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Claudication, Systematic Evaluation of Limp on Treadmill

Claudication et Fatigue Musculaire de l'artériopathe

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02754804
Acronym
CLAUSEL
Enrollment
190
Registered
2016-04-28
Start date
2016-07-31
Completion date
2020-03-12
Last updated
2020-08-14

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

Conditions

Peripheral Artery Disease

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.

Interventions

DEVICEBiomechanic parameters

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

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Root mean square (RMS) of the electromyogram signalEvaluation 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026