MyHand 2: An Active Hand Orthosis for Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke; Hemiparesis
• Interventions: Device: MyHand Device

• Registration Number: NCT04436042
• Lead Sponsor: Columbia University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MyHand Treatment	MyHand Device	Participants will use the MyHand device during repetitive grasp and release tasks.

Primary Outcome Measures

Name	Time	Method
Device Usability and Utility Questionnaire Score	Up to 1 year at study completion	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York City, New York, United States