No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for people who have had a stroke to test a wearable device that may help improve arm movement. Participants will use the device at home to see if it can help reduce problems with muscle coordination.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke at least 6 months ago or within the past 21 days.
I have severe difficulty moving my arm.
I can move my shoulder and elbow muscles at least a little.
You may not be able to join if
I have trouble paying attention or can't follow instructions.
I have vision problems that prevent me from seeing a screen.
I cannot feel my affected arm.
I have participated in another study for my affected arm in the last 6 weeks.
I can’t understand or follow commands in English.
I have widespread or multiple areas of brain damage.
I have significant pain in my arm that stops me from participating.
I have recently started treatment for muscle tightness.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 b…
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.
Trial Locations
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Status
Eligibility 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 …
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)
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