Locomotion and Global Positioning System in Arterial Disease (Starter-GPS)
|ClinicalTrials.gov Identifier: NCT00485147|
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : July 2, 2012
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Procedure: Recording of GPS during a free walking in a public park|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease|
|Study Start Date :||March 2006|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Procedure: Recording of GPS during a free walking in a public park
- Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects. [ Time Frame: 2 years ]
- Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients. [ Time Frame: 2 years ]
- Determine the variability of the walking capacity and its potential determinants in PAD patients. [ Time Frame: 3 years ]
- Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients. [ Time Frame: 4 years ]
- Analyse potential factors that could affect the accuracy of GPS measurements [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485147
|Centre hospitalier universitaire|
|Angers, France, 49933|
|Study Director:||Pierre Abraham, MD, PhD||Laboratory for Vascular Investigations. University Hospital. Angers. France.|