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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
Must not have
Other neurological conditions besides stroke
Other orthopedic conditions to affected upper extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year at study completion
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and follow instructions.
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I have weakness in my arm or hand that makes daily tasks hard.
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I can fully extend and bend all my fingers.
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I can control the muscles in my upper arm and shoulder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a neurological condition other than stroke.
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I have other bone or joint issues in my arm.
Select...
I have severe muscle stiffness in my arm that affects how devices fit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year at study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year at study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device Usability and Utility Questionnaire Score

Trial Design

1Treatment groups
Experimental Treatment
Group I: MyHand TreatmentExperimental Treatment1 Intervention
Participants will use the MyHand device during repetitive grasp and release tasks.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,362 Previous Clinical Trials
650,725 Total Patients Enrolled
173 Trials studying Stroke
81,145 Patients Enrolled for Stroke
Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,325 Total Patients Enrolled
37 Trials studying Stroke
23,054 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.

Media Library

MyHand Device (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04436042 — N/A
Stroke Research Study Groups: MyHand Treatment
Stroke Clinical Trial 2023: MyHand Device Highlights & Side Effects. Trial Name: NCT04436042 — N/A
MyHand Device (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04436042 — N/A
~2 spots leftby Mar 2025
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