Using a wearable device to improve arm movement after stroke
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
NA · Northwestern University · NCT03401762
This study is testing a special device that helps stroke survivors improve their arm movement at home to see if it works better than a fake device.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT03401762 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility of a myoelectric-computer interface (MCI) designed to enhance arm movement in individuals who have experienced a stroke. It addresses the issue of impaired coordination caused by abnormal muscle co-activation, which affects recovery. Participants will use the MCI at home, and the study will compare its effects against a sham device in both chronic and acute stroke survivors. The study employs a randomized, controlled, and blinded design to ensure reliable results.
Who should consider this trial
Good fit: Ideal candidates include individuals with hemiparesis from their first stroke, either chronic (at least 6 months post-stroke) or acute (within the past 21 days), who exhibit severe motor impairment.
Not a fit: Patients with cognitive or visual impairments that prevent them from following instructions or fully engaging with the MCI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve arm mobility and rehabilitation outcomes for stroke survivors.
How similar studies have performed: While the use of wearable devices in rehabilitation is an emerging field, this specific approach using MCI for muscle co-activation in stroke patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Marc W Slutzky, MD, PhD
- Email: mslutzky@northwestern.edu
- Phone: 3125034653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Stroke, Acute, rehabilitation