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EMG-Controlled Game Therapy for Stroke (GAM Trial)
N/A
Recruiting
Led By Na Jin Seo, PhD MS BS
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
18+ years old
Moderate upper limb impairment
Must not have
Severe spasticity prohibiting voluntary muscle contraction to participate in training
Comorbidity (e.g., orthopaedic or premorbid neurologic condition) that limit upper limb movement and/or participation in the intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week from intervention completion
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if specially tailored physical therapy can improve upper limb function in stroke survivors over 2.5 months.
Who is the study for?
This trial is for stroke survivors over 18 years old with moderate upper limb impairment, who can see a computer screen and have the cognitive ability to follow study procedures. It's not suitable for those with severe language or cognitive barriers, total sensory loss in the limbs, ongoing arm rehab, extreme muscle stiffness preventing movement, recent spasticity treatment changes, or other conditions affecting arm use.
What is being tested?
The study tests whether practicing muscle activation patterns and task practice can improve arm function after a stroke. Participants will visit the lab three times weekly for six weeks to engage in these activities and will also attend three additional visits for assessments of their arm function over about 2.5 months.
What are the potential side effects?
Since this intervention involves physical therapy exercises rather than medication, typical side effects associated with drugs are not expected. However, participants may experience fatigue or discomfort from the exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have moderate difficulty using my arms.
Select...
I can see the full computer screen clearly.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My severe muscle stiffness prevents me from moving my muscles voluntarily.
Select...
I have a health condition that limits my arm movement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 week from intervention completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 week from intervention completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Wolf Motor Function Test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EMG + task trainingExperimental Treatment2 Interventions
Train with EMG-controlled games and functional task practice
Group II: task trainingActive Control1 Intervention
Train with functional task practice
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,747 Total Patients Enrolled
86 Trials studying Stroke
6,818 Patients Enrolled for Stroke
Na Jin Seo, PhD MS BSPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
2 Previous Clinical Trials
51 Total Patients Enrolled
2 Trials studying Stroke
51 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am currently undergoing rehabilitation for my upper limb.I had a stroke over 6 months ago.I haven't changed my spasticity medication or had a botulinum toxin injection in my arm in the last 3 months.My severe muscle stiffness prevents me from moving my muscles voluntarily.I have moderate difficulty using my arms.I have a health condition that limits my arm movement.You have complete loss of sensation.I am mentally capable of following the study's procedures.I can see the full computer screen clearly.
Research Study Groups:
This trial has the following groups:- Group 1: EMG + task training
- Group 2: task training
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.