Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits

{ "Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits", "This study is looking at new ways to help people who have severe arm weakness due to a stroke that happened at least six months ago. It's testing if combining a special device called MyoPro with motor learning-based therapy works better than therapy alone. The MyoPro is a wearable device that uses signals from your weak arm muscles (electromyographic or EMG signals) to help you move your arm. You might be able to join if you are 18-89 years old, have arm weakness from a stroke, and can move your shoulder a certain amount. The study will measure success by looking at changes in your arm function using a score called the Fugl Meyer for Upper Limb (FM) over 24 weeks. The current status of this study is unclear, and it plans to enroll 60 participants.", "design": "This is an interventional study that plans to enroll 60 participants. It is a randomized controlled trial, meaning participants will be assigned by chance to receive either MyoPro with therapy or therapy alone.", "commitments": "You would participate in motor learning-based therapy, which includes functional task training and a home exercise program. The study will measure your arm function at weeks 1, 4, 9, 18, and 24.", "compensation": "Not stated in the trial record.", "follow_up": "Your arm function will be measured for up to 24 weeks after starting the intervention.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05296408

Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits

Recruiting
NAAges 18–89InterventionalTreatment
VA Office of Research and Development
~60 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:motor learning based therapyMyoProHome Exercise Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugl Meyer for Upper Limb (FM) change
Measured over weeks 1, 4, 9, 18 and 24
Chronic Stroke

NCT05296408

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Svetlana Pundik, MD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center, Cleveland, OH

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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.
  • Fugl Meyer for Upper Limb (FM) changeweeks 1, 4, 9, 18 and 24

    Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points) where higher scores represent better arm function.