Locomotion and Global Positioning System in Arterial Disease (Starter-GPS)

This study has been completed.
Sponsor:
Collaborator:
Société Française de Médecine Vasculaire
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00485147
First received: June 11, 2007
Last updated: June 28, 2012
Last verified: April 2010

June 11, 2007
June 28, 2012
March 2006
December 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Validate the ability of GPS to detect walking and resting bouts in normal and diseased aptients [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00485147 on ClinicalTrials.gov Archive Site
  • Determine the variability of the walking capacity and its potential determinants in PAD patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Analyse potential factors that could affect the accuracy of GPS measurements [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Compare maximal walking distance from GPS from distance with treadmill [ Time Frame: 2 years ]
  • Analyse the walking variability of patients with PAD [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Locomotion and Global Positioning System in Arterial Disease
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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Peripheral Arterial Disease
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ankle to Brachial Index (ABI) < 0.95 for PAD patients
  • Age > 18 years old
  • Able to walk on treadmill

Exclusion Criteria:

  • limb pain of potential non-vascular origin
  • myocardial infraction in the last six months
  • uncontrolled angina pectoris
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00485147
CP 2005-04
No
University Hospital, Angers
University Hospital, Angers
Société Française de Médecine Vasculaire
Study Director: Pierre Abraham, MD, PhD Laboratory for Vascular Investigations. University Hospital. Angers. France.
University Hospital, Angers
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP