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

Description

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

Chronic Stroke

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Stroke
Intervention / Treatment

-

Contacts and Locations

Cleveland

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States, 44106-1702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

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

Study Record Dates

2026-04-01