Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485147
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2007-06-11
Brief Title:
Locomotion and Global Positioning System in Arterial Disease
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Study of Human Locomotion With Global Positioning System Application to Patients With Peripheral Arterial Disease
Status:
COMPLETED
Status Verified Date:
2010-04
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:
Starter-GPS
Brief Summary:
The maximal walking distance MWD performed on treadmill TT remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease PAD with intermittent claudication although treadmills are not accessible to most physicians We hypothesized that global positioning system GPS recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients
Detailed Description:
The study has two main objectives conducted together Each objective include several phases
Objective 1 technical validation of GPS measurements in healthy subjects
phase 1 technical validation of a GPS device to study outdoor walking completed
phase 2 comparison and use of various GPS devices intra- and inter-GPS variability in the study outdoor walking on-going
phase 3 study of several factors that could influence accuracy of GPS measurements as walking speed environment sampling frequency and others technical features as the WAASEGNOS function on-going
Objective 2 Application in PAD patients to study walking capacity under free-living conditions
phase 1 comparison of GPS measurements maximal walking distance with the gold standard treadmill measurement of maximal walking distance completed
phase 2 analysis of the variability of the walking capacity under free-living conditions from GPS measurements completed
phase 3 study of reliability and sensibility effect of treatment of GPS measurements on-going
phase 4 study of the relationship between laboratory measurements of walking capacity and GPS-derived parameters
Objective 1 technical validation of GPS measurements in healthy subjects
phase 1 technical validation of a GPS device to study outdoor walking completed
phase 2 comparison and use of various GPS devices intra- and inter-GPS variability in the study outdoor walking on-going
phase 3 study of several factors that could influence accuracy of GPS measurements as walking speed environment sampling frequency and others technical features as the WAASEGNOS function on-going
Objective 2 Application in PAD patients to study walking capacity under free-living conditions
phase 1 comparison of GPS measurements maximal walking distance with the gold standard treadmill measurement of maximal walking distance completed
phase 2 analysis of the variability of the walking capacity under free-living conditions from GPS measurements completed
phase 3 study of reliability and sensibility effect of treatment of GPS measurements on-going
phase 4 study of the relationship between laboratory measurements of walking capacity and GPS-derived parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None