EMG Training for Altering Activation Patterns After Stroke

NCT ID: NCT03619772

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Weakness, Muscle Coordination Lack

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bilateral

Participants will control game using EMG from both upper limbs.

Group Type EXPERIMENTAL

Bilateral

Intervention Type OTHER

Participants will control game using EMG from both upper limbs.

Unilateral

Participants will control game using the more impaired upper limb.

Group Type ACTIVE_COMPARATOR

Unilateral

Intervention Type OTHER

Participants will control game using EMG from the more impaired upper limb.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bilateral

Participants will control game using EMG from both upper limbs.

Intervention Type OTHER

Unilateral

Participants will control game using EMG from the more impaired upper limb.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Single, unilateral stroke at least 6 months prior to enrollment
* Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale

Exclusion Criteria

* Visual neglect or deficits (with inability to compensate)
* Upper extremity orthopedic conditions that interfere with movement
* Cerebellar stroke

Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Carolina State University

OTHER

Sponsor Role collaborator

Marquette University

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elliot Roth

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elliot Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22.

Reference Type DERIVED
PMID: 35320135 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00206747

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Marker for Stroke Recovery
NCT05256368 WITHDRAWN