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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03401762
• Other study ID #: STU00203644
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: Marc W Slutzky, MD, PhD
• Phone: 3125034653
• Email: mslutzky[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Behavioral:
• MCI
EMG-controlled game
• Sham MCI
Sham control game

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institutes of Health (NIH), Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor Function Test	Timed	baseline to 6 weeks
Secondary	Fugl-Meyer Assessment - Upper Extremity (UE)		baseline to 6 weeks
Secondary	Motor Activity Log		baseline to 6 weeks
Secondary	Modified Ashworth Scale	Total score	baseline to 6 weeks
Secondary	Fugl-Meyer Assessment UE		baseline to 10 weeks
Secondary	Wolf Motor Function Test	Timed	baseline to 10 weeks