Spinal Cord InjuriesNCT05553457
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
A study testing Testing of MyHand-SCI Device in people with Spinal Cord Injuries and Tetraplegia, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Tetraplegia
- What is being tested?
- Testing of MyHand-SCI Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joel Stein, MD contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Carley Teachout, MS, 212-305-6722, ct3351@cumc.columbia.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Being tested
- Testing of MyHand-SCI Device
- Keywords
- Spinal Cord Injuries, Tetraplegia, Rehabilitation, Robotics, Assistive Technology, Wearable Devices
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of MyHand-SCI DeviceDevice
Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.
| Study group | Role | What they receive |
|---|---|---|
| MyHand-SCI Device Testing | Experimental | 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 Receives: Device: Testing of MyHand-SCI Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2 years at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start4 Oct 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Stein, MD, Columbia University
- Investigators
- Joel Stein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553457
- Sponsor's protocol ID
- AAAU2339
- Other IDs
- R01NS115652
- Status last verified
- Nov 2026
- First submitted
- 21 Sep 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05553457
- Acronym / sponsor ID
- AAAU2339
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Keywords
- Spinal Cord Injuries, Tetraplegia, Rehabilitation, Robotics, Assistive Technology, Wearable Devices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyHand-SCI Device Testing | Experimental | Device: Testing of MyHand-SCI DeviceSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing of MyHand-SCI DeviceSubjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components. | Device | MyHand-SCI Device Testing |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Stein, MD contact
Joel Stein, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing of MyHand-SCI Device in people with Spinal Cord Injuries and Tetraplegia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carley Teachout, MS (212-305-6722, ct3351@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Up to 2 years at study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.