EMG Controlled Device in Acute Rehabilitation After Acute Stroke

May 12, 2026 updated by: VA Office of Research and Development

Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke

Stroke is a medically relevant problem for the aging population. Individuals with stroke experience a high amount of arm functional deficits despite receiving rehabilitation. Functional deficits can be improved by combining rehabilitation with innovative rehabilitative tools that target the brain mechanisms that guide the recovery early after stroke. This study aims to explore the feasibility of implementing an EMG controlled device in the acute rehabilitation for stroke survivors with severe arm deficit. This study will determine if adding such a technology improve the clinical outcomes for subjects with severe arm impairments beyond the levels achieved by standard care in attempt to increase their chances to independently perform activities of daily living.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

During the first weeks after the onset of stroke, the injured brain undergoes several neural mechanisms, a process known as neuroplasticity, that intend to reorganize the neural connectivity and repair the damaged tissue around the injury region. Several studies revealed that rehabilitation during this acute period of injury would enhance the functional outcome of the paretic arm presumably by modulating the heightened neuroplastic mechanism. Specifically, it has been suggested that novel interventions that interact with the neuroplastic mechanisms of recovery are particularly needed for stroke survivors whom initial arm impairments are severe.

The rationale of this study is to explore if an EMG controlled device can be added to the acute rehabilitation for stroke subjects with severe arm deficit. The study will also investigate if the application of such a device would lead to an even better enhancement of clinical outcomes compared to standard care. Because of such neurophysiological changes during the acute phase, the study aims to correlate the neurophysiological changes with the enhancement gained as a result of practicing with an EMG controlled device in this population. Thus, test the premise that adding practice with an EMG controlled device to the acute rehabilitation of subjects with severe arm impairments acts as novel rehabilitative tool that interact with the neuroplastic mechanisms of recovery to enhance clinical outcomes for these subjects.

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 (Actual)

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.
3

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
        • Louis Stokes VA Medical Center, Cleveland, OH

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Veterans over 18 years of age
  • 2 days to 6 months since the onset of ischemic stroke
  • Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device.
  • 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 3 for the biceps, triceps, supinators and pronators of the impaired arm
  • Able to read and comprehend the English language
  • Able to follow directions
  • Medically and psychologically stable.

Healthy Controls:

Over 18 years of age No history of neurological or muscular problems that affect arm function

Exclusion Criteria:

Hemorrhagic stroke

  • Previous strokes affecting motor function on the opposite side.

  • Fugl-Meyer score of 2 on the following 3 items:

    1) finger mass extension, 2) grasp #1 test, and 3) shoulder flexion 90 - 180 degrees, elbow at 0 degree, and forearm neutral.

  • 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 wound on impaired arm
  • Involuntary movements of the impaired arm
  • Pacemaker or other implanted devices
  • Metal in the skull
  • Claustrophobia, or inability to operate the MRI patient call button
  • Past history of seizures
  • Family history of medication refractory epilepsy
  • Chronic sleep deprivation, ongoing untreated sleep disorder
  • Pregnancy or pregnancy planning during the study period
  • Currently taking medications or substances that lower the threshold for onset of seizure.
  • Inability to understand English

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Feasibility
To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.
Device: MARK
EMG controlled arm orthosis

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
Changes in arm impairment using Fugl-Meyer assessment (FMA)
Time Frame: Change from Baseline arm impairment after 6 weeks
Measure of arm impairment. Scores on the FMA may range from 0-66 points, with higher score indicating better performance.
Change from Baseline arm impairment after 6 weeks

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
Changes in arm function using Action Research Arm Test (ARAT)
Time Frame: Change from Baseline arm function after 6 weeks
Measure of arm function. Scores on the ARAT may range from 0-57 points, with higher score indicating better performance.
Change from Baseline arm function after 6 weeks

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: Ahlam Salameh, PhD MSc, 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.
October 7, 2020

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.
September 30, 2026

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.
September 30, 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).
October 9, 2020

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.
October 16, 2020

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.
October 22, 2020

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.
May 15, 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.
May 12, 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.
May 1, 2026

More Information

Terms related to this study

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.
  • B3554-M

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

Yes

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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