Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
Overview
- Phase
- N/A
- Intervention
- MCI
- Conditions
- Stroke
- Sponsor
- Northwestern University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Wolf Motor Function Test
- Status
- Recruiting
- Last Updated
- 24 days ago
Overview
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.
Investigators
Marc Slutzky
Associate Professor
Northwestern University
Eligibility Criteria
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)
Arms & Interventions
Chronic stroke MCI Electromyogram (EMG) pairs
Decoupling 2 muscles at a time with MCI
Intervention: MCI
Chronic stroke MCI EMG triplets
Decoupling 3 muscles at a time with MCI
Intervention: MCI
Chronic stroke MCI while reaching
Decoupling muscles with MCI while reaching to targets
Intervention: MCI
Chronic stroke Sham MCI
Sham control group
Intervention: Sham MCI
Acute stroke MCI
Decoupling muscles with MCI in acute stroke subjects
Intervention: MCI
Acute stroke Sham MCI
Acute stroke subjects sham comparator
Intervention: Sham MCI
Outcomes
Primary Outcomes
Wolf Motor Function Test
Time Frame: baseline to 6 weeks
Timed
Secondary Outcomes
- Fugl-Meyer Assessment UE(baseline to 10 weeks)
- Fugl-Meyer Assessment - Upper Extremity (UE)(baseline to 6 weeks)
- Motor Activity Log(baseline to 6 weeks)
- Modified Ashworth Scale(baseline to 6 weeks)
- Wolf Motor Function Test(baseline to 10 weeks)