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

Not Applicable

Recruiting

• Conditions: Stroke, Acute; Stroke
• Interventions: Behavioral: MCI; Behavioral: Sham MCI

• Registration Number: NCT03401762
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study Start: 2018-01-15
• Study First Posted: 2018-01-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic stroke MCI Electromyogram (EMG) pairs	MCI	Decoupling 2 muscles at a time with MCI
Chronic stroke Sham MCI	Sham MCI	Sham control group
Chronic stroke MCI while reaching	MCI	Decoupling muscles with MCI while reaching to targets
Acute stroke Sham MCI	Sham MCI	Acute stroke subjects sham comparator
Chronic stroke MCI EMG triplets	MCI	Decoupling 3 muscles at a time with MCI
Acute stroke MCI	MCI	Decoupling muscles with MCI in acute stroke subjects

Primary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	baseline to 6 weeks	Timed

Secondary Outcome Measures

Name	Time	Method
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	Total score
Wolf Motor Function Test	baseline to 10 weeks	Timed

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States