RECRUITINGINTERVENTIONAL
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
BEHAVIORAL
MCI
EMG-controlled game
BEHAVIORAL
Sham MCI
Sham control game
Locations (1)
Northwestern University
Chicago, Illinois, United States