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

April 16, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 underlying neurophysiological mechanisms of a novel approach to treat persistent severe arm deficits after stroke with a combination of MyoPro and motor learning-based therapy. The investigators will also estimate cost effectiveness of this therapeutic approach. Rationale: Motor learning-based therapy is one of the most effective stroke rehabilitation methods available, however its application is challenging for individuals with severe arm impairment because of their limited ability to practice volitional arm movement effectively. The MyoPro is an exoskeletal myoelectrically controlled orthotic device that is custom fitted to an individual's paretic arm and assists the user to move the paretic arm. MyoPro can help with motor learning-based therapy for individuals with severe motor deficits as it motivates practice because even weak muscle activity is translated into patient-initiated arm movement. Preliminary results of motor-learning therapy using MyoPro in the investigators' laboratory showed an increase in Fugl-Meyer for Upper extremity score (FM) of 7.4 points following 18 weeks of training (18 in-clinic therapy sessions over 9 weeks followed by 9 weeks of home practice) for chronic stroke survivors with baseline FM 30. However, comparison of the same dose of combination therapy with motor-learning alone remains to be determined. Study Design: Using a randomized, controlled design, individuals with chronic severe stroke ( 6 months post; Fugl Meyer UE score 30;n=60) will participate in either MyoPro+motor learning (M+ML) or motor learning alone (ML-alone). The study intervention will include 9 weeks of in-clinic training (18 sessions;1.5 hours each) followed by 9 weeks of home practice and a 6-week follow-up. Aim 1 is to determine whether M+ML results in greater treatment gains compared to ML-alone. The primary outcome will be change in FM. Secondary outcome measures will assess overall paretic arm performance and will include: kinematics, muscle tone (Modified Ashworth Scale; MAS), grip/pinch/arm dynamometry, sensory function (Semmes Weinstein mono-filament test, joint proprioception), arm function (Arm Motor Ability Test (AMAT);actigraphy) and quality of life (Stroke Impact Scale (SIS)). Aim 2 is to characterize structural and functional brain changes after treatment. Outcomes include corticospinal excitability (motor evoked potential recruitment curve (MEP-rc)), and functional connectivity (resting state function Magnetic Resonance Imaging(rs-fMRI). Aim 3 is to identify baseline factors associated with greater functional improvement with treatment. Outcomes are as follows: baseline integrity of the stroke-affected corticospinal tract (lesion load, MEP-rc; Diffusion Tensor Imaging); baseline motor ability of the affected arm (FM); baseline functional connectivity (rs-fMRI); device usage and actigraphy. Aim 4 is to evaluate cost effectiveness of M+ML versus ML-alone. Outcomes include: direct/indirect costs and health related quality of life surveys (Short Form 12v.2 and SIS). Significance: This study will address an important problem for the VA patient population by testing for the first time whether MyoPro combined with motor learning-based therapy is superior to motor learning alone in the treatment of chronic, severe arm impairment in stroke. If found to be effective, the study intervention is readily deployable to the clinical setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-1702
        • Recruiting
        • Louis Stokes VA Medical Center, Cleveland, OH
        • Contact:
        • Principal Investigator:
          • Svetlana Pundik, MD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: M+ML
MyoPro paired with motor learning based therapy
Behavioral: motor learning based therapy
Motor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progressed according to a motor control hierarchy to ensure adequate challenge. Training is always started at the appropriate level of challenge for an individual to ensure adequate challenge is delivered whether the individual is higher or lower functioning.
Behavioral: MyoPro
The MyoPro supports motor learning-based training by reinforcing coordinated movement practice, allowing for finely incrementalized training progression, and encouraging high repetition of movement. Importantly, the device assists the user to move the paretic limb in a manner they may otherwise be unable to do. This further motivates the user to continue attempts to move the paretic limb. When a user attempts to volitionally contract a weak muscle, sensors embedded within the MyoPro detect the EMG signal, which triggers activation of a motor within the device. The motor assists the user to complete the desired movement (e.g. opening of the hand).Subjects experience real-time biofeedback through their ability to sense and see movement of the target joint(s) and via their interface with the software on a computer that provides visual feedback of the EMG level of the contracting muscle
Behavioral: Home Exercise Program
Every subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals will log practice time. The HEP for M+ML will include practice with and without the MyoPro; the HEP for ML-alone will include practice without MyoPro. Each HEP session will require approximately 90 minutes to complete.
