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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Stroke Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.

Study Groups

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Chronic stroke MCI Electromyogram (EMG) pairs

Decoupling 2 muscles at a time with MCI

Group Type EXPERIMENTAL

MCI

Intervention Type BEHAVIORAL

EMG-controlled game

Chronic stroke MCI EMG triplets

Decoupling 3 muscles at a time with MCI

Group Type EXPERIMENTAL

MCI

Intervention Type BEHAVIORAL

EMG-controlled game

Chronic stroke MCI while reaching

Decoupling muscles with MCI while reaching to targets

Group Type EXPERIMENTAL

MCI

Intervention Type BEHAVIORAL

EMG-controlled game

Chronic stroke Sham MCI

Sham control group

Group Type SHAM_COMPARATOR

Sham MCI

Intervention Type BEHAVIORAL

Sham control game

Acute stroke MCI

Decoupling muscles with MCI in acute stroke subjects

Group Type EXPERIMENTAL

MCI

Intervention Type BEHAVIORAL

EMG-controlled game

Acute stroke Sham MCI

Acute stroke subjects sham comparator

Group Type SHAM_COMPARATOR

Sham MCI

Intervention Type BEHAVIORAL

Sham control game

Interventions

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MCI

EMG-controlled game

Intervention Type BEHAVIORAL

Sham MCI

Sham control game

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No