Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 21 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Northwestern University
Chicago, Illinois 60611

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Marc W Slutzky, MD, PhD
3125034653
mslutzky@northwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.