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MyHand 2: An Active Hand Orthosis for Stroke Patients (MyHand 2)

Primary Purpose

Stroke, Hemiparesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyHand Device
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, Rehabilitation, Hemiparesis, Robotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MyHand Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2020
Last Updated
May 8, 2023
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT04436042
Brief Title
MyHand 2: An Active Hand Orthosis for Stroke Patients
Acronym
MyHand 2
Official Title
MyHand 2: An Active Hand Orthosis for Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Stroke, Rehabilitation, Hemiparesis, Robotics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyHand Treatment
Arm Type
Experimental
Arm Description
Participants will use the MyHand device during repetitive grasp and release tasks.
Intervention Type
Device
Intervention Name(s)
MyHand Device
Intervention Description
These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
Primary Outcome Measure Information:
Title
Device Usability and Utility Questionnaire Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Winterbottom, MS
Phone
212-305-6722
Email
lbw2136@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Stein, MD
Phone
212-305-4818
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Stein
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Winterbottom, MS
Phone
212-305-6722
Email
lbw2136@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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MyHand 2: An Active Hand Orthosis for Stroke Patients

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