MyHand 2: An Active Hand Orthosis for Stroke Patients

NCT04436042 | Recruiting FDA Device

• 2 other identifiers: AAAS8104R01NS115652
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Hemiparesis

Keywords

Stroke; Rehabilitation; Hemiparesis; Robotics

Outcome Measures

Primary Outcomes (1)

• Device Usability and Utility Questionnaire Score

  Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree. The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility.

  Up to 1 year at study completion

Study Arms (1)

MyHand Treatment

EXPERIMENTAL

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

Device: MyHand Device

Interventions

MyHand Device DEVICE

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

MyHand Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other neurological conditions besides stroke
• Other orthopedic conditions to affected upper extremity
• Significant spasticity in affected upper extremity that impairs device fit

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carley Teachout, MS

CONTACT

212-305-6722; ct3351@cumc.columbia.edu

Joel Stein, MD

CONTACT

212-305-4818

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of the Department of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: March 6, 2020
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)