Psychometric Qualities IPAQ-SF (QUAPSY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Lower Extremity Amputation; Gait Analysis; Questionnaires
• Intervention / Treatment: Other: Administration of the IPAQ-SF questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marine Deseur; Phone Number: 0362882780; Email: marine.deseur@fondation-hopale.org
• Study Contact Backup: Name: Elias Ghehioueche; Email: elias.ghehioueche@chu-lille.fr

Study Locations

• France
  • Berck, France
    • Recruiting
    • Institut Calvé
    • Contact: Marine Deseur; Phone Number: 03 62 88 27 80
  • Lille, France, 59037
    • Recruiting
    • CHRU Lille - Hôpital Swynghedauw
    • Contact: Elias GHEHIOUECHE
  • Oignies, France, 62590
    • Recruiting
    • CRF les HAUTOIS- CRO
    • Contact: Elias GHEHIOUECHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Lower limb amputee patients with devices

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lower limb amputee patients with devices	Other: Administration of the IPAQ-SF questionnaire; Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the METs/week questionnaire results with the results of the 6-minute walk test	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.	Data collection during the routine consultation on the day of inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The MFCL consists of five ordered categories or 'K-levels' that define increasing functional mobility.	Data collection during the routine consultation on the day of inclusion
Relationships between the patient's weight and the IPAQ-SF score.	Patient's weight in kilogram	Data collection during the routine consultation on the day of inclusion
Relationships between type of prosthesis 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.	The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's walking speed in meters per second 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 patient's average step length measured by inertial units during the 6-minute test.	The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's average step length in centimeters 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.	The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's average step width in centimeters 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 patient's walking cadence measured by inertial units during the 6-minute test.	The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Number of steps per minute during the 6-minute test.	Data collection during the 6-minute routine consultation test on the day of inclusion
Relationships between the level of amputation and the IPAQ-SF score.	5 levels of amputation : Hip disarticulation; Transfemoral amputation; Knee disarticulation; Transtibial amputation; Trans-iliolumbar amputation	Data collection during the routine consultation on the day of inclusion
Relationships between the age of amputation and the IPAQ-SF score.	Age of amputation in years	Data collection during the routine consultation on the day of inclusion

Collaborators and Investigators

• Sponsor: FondationbHopale
• Investigators: Principal Investigator: Frédéric Charlaté, Fondation Hopale

Publications and helpful links

Helpful Links

• Deans S, Burns D, McGarry A, et al. Motivations and barriers to prosthesis users participation in physical activity, exercise and sport: a review of the literature. Prosthet Orthot Int. 2012;36:260-269.
• Hordacre, B., Barr, C., & Crotty, M. (2014). Use of an activity monitor and GPS device to assess community activity and participation in transtibial amputees. Sensors (Basel, Switzerland), 14(4), 5845-5859
• Wetterhahn, K. A., Hanson, C., & Levy, C. E. (2002). Effect of participation in physical activity on body image of amputees. American journal of physical medicine & rehabilitation, 81(3), 194-201.
• Melo, V. H., Sousa, R. A. L., Improta-Caria, A. C., & Nunes, M. A. P. (2021). Physical activity and quality of life in adults and elderly individuals with lower limb amputation. Revista da Associacao Medica Brasileira (1992), 67(7), 985-990
• da Silva, R., Rizzo, J. G., Gutierres Filho, P. J., Ramos, V., & Deans, S. (2011). Physical activity and quality of life of amputees in southern Brazil. Prosthetics and orthotics international, 35(4), 432-438.
• Del Din, S., Galna, B., Godfrey, A., Bekkers, E. M. J., Pelosin, E., Nieuwhof, F., Mirelman, A., Hausdorff, J. M., & Rochester, L. (2019). Analysis of Free-Living Gait in Older Adults With and Without Parkinson's Disease and With and Without a History of
• Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. Jou
• Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HOP23-RIPH3-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No