Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416345
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-07
Brief Title:
Cue2Walk Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinsons Disease
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Cue2Walk Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 majority of people with Parkinsons disease incur Freezing of Gait FoG which is not addressed adequately by medication Cueing is a proven strategy to overcome FoG The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues In this study the cost-effectiveness of the Cue2Walk device as compared to usual care is investigated
Detailed Description:
Freezing of gait FoG is one of the most common and disabling motor symptoms of Parkinsons disease and is associated with poorer quality of life However current pharmacological or even surgical treatments do not address FoG adequately and innovative rehabilitation strategies are needed Cueing is a proven strategy to overcome FoG episodes and an essential part in the management of FoG The Cue2Walk a Medical Device Class I CE-certified leg-worn device addresses the debilitating effects of FoG episodes at home with smart cueing by combining automatic detection of a freezing episode with manual or automatic rhythmic cues auditory or vibro-tactile This study aims to investigate the cost-effectiveness of the Cue2Walk device as compared to usual care This study is a multicenter randomized clinical trial with 2 parallel groups 24-week intervention group and 24-week waiting list group After 24 weeks an 8-week naturalistic follow-up will be implemented for the intervention group while participants in the waiting list group will also receive the intervention but for 8 weeks Frequently repeated assessment of outcomes measures will be conducted
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