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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 belowSelect...
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:Select...
My family has a history of epilepsy that doesn't respond well to medication.
Select...
I have had a stroke that affected my ability to move the opposite side of my body.
Select...
I can't lift my arm sideways or in front above shoulder level.
Select...
I have stiff joints in my arm and hand that I cannot fully straighten.
Select...
I have had a bleeding stroke.
Select...
I am taking medication that could increase my risk of seizures.
Select...
I have long-term sleep problems that haven't been treated.
Select...
I cannot hold my arm up with an extra 4 lbs without feeling pain, even if my arm is supported.
Select...
My affected arm moves without me trying to move it.
Select...
I have a dislocated or painful shoulder.
Select...
I have a skin rash or open wound on my arm.
Select...
I have had seizures in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline arm function after 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline arm function after 6 weeks
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
1,664 Previous Clinical Trials
3,765,773 Total Patients Enrolled
86 Trials studying Stroke
6,873 Patients Enrolled for Stroke
Ahlam Salameh, PhD MScPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My family has a history of epilepsy that doesn't respond well to medication.I have had a stroke that affected my ability to move the opposite side of my body.I can't lift my arm sideways or in front above shoulder level.I had a stroke caused by a clot between 2 days and 6 months ago.You have a low score on specific tests that measure finger and shoulder movement.You have metal in your skull.I have stiff joints in my arm and hand that I cannot fully straighten.You can consistently and intentionally produce detectable muscle signals in your upper and lower arm with your wrist in a normal or bent position, as detected by the Myopro software.I have had a bleeding stroke.I am taking medication that could increase my risk of seizures.I can move my elbow, forearm, wrist, and hand well enough to wear a device.I have long-term sleep problems that haven't been treated.I cannot hold my arm up with an extra 4 lbs without feeling pain, even if my arm is supported.You feel very uncomfortable in small spaces, or you can't use the button to call for help during an MRI.I can follow instructions.My affected arm moves without me trying to move it.I am a veteran and over 18 years old.I have a dislocated or painful shoulder.Your arm muscles have a high score for stiffness and tightness.You have a pacemaker or other implanted devices.I have a skin rash or open wound on my arm.I have had seizures in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Feasibility
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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