Active Comparator: ML-alone
motor learning based therapy alone
Behavioral: motor learning based therapy
Motor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progressed according to a motor control hierarchy to ensure adequate challenge. Training is always started at the appropriate level of challenge for an individual to ensure adequate challenge is delivered whether the individual is higher or lower functioning.
Behavioral: Home Exercise Program
Every subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals will log practice time. The HEP for M+ML will include practice with and without the MyoPro; the HEP for ML-alone will include practice without MyoPro. Each HEP session will require approximately 90 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fugl Meyer for Upper Limb (FM) change
Time Frame: weeks 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.
weeks 1, 4, 9, 18 and 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: weeks 1, 4, 9, 18, 24
MAS will be used to assess muscle tone. Using a 5-point scale, resistance to passive movement about a joint with is scored. MAS has been widely used to quantify muscle tone following stroke. MAS of the shoulder internal rotators, elbow flexors/extensors, forearm pronators/supinators, wrist flexors/extensors and finger flexors/extensors will be scored.
weeks 1, 4, 9, 18, 24
Upper limb kinematics
Time Frame: weeks 1, 4, 9, 18, 24
The investigators will use a 3-D optic motion analysis (Vicon) system to assess participants' movement performance during supported forward reach and a forward reach to grasping task. Kinematic variables to be assessed will include joint range of motion used to perform the task and end-point trajectory.
weeks 1, 4, 9, 18, 24
Dynamometry
Time Frame: weeks 1, 4, 9, 18, 24
Muscle force production of the elbow flexors/extensors and wrist flexors/extensors will be assessed using standardized hand-held dynamometry.
weeks 1, 4, 9, 18, 24
Arm Motor Ability Test
Time Frame: weeks 1, 4, 9, 18, 24
AMAT tests the time and quality of performance of 13 different complex tasks of activities of daily living (ADL). Rating is based on the quality of movement, ability to complete the task and time elapsed.
weeks 1, 4, 9, 18, 24
Stroke Impact Scale
Time Frame: weeks 1, 4, 9, 18, 24
The SIS is a self-report measure that evaluates disability and health related quality of life across 8 domains for individuals with stroke.
weeks 1, 4, 9, 18, 24
Transcranial Magnetic Stimulation (TMS)
Time Frame: weeks 1, 4, 9, 18, 24
motor evoked potentials will be recorded at stimulator output (SO) intensities ranging from those that evoke no response above baseline activity to those that evoke a maximal response. SO will be increased until the MEP amplitude plateaus, or the maximum SO (100%) is reached.
weeks 1, 4, 9, 18, 24
Brain network connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI)
Time Frame: week 1 and 18
Functional connectivity within the Sensory Motor network (SMN) and Default Mode Network (DMN) will be computed based on resting state functional Magnetic Resonance Imaging (rs-fMRI). SMN and DMN network connectivity matrices will be computed using anatomical regions defined in the automated anatomical labelling (AAL) atlas. The mean time course from each region will be extracted and Pearson correlation will be computed.
week 1 and 18
Short Form 12v12
Time Frame: weeks 1, 9, 18, 24
SF 12v12 is a self report questionnaire that measures health related quality of life.
weeks 1, 9, 18, 24
Fractional anisotropy of movement-related tracts
Time Frame: week 1 and 18
FA will computed for bilateral motor output tracts by fitting a tensor model at each voxel and then be assessed within the non-lesion portion of a white matter tract.
week 1 and 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Svetlana Pundik, MD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N3674-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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