MyHand 2: An Active Hand Orthosis for Stroke Patients

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04436042
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
25
1
1
63.8
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MyHand Device
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
MyHand 2: An Active Hand Orthosis for Stroke Patients
Actual Study Start Date :
Mar 6, 2020
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MyHand Treatment

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

Device: MyHand Device
These subjects may be asked to attend 1-10 sessions (approximately 90 mins) to trial a variety of device controls and/or components.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Other neurological conditions besides stroke

  • Other orthopedic conditions to affected upper extremity

  • Significant spasticity in affected upper extremity that impairs device fit

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Irving Medical Center New York New York United States 10032

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Joel Stein, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joel Stein, MD, Professor and Chair of the Department of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier:
NCT04436042
Other Study ID Numbers:
  • AAAS8104
  • R01NS115652
First Posted:
Jun 17, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Joel Stein, MD, Professor and Chair of the Department of Rehabilitation and Regenerative Medicine, Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022