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EMG-Controlled Device for Stroke Rehabilitation

N/A
Recruiting
Led By Ahlam Salameh, PhD MSc
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device
Be older than 18 years old
Must not have
Family history of medication refractory epilepsy
Previous strokes affecting motor function on the opposite side
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline arm impairment after 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a brain-controlled device can help improve arm function in people who have had a stroke, beyond what is achievable with standard rehabilitation.

Who is the study for?
This trial is for veterans over 18 who've had an ischemic stroke within the last 6 months, can understand English, and follow directions. They should be medically stable with a certain level of muscle stiffness in their arm but able to move it enough to wear a device. They must not have severe arm contractures, involuntary movements, or conditions that could interfere with the study.
What is being tested?
The trial tests if using an EMG controlled device during early rehabilitation helps stroke survivors with severe arm deficits improve more than standard care alone. The goal is to see if this technology increases their ability to perform daily activities independently.
What are the potential side effects?
Potential side effects are not explicitly listed for this intervention; however, participants may experience discomfort or fatigue from using the EMG controlled device as part of therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can move my elbow, forearm, wrist, and hand well enough to wear a device.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My family has a history of epilepsy that doesn't respond well to medication.
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I have had a stroke that affected my ability to move the opposite side of my body.
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I can't lift my arm sideways or in front above shoulder level.
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I have stiff joints in my arm and hand that I cannot fully straighten.
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I have had a bleeding stroke.
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I am taking medication that could increase my risk of seizures.
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I have long-term sleep problems that haven't been treated.
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I cannot hold my arm up with an extra 4 lbs without feeling pain, even if my arm is supported.
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My affected arm moves without me trying to move it.
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I have a dislocated or painful shoulder.
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I have a skin rash or open wound on my arm.
Select...
I have had seizures in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline arm function after 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline arm function after 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in arm impairment using Fugl-Meyer assessment (FMA)
Secondary study objectives
Changes in arm function using Action Research Arm Test (ARAT)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FeasibilityExperimental Treatment1 Intervention
To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,856 Total Patients Enrolled
86 Trials studying Stroke
6,870 Patients Enrolled for Stroke
Ahlam Salameh, PhD MScPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

Media Library

MARK Clinical Trial Eligibility Overview. Trial Name: NCT04599036 — N/A
Stroke Research Study Groups: Feasibility
Stroke Clinical Trial 2023: MARK Highlights & Side Effects. Trial Name: NCT04599036 — N/A
MARK 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599036 — N/A
~3 spots leftby Sep 2026
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