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Clinical Trial Summary

This is an observational, prospective multicentric study designed to develop medical knowledge. The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb amputee patients. The questionnaire is administered twice to each patient, once during the consultation and again when they return home. Patients also undergo a 6-minute walk test.


Clinical Trial Description

This is an observational, prospective multicentric study designed to develop medical knowledge. The IPAQ is an internationally validated questionnaire for measuring physical activity in healthy subjects. The IPAQ-SF (short format of the IPAQ) assesses overall physical activity and sedentary time during the last seven days. The IPAQ-SF has been used in a population of lower limb amputees on several occasions, but no study of its psychometric qualities in application to this population has been performed to date. The main objective of the study is therefore to gather a set of arguments allowing the IPAQ-SF to be used in the follow-up consultation of patients with lower limb amputations who are fitted with a device. This would help health professionals to assess the physical activity of this population and to develop physical activity promotion interventions adapted to their needs. This study is part of the standard management of patients with lower limb amputations and devices. In addition to the clinical data and the result of the 6-minute test from the classical management, the IPAQ-SF questionnaire will be completed twice by the patients included in this study: - Once during the consultation, - Once at home. For the only center equipped (center 01) with inertial sensors, the gait parameters during the 6-minute test will be collected in order to extract fatigue indices. Upon completion of the IPAQ-SF questionnaire a second time, the patient's participation in the study ends. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05989113
Study type Observational
Source FondationbHopale
Contact Marine Deseur
Phone 0362882780
Email marine.deseur@fondation-hopale.org
Status Recruiting
Phase
Start date May 3, 2023
Completion date September 2023

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