Psychometric Qualities IPAQ-SF (QUAPSY)

FondationbHopale

Status: Enrolling

Conditions: Gait Analysis; Questionnaires; Amputation; Lower Extremity Amputation

Treatments: Other: Administration of the IPAQ-SF questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05989113

HOP23-RIPH3-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have undergone a major lower limb amputation: transtibial, transfemoral, hip or knee disarticulation or trans-iliolumbar
• Fitting more than 1 year old
• Age 15-69 years (IPAQ-SF not validated outside these ages)
• All causes of amputation (vascular, traumatic, tumor, infectious...)
• Patient having given their informed consent
• Patient affiliated to a social security system

Exclusion criteria

• Subjects with bilateral amputations
• Inability to fully and adequately understand the questionnaire (i.e., cognitive impairment, patient does not speak French)
• Contraindication to the 6-minute walk test (chest pain, palpitations, mental confusion or lack of coordination and balance, dizziness or malaise, intolerable dyspnea, leg cramps or extreme leg muscle fatigue, any other clinically justified reason).
• Patients under legal protection (under guardianship, under curatorship, safeguard of justice)
• Pregnant or breast-feeding woman

Trial design

100 participants in 1 patient group

Lower limb amputee patients with devices

Treatment:

Other: Administration of the IPAQ-SF questionnaire