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Locomotion and Global Positioning System in Arterial Disease

Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00485147
Acronym
Starter-GPS
Enrollment
140
Registered
2007-06-12
Start date
2006-03-31
Completion date
2010-12-31
Last updated
2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Claudication, peripheral arterial disease, Diagnosis, Exercise, Walking impairment, Disability

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.

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.

Interventions

PROCEDURERecording 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.

Sponsors

Société Française de Médecine Vasculaire
CollaboratorUNKNOWN
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 measurements4 years
Determine the variability of the walking capacity and its potential determinants in PAD patients.3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026