Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385392
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-22
Brief Title:
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait
Status:
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:
The proposed system haptic module and insole device for daily in-community use that detects the occurrence of freezing of gait FOG in people with Parkinsons disease PD and triggers external cueing stimuli to unfreeze the individual The purpose of the overall Phase II study is to 1 Develop a production ready system 2 Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms and 3 Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing This study will focus on validating the system and demonstrating efficacy through in-community testing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None