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NCT Number: NCT05553457

MyHand-SCI: An Active Hand Orthosis for 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.

Recruiting

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Lauren Winterbottom, EdD

CONTACT

[email protected]

212-305-6722

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testing of MyHand-SCI Device

Device

Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.

Primary outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Stein, MD

CONTACT

212-305-4818

Lauren Winterbottom, EdD

CONTACT

[email protected]

212-305-6722

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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