MyHand 2: An Active Hand Orthosis for Stroke Patients

Stroke Clinical Trial

— MyHand 2  

Official title:

MyHand 2: An Active Hand Orthosis for Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436042
• Other study ID #: AAAS8104
• Secondary ID: R01NS115652
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Lauren Winterbottom, MS
• Phone: 212-305-6722
• Email: lbw2136[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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