NCT05296408Recruiting
Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Mar 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Stroke
- NCT number
- NCT05296408
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2022 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous stroke(s) affecting motor function on the opposite side.
- Currently taking medications or substances that lower the threshold for onset of seizure.
Other illness
- Past history of seizures
- Family history of medication refractory epilepsy
Other
- 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).
- Pregnancy or pregnancy planning during the study period
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.