Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 11:45 PM
Study NCT ID:
NCT05553457
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2022-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injury
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
MyHand-SCI: a Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01NS115652 | NIH | None | https://reporter.nih.gov/quic… | View |