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Clinical Trials/NCT05989113
NCT05989113
Recruiting
Not Applicable

Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)

FondationbHopale3 sites in 1 country100 target enrollmentMay 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation
Sponsor
FondationbHopale
Enrollment
100
Locations
3
Primary Endpoint
Correlation of the METs/week questionnaire results with the results of the 6-minute walk test
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2023
End Date
September 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
FondationbHopale
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Correlation of the METs/week questionnaire results with the results of the 6-minute walk test

Time Frame: Data collection during the routine consultation on the day of inclusion

The results of the IPAQ-SF questionnaire will be expressed in METs/week (Metabolic Equivalent of Task). The distance covered by the patient at the end of the 6-minute test will be collected in meters.

Secondary Outcomes

  • Relationships between type of prosthesis and the IPAQ-SF score.(Data collection during the routine consultation on the day of inclusion)
  • 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.(Data collection during the 6-minute routine consultation test on the day of inclusion)
  • Relationships between the age of amputation and the IPAQ-SF score.(Data collection during the routine consultation on the day of inclusion)
  • Relationships between the patient's weight and the IPAQ-SF score.(Data collection during the routine consultation on the day of inclusion)
  • 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.(Data collection during the 6-minute routine consultation test on the day of inclusion)
  • 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.(Data collection during the routine consultation on the day of inclusion)
  • Relationships between the level of amputation and the IPAQ-SF score.(Data collection during the routine consultation on the day of inclusion)
  • 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.(Data collection during the 6-minute routine consultation test on the day of inclusion)
  • 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.(Data collection during the 6-minute routine consultation test on the day of inclusion)

Study Sites (3)

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