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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05553457
Recruitment Status : Recruiting
First Posted : September 23, 2022
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Joel Stein, MD, Columbia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tetraplegia Device: Testing of MyHand-SCI Device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
Actual Study Start Date : October 4, 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553457


Contacts
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Contact: Lauren Winterbottom, MS 212-305-6722 lbw2136@cumc.columbia.edu
Contact: Joel Stein, MD 212-305-4818

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lauren Winterbottom, MS    212-305-6722    lbw2136@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Joel Stein, MD Columbia University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Joel Stein, MD, Professor and Chair of the Department of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT05553457    
Other Study ID Numbers: AAAU2339
R01NS115652 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Joel Stein, MD, Columbia University:
Spinal Cord Injuries
Tetraplegia
Rehabilitation
 Robotics
Assistive Technology
Wearable Devices
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations