Locomotion and Global Positioning System in Arterial Disease

Peripheral Arterial Disease Clinical Trial

— Starter-GPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485147
• Other study ID #: CP 2005-04
• Status: Completed
• Phase: N/A
• First received: June 11, 2007
• Last updated: June 28, 2012
• Start date: March 2006
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Société Française de Médecine Vasculaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.		2 years	No
Primary	Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.		2 years	No
Secondary	Determine the variability of the walking capacity and its potential determinants in PAD patients.		3 years	No
Secondary	Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.		4 years	No
Secondary	Analyse potential factors that could affect the accuracy of GPS measurements		4 years	No