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New treatment option for Stroke
Official title Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
ClinicalTrials.gov ID: NCT03401762
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.