Claudication, Systematic Evaluation of Limp on Treadmill

NCT02754804 | Completed

• 1 other identifier: 2016-A000052-49
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

PAD patients

Patients with grade 1 claudication Measurement of biomechanic parameters while walking on treadmill

Device: Biomechanic parameters

Interventions

Biomechanic parameters DEVICE

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

PAD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients complaining claudication and referred for a treadmill test

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• pierre Abraham, MD PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2016
• First Posted: April 28, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: March 12, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)