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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05553457

Enrollment

Registered

2022-09-23

Start date

2022-10-04

Completion date

2027-09-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries, Tetraplegia

Keywords

Spinal Cord Injuries, Tetraplegia, Rehabilitation, Robotics, Assistive Technology, Wearable Devices

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.

Interventions

DEVICETesting 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
System Usability Scale	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).

Countries

United States

Contacts

CONTACTLauren Winterbottom, EdD

lbw2136@cumc.columbia.edu212-305-6722

CONTACTJoel Stein, MD

212-305-4818

PRINCIPAL_INVESTIGATORJoel Stein, MD

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026