less than 45 degrees in flexion and abduction
- Fixed contractures in the affected arm and hand
- Unable to support arm weight plus 4 lbs without pain even when supported
- Skin rash or open wound on affected arm
- Involuntary movements of the affected arm
- Implanted devices incompatible with testing or device use
- Metal or deformity in the skull
- Claustrophobia or inability to use MRI call button
- Contraindications for MRI
- History of seizures or family history of epilepsy that does not respond to medication
- Pregnancy or planning pregnancy during the study
- Taking medications or substances that increase seizure risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
Research Team
J
Jessica P McCabe, MPT DPT
CONTACT
S
Svetlana Pundik, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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