Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:42 PM
Study NCT ID:
NCT07458568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ViBandz Feasibility Study
Sponsor:
Children's Mercy Hospital Kansas City
Organization:
Study Overview
Official Title:
ViBandz Feasibility Study in the Neurological Pediatric Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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 is a single site, mixed methods, feasibility study of the ViBandz device at a Midwest pediatric tertiary care hospital in a physical and occupational therapy clinic.
Detailed Description:
This proposal is for a single-site, feasibility study of the use of ViBandz in a treatment population. The analysis is a mixed methods approach with quantitative feedback on surveys and a secondary qualitative review of audio/+/- video that was obtained during the device use. The survey will be done immediately after the study on a device in clinic by the parents. If parents do not have time to finish it then, an email will be sent. Video and audio during the visit will provide additional rich data to understand the device beyond what a standard quantitative survey could provide. Subjects will have their standard clinical care- targeted vibration and then after their visit is completed, they will complete the use of the ViBandz This order will occur with all participants.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: