MyHand 2: An Active Hand Orthosis for Stroke Patients

NCT ID: NCT04436042

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2028-01-31

Brief Summary

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This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.

Detailed Description

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From previous experimentation with the MyHand device, the investigators have determined that the device can improve the grasping ability of stroke patients. The investigators now aim to make the controls more intuitive and accurate for the users, to enable subjects to grasp a wider array of objects, to make the donning and doffing of the device easier, and to continue to assess the MyHand as it helps subjects in functional tasks.

Conditions

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Stroke Hemiparesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MyHand Treatment

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

Group Type EXPERIMENTAL

MyHand Device

Intervention Type DEVICE

These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.

Interventions

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MyHand Device

These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years old
* History of stroke(s) with most recent stroke at least six months ago
* Upper extremity weakness with impaired ability to complete daily activities with affected hand
* Full passive range of motion in all digits
* Intact cognition to follow directions
* Gross control of proximal upper extremity musculature

Exclusion Criteria

* Other neurological conditions besides stroke
* Other orthopedic conditions to affected upper extremity
* Significant spasticity in affected upper extremity that impairs device fit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Joel Stein, MD

Professor and Chair of the Department of Rehabilitation and Regenerative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel Stein

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Winterbottom, MS

Role: CONTACT

212-305-6722

Joel Stein, MD

Role: CONTACT

212-305-4818

Facility Contacts

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Lauren Winterbottom, MS

Role: primary

212-305-6722

Other Identifiers

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R01NS115652

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS8104

Identifier Type: -

Identifier Source: org_study_id

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