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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Stroke, Acute

Intervention / Treatment
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* Behavioral: MCI
* Behavioral: Sham MCI


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test | Timed | baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - Upper Extremity (UE) |  | baseline to 6 weeks | 
| Motor Activity Log |  | baseline to 6 weeks | 
| Modified Ashworth Scale | Total score | baseline to 6 weeks | 
| Fugl-Meyer Assessment UE |  | baseline to 10 weeks | 
| Wolf Motor Function Test | Timed | baseline to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation