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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

No Placebo-Only Group

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:

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I have a neurological condition other than stroke.

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I have other bone or joint issues in my arm.

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I have severe muscle stiffness in my arm that affects how devices fit.

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

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

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: MyHand TreatmentExperimental Treatment1 Intervention

Participants will use the MyHand device during repetitive grasp and release tasks.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,378 Previous Clinical Trials

652,167 Total Patients Enrolled

179 Trials studying Stroke

81,466 Patients Enrolled for Stroke

Columbia UniversityLead Sponsor

1,486 Previous Clinical Trials

2,663,165 Total Patients Enrolled

37 Trials studying Stroke

23,026 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.