MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury

February 6, 2024 updated by: Joel Stein, MD, Columbia University

MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Joel Stein, MD
  • Phone Number: 212-305-4818

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyHand-SCI Device Testing
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
Device: Testing of MyHand-SCI Device
Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: Up to 2 years at study completion
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).
Up to 2 years at study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Joel Stein, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU2339
  • R01NS115652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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