Locomotion and Global Positioning System in Arterial Disease (Starter-GPS)
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|ClinicalTrials.gov Identifier: NCT00485147|
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : July 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Procedure: Recording of GPS during a free walking in a public park||Not Applicable|
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|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- Procedure: Recording of GPS during a free walking in a public park
Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|