Locomotion and Global Positioning System in Arterial Disease
Starter-GPS
Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 11, 2007
CompletedFirst Posted
Study publicly available on registry
June 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 2, 2012
April 1, 2010
4.8 years
June 11, 2007
June 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.
2 years
Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.
2 years
Secondary Outcomes (3)
Determine the variability of the walking capacity and its potential determinants in PAD patients.
3 years
Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.
4 years
Analyse potential factors that could affect the accuracy of GPS measurements
4 years
Interventions
Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.
Eligibility Criteria
You may qualify if:
- Ankle to Brachial Index (ABI) \< 0.95 for PAD patients
- Age \> 18 years old
- Able to walk on treadmill
You may not qualify if:
- limb pain of potential non-vascular origin
- myocardial infraction in the last six months
- uncontrolled angina pectoris
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier universitaire
Angers, 49933, France
Related Publications (2)
Noury-Desvaux B, Abraham P, Mahe G, Sauvaget T, Leftheriotis G, Le Faucheur A. The accuracy of a simple, low-cost GPS data logger/receiver to study outdoor human walking in view of health and clinical studies. PLoS One. 2011;6(9):e23027. doi: 10.1371/journal.pone.0023027. Epub 2011 Sep 13.
PMID: 21931593DERIVEDLe Faucheur A, Noury-Desvaux B, Mahe G, Sauvaget T, Saumet JL, Leftheriotis G, Abraham P. Variability and short-term determinants of walking capacity in patients with intermittent claudication. J Vasc Surg. 2010 Apr;51(4):886-92. doi: 10.1016/j.jvs.2009.10.120.
PMID: 20347684DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pierre Abraham, MD, PhD
Laboratory for Vascular Investigations. University Hospital. Angers. France.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2007
First Posted
June 12, 2007
Study Start
March 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 2, 2012
Record last verified: 2010-04