Peripheral Arterial Disease Clinical Trial
Official title:
Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
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.
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
WAAS/EGNOS 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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