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MyHand Device for Stroke-Related Hand Impairment (MyHand 2 Trial)
N/A
Recruiting
Led By Joel Stein
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intact cognition to follow directions
Upper extremity weakness with impaired ability to complete daily activities with affected hand
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year at study completion
Awards & highlights
MyHand 2 Trial Summary
This trial is to test and improve a device called MyHand, which helps people with reduced hand function after a stroke.
Who is the study for?
This trial is for adults over 18 who had a stroke at least six months ago and now have weakness in one hand, making daily tasks hard. They must be able to move their fingers fully, follow directions well, and control the upper part of the affected arm. People with other brain or nerve conditions or other issues with that arm can't join.Check my eligibility
What is being tested?
The MyHand device is being tested to see if it helps improve hand function in stroke patients. The study involves refining this assistive technology based on feedback from earlier tests to make it more effective and user-friendly.See study design
What are the potential side effects?
Since this trial involves a non-invasive device designed to aid hand movement post-stroke, side effects may include discomfort while using the device or fatigue due to therapy exercises but are generally expected to be minimal.
MyHand 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and follow instructions.
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I have weakness in my arm or hand that makes daily tasks hard.
Select...
I can fully extend and bend all my fingers.
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I can control the muscles in my upper arm and shoulder.
MyHand 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year at study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year at study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Usability and Utility Questionnaire Score
MyHand 2 Trial Design
1Treatment groups
Experimental Treatment
Group I: MyHand TreatmentExperimental Treatment1 Intervention
Participants will use the MyHand device during repetitive grasp and release tasks.
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,336 Total Patients Enrolled
171 Trials studying Stroke
83,833 Patients Enrolled for Stroke
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,460,990 Total Patients Enrolled
36 Trials studying Stroke
25,838 Patients Enrolled for Stroke
Joel Stein3.69 ReviewsPrincipal Investigator - Columbia University
Columbia University
5Patient Review
I visited as part of a cardiac rehabilitation program. Dr. Stein and his assistant/secretary Kathleen were very kind and hospitable. It was easy to schedule an appointment, and Dr. Stein took his time examining me. The visit went smoothly overall.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I have a neurological condition other than stroke.I can understand and follow instructions.My last stroke was more than six months ago.I have weakness in my arm or hand that makes daily tasks hard.I have other bone or joint issues in my arm.I can fully extend and bend all my fingers.I can control the muscles in my upper arm and shoulder.I have severe muscle stiffness in my arm that affects how devices fit.
Research Study Groups:
This trial has the following groups:- Group 1: MyHand Treatment
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.
How many subjects are participating in this clinical trial?
"Affirmative. Clinicaltrials.gov highlights the fact that this research is currently recruiting subjects, with its inception on March 6th 2020 and most recent update from March 7th 2022. 25 participants are being enrolled at a single location for this trial."
Answered by AI
Are there any openings currently available for this investigation?
"Affirmative. The clinical trial details uploaded to clinicaltrials.gov signify that the study is actively signing up volunteers, which were first posted on March 6th 2020 and most recently updated on March 7th 2022. 25 participants are expected from 1 medical site."
Answered by AI
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