What this study is
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.
What's being tested
- MCI
Intervention · BEHAVIORAL
EMG-controlled game
- Sham MCI
Intervention · BEHAVIORAL
Sham control game
Study details
- Sponsor
- Northwestern University
- Conditions
- Stroke · Stroke, Acute
- Enrolling
- 96 people
- Starts
- 2018-01-15
- Est. completion
- 2027-04
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern University
Chicago, Illinois, United States
Recruiting
Study team
Sponsor
Northwestern University
Study ID STU00203644
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.