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RecruitingNCT04436042MyHand 2Updated Apr 13, 2026

MyHand 2: An Active Hand Orthosis for Stroke Patients

An interventional study of MyHand Device in Stroke and Hemiparesis, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Columbia University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke
  • Hemiparesis

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Keywords

  • Stroke
  • Rehabilitation
  • Hemiparesis
  • Robotics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Other neurological conditions besides stroke
  • Other orthopedic conditions to affected upper extremity
  • Significant spasticity in affected upper extremity that impairs device fit
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    MyHand Treatment

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

    Device: MyHand Device

Interventions

  • DeviceMyHand Device

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

05

What researchers measure

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.

    Time frame: Up to 1 year at study completion

06

Study locations

1 of 1 sites recruiting
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04436042
Lead sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Joel Stein, MD (Professor and Chair of the Department of Rehabilitation and Regenerative Medicine, Columbia University) — Principal investigator
First posted
Jun 17, 2020
Start date
Mar 6, 2020
Primary completion
Jan 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Apr 13, 2026

Study contacts

Carley Teachout, MS
Contact
ct3351@cumc.columbia.edu
212-305-6722
Joel Stein, MD
Contact
212-305-4818
Joel Stein, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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