Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03401762

Collaborator

Shirley Ryan AbilityLab (Other), National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

66.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke.

Impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.

This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke, Acute	Behavioral: MCI Behavioral: Sham MCI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.

Primary Purpose:

Treatment

Official Title:

Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke

Actual Study Start Date :

Jan 15, 2018

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chronic stroke MCI Electromyogram (EMG) pairs Decoupling 2 muscles at a time with MCI	Behavioral: MCI EMG-controlled game
Experimental: Chronic stroke MCI EMG triplets Decoupling 3 muscles at a time with MCI	Behavioral: MCI EMG-controlled game
Experimental: Chronic stroke MCI while reaching Decoupling muscles with MCI while reaching to targets	Behavioral: MCI EMG-controlled game
Sham Comparator: Chronic stroke Sham MCI Sham control group	Behavioral: Sham MCI Sham control game
Experimental: Acute stroke MCI Decoupling muscles with MCI in acute stroke subjects	Behavioral: MCI EMG-controlled game
Sham Comparator: Acute stroke Sham MCI Acute stroke subjects sham comparator	Behavioral: Sham MCI Sham control game

Outcome Measures

Primary Outcome Measures

Wolf Motor Function Test [baseline to 6 weeks]
Timed

Secondary Outcome Measures

Fugl-Meyer Assessment - Upper Extremity (UE) [baseline to 6 weeks]
Motor Activity Log [baseline to 6 weeks]
Modified Ashworth Scale [baseline to 6 weeks]
Total score
Fugl-Meyer Assessment UE [baseline to 10 weeks]
Wolf Motor Function Test [baseline to 10 weeks]
Timed

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic stroke participants

Hemiparesis from first ever stroke at least 6 months prior to screening
Severe motor impairment (FMA of 7-30)
At least some voluntary shoulder and elbow muscle activation.

Acute stroke participants

Hemiparesis from first ever stroke within the past 14 days
Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors

Exclusion Criteria:

Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task
Visual impairment (such as hemianopia) preventing full view of the screen
Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).
Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
Inability to understand or follow commands in English due to aphasia or other reason
Diffuse or multifocal infarcts
Substantial arm pain preventing participation for 90 minutes a day
New spasticity treatment (pharmacological or Botox)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
Shirley Ryan AbilityLab
National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marc Slutzky, Associate Professor, Northwestern University

ClinicalTrials.gov Identifier:

NCT03401762

Other Study ID Numbers:

STU00203644

First Posted:

Jan 17, 2018

Last Update Posted:

Dec 13, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marc Slutzky, Associate Professor, Northwestern University

rehabilitation

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Dec 13, 2021