Claudication, Systematic Evaluation of Limp on Treadmill

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: Biomechanic parameters

• Registration Number: NCT02754804
• Lead Sponsor: University Hospital, Angers

Brief Summary

Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication

Detailed Description

Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.

Study Timeline

• Study First Submitted: 2016-04-16
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Study Start: 2016-07
• Primary Completion: 2017-06
• Study Completion: 2020-03-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Referred for treadmill testing
• Age > 18
• Claudication
• Covered by the French Healthcare system
• Consent to participate

Exclusion Criteria

• Unstable angina
• History of lower limb osteo articular rheumatologic disease
• Lower limb amputation
• Cardiac or respiratory failure
• Neurologic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAD patients	Biomechanic parameters	Patients with grade 1 claudication Measurement of biomechanic parameters while walking on treadmill

Primary Outcome Measures

Name	Time	Method
Root mean square (RMS) of the electromyogram signal	Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients)	Calculation for the difference (change) in RMS value at the end vs.beginning of the walking test (RMS is calculated over 15 sec at rest and 15 sec just before the end of the walking period)

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Angers, France