Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483230
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
Implementation of IVS3 for Upper Limb Motor Recovery
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Pilot Study on Tolerance and Ease of Implementation of Intensive Visual Stimulation IVS3 in Daily Practice for Upper Limb Motor Recovery in Outpatient Rehab Center
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting
Detailed Description:
This study will investigate the implementation of the intensive visual stimulation three IVS3 device in the outpatient rehabilitation setting This is a phase III open label study that will assess participant satisfaction and upper extremity function in outpatients with chronic stroke 10 with hemi spatial neglect and 15 without when exposed to IVS3 for 30 minutes and conventional treatment for 15 minutes across 12 sessions in 4-6 weeks at Weill Cornell medicine outpatient rehabilitation single site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None