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Myoelectric Orthosis
Myoelectric Orthosis for Stroke Recovery
N/A
Waitlist Available
Research Sponsored by Myomo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
Minimum of trace MMT (1/5) in Biceps and/or Triceps
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
Study Summary
This trial looks at whether or not a myoelectric Elbow-Wrist-Hand orthosis, which is a device that helps people with upper limb paralysis caused by a stroke, improves function.
Who is the study for?
This trial is for adults over 18 who've had a stroke leading to upper limb paralysis. They must have some shoulder movement, be able to understand English, and produce detectable muscle signals in their upper arm. People with severe shoulder issues, pain or hypersensitivity in the arms, fixed contractures, high spasticity or tone, or those unable to follow simple instructions cannot participate.Check my eligibility
What is being tested?
The study is testing a myoelectric Elbow-Wrist-Hand orthosis device designed to help people with arm paralysis from strokes regain function. Participants will use this advanced brace that responds to muscle signals to see if it improves their ability to move and use their affected arm.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort from wearing the device, skin irritation at sensor sites, fatigue from therapy sessions using the orthosis and possible frustration if desired improvements are not achieved.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can lift my arm sideways and upwards at least a little.
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I have some muscle strength in my arms.
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I have arm or hand problems due to a stroke.
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I can fully move my elbow, forearm, wrist, and hand without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Box and Blocks Test
Upper Extremity
Modified Ashworth Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Myoelectric Elbow-Wrist-Hand OrthosisExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
MyomoLead Sponsor
4 Previous Clinical Trials
125 Total Patients Enrolled
4 Trials studying Stroke
125 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience pain or unusual sensitivity in my arm(s).I can lift my arm sideways and upwards at least a little.I have severe muscle stiffness or spasticity.I have severe shoulder pain or my shoulder easily comes out of place.I have a stiff arm that cannot fully move.I have some muscle strength in my arms.You need to be able to consistently produce a detectable EMG signal from sensors placed on your upper arm and forearm, with your wrist in a neutral or flexed position.I am over 18 years old.I can't lift my arm sideways or in front of me higher than a low angle.I cannot follow three-step instructions.I have arm or hand problems due to a stroke.You need to score at least 20 on a memory and thinking test called the Mini Mental Status Examination.I can fully move my elbow, forearm, wrist, and hand without help.
Research Study Groups:
This trial has the following groups:- Group 1: Myoelectric Elbow-Wrist-Hand Orthosis
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for new participants in this research study?
"Clinicaltrials.gov reveals that this scientific examination is not presently accepting participants, despite being published on July 1st 2015 and last updated September 4th of the same year. However, there are still 1046 additional trials actively recruiting patients at present."
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