Clinical trial NCT05989113: Psychometric Qualities IPAQ-SF
Official title: Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Lower Extremity Amputation
Gait Analysis
Questionnaires
Lead sponsor: FondationbHopale
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lower limb amputee patients with devices

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of the METs/week questionnaire results with the results of the 6-minute walk test
timeFrame: Data collection during the routine consultation on the day of inclusion
Secondary outcomes:
measure: Relationships between the patients ability to perform his or her expected daily functions after rehabilitation (MFCL classification, out of 5 points) and the IPAQ-SF score.
timeFrame: Data collection during the routine consultation on the day of inclusion
measure: Relationships between the level of amputation and the IPAQ-SF score.
timeFrame: Data collection during the routine consultation on the day of inclusion
measure: Relationships between the patient's weight and the IPAQ-SF score.
timeFrame: Data collection during the routine consultation on the day of inclusion
measure: Relationships between type of prosthesis and the IPAQ-SF score.
timeFrame: Data collection during the routine consultation on the day of inclusion
measure: Relationships between the age of amputation and the IPAQ-SF score.
timeFrame: Data collection during the routine consultation on the day of inclusion
measure: Relationships between the physical activity level of lower limb amputee patients and the patient's walking speed measured by inertial units during the 6-minute test.
timeFrame: Data collection during the 6-minute routine consultation test on the day of inclusion
measure: Relationship between the physical activity level of patients with lower-limb amputations and the patient's average step length measured by inertial units during the 6-minute test.
timeFrame: Data collection during the 6-minute routine consultation test on the day of inclusion
measure: Relationship between the physical activity level of patients with lower-limb amputations and the average width of the patient's step measured by inertial units during the 6-minute test.
timeFrame: Data collection during the 6-minute routine consultation test on the day of inclusion
measure: Relationship between the physical activity level of patients with lower-limb amputations and the patient's walking cadence measured by inertial units during the 6-minute test.
timeFrame: Data collection during the 6-minute routine consultation test on the day of inclusion
Other outcomes:
Locations:
city: Berck
country: France
facility: Institut Calvé
city: Lille
country: France
facility: CHRU Lille - Hôpital Swynghedauw
city: Oignies
country: France
facility: CRF les HAUTOIS- CRO
Study officials:
affiliation: Fondation Hopale
name: Frédéric Charlaté
role: PRINCIPAL_INVESTIGATOR
References: