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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
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
 Procedure: Recording of GPS during a free walking in a public park

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 140
Study Start Date: March 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485147

Locations
France
Centre hospitalier universitaire
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Société Française de Médecine Vasculaire
Investigators
Study Director: Pierre Abraham, MD, PhD Laboratory for Vascular Investigations. University Hospital. Angers. France.
  More Information

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00485147     History of Changes
Other Study ID Numbers: CP 2005-04
Study First Received: June 11, 2007
Last Updated: June 28, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
Claudication
peripheral arterial disease
Diagnosis
 Exercise
Walking impairment
Disability

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
 Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015