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

Northwestern University

Status: Enrolling

Conditions: Stroke; Stroke, Acute

Treatments: Behavioral: MCI; Behavioral: Sham MCI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03401762

STU00203644

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 6 patient groups

Chronic stroke MCI Electromyogram (EMG) pairs

Experimental group

Description:

Decoupling 2 muscles at a time with MCI

Treatment:

Behavioral: MCI

Chronic stroke MCI EMG triplets

Experimental group

Description:

Decoupling 3 muscles at a time with MCI

Treatment:

Behavioral: MCI

Chronic stroke MCI while reaching

Experimental group

Description:

Decoupling muscles with MCI while reaching to targets

Treatment:

Behavioral: MCI

Chronic stroke Sham MCI

Sham Comparator group

Description:

Sham control group

Treatment:

Behavioral: Sham MCI

Acute stroke MCI

Experimental group

Description:

Decoupling muscles with MCI in acute stroke subjects

Treatment:

Behavioral: MCI

Acute stroke Sham MCI

Sham Comparator group

Description:

Acute stroke subjects sham comparator

Treatment:

Behavioral: Sham MCI