Claudication, Systematic Evaluation of Limp on Treadmill

Peripheral Artery Disease Clinical Trial

— CLAUSEL  

Official title:

Claudication et Fatigue Musculaire de l'artériopathe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754804
• Other study ID #: 2016-A000052-49
• Status: Completed
• Start date: July 2016
• Est. completion date: March 12, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 12, 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Biomechanic parameters
recording of biomechanic parameters and surface electromyography at the thigh and calf level throughout the walking period, in PAD patients .

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root mean square (RMS) of the electromyogram signal	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)	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)