Stroke, Stroke, Acute
Conditions
Keywords
rehabilitation
Brief 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.
Interventions
EMG-controlled game
Sham control game
Sponsors
Study design
Masking description
Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | baseline to 6 weeks | Timed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity (UE) | baseline to 6 weeks | — |
| Motor Activity Log | baseline to 6 weeks | — |
| Modified Ashworth Scale | baseline to 6 weeks | Total score |
| Fugl-Meyer Assessment UE | baseline to 10 weeks | — |
| Wolf Motor Function Test | baseline to 10 weeks | Timed |
Countries
United States