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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03619772
Other study ID # STU00206747
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 28, 2018
Est. completion date October 31, 2022

Study information

Verified date May 2022
Source Shirley Ryan AbilityLab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date October 31, 2022
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Other:
Bilateral
Participants will control game using EMG from both upper limbs.
Unilateral
Participants will control game using EMG from the more impaired upper limb.

Locations

Country Name City State
United States Shirley Ryan AbilityLab Chicago Illinois

Sponsors (4)

Lead Sponsor Collaborator
Shirley Ryan AbilityLab Marquette University, Medical University of South Carolina, North Carolina State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean completion time for timed test Time to complete movement to 16 randomized targets Baseline and 3 weeks (immediately post intervention)
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