Back to resultsMyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Tetraplegia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing of MyHand-SCI Device
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Tetraplegia, Rehabilitation, Robotics, Assistive Technology, Wearable Devices
Eligibility Criteria
Inclusion Criteria:
- Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function
- Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function
- Able to provide informed consent
Exclusion Criteria:
- Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device
- Severe spasticity (modified Ashworth >2) at elbow, wrist, or fingers
- Any open wounds or unusual skin fragility
- Persistent severe pain in their upper limb
Sites / Locations
- Columbia University Irving Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MyHand-SCI Device Testing
Arm Description
Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device
Outcomes
Primary Outcome Measures
System Usability Scale
The System Usability Scale (SUS) is a reliable tool for measuring the usability of products, including medical devices. It consists of a 10 item questionnaire with five response options (Strongly agree to Strongly disagree).
Secondary Outcome Measures
Full Information
NCT ID
NCT05553457
First Posted
September 21, 2022
Last Updated
November 9, 2022
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT05553457
Brief Title
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Official Title
MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury.
Detailed Description
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury. This is a non-randomized exploratory study to determine feasibility of device use, provide user feedback on device features and function to allow further refinement of the device, and assess the utility and responsiveness of several clinical outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Tetraplegia
Keywords
Spinal Cord Injuries, Tetraplegia, Rehabilitation, Robotics, Assistive Technology, Wearable Devices
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MyHand-SCI Device Testing
Arm Type
Experimental
Arm Description
Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device
Intervention Type
Device
Intervention Name(s)
Testing of MyHand-SCI Device
Intervention Description
Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.
Primary Outcome Measure Information:
Title
System Usability Scale
Description
The System Usability Scale (SUS) is a reliable tool for measuring the usability of products, including medical devices. It consists of a 10 item questionnaire with five response options (Strongly agree to Strongly disagree).
Time Frame
Up to 2 years at study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function
Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function
Able to provide informed consent
Exclusion Criteria:
Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device
Severe spasticity (modified Ashworth >2) at elbow, wrist, or fingers
Any open wounds or unusual skin fragility
Persistent severe pain in their upper limb
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, MD
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
Learn more about this trial
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
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