Psychometric Qualities IPAQ-SF

NCT05989113 | Unknown

• 1 other identifier: HOP23-RIPH3-09
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Amputation; Lower Extremity Amputation; Gait Analysis; Questionnaires

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 patient's weight and the IPAQ-SF score.

  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 age of amputation and the IPAQ-SF score.

  Data collection during the routine consultation on the day of inclusion

Study Arms (1)

Lower limb amputee patients with devices

Other: Administration of the IPAQ-SF questionnaire

Interventions

Administration of the IPAQ-SF questionnaire OTHER

Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home

Lower limb amputee patients with devices

Eligibility Criteria

• Age: 15 Years - 69 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lower limb amputee patients with devices

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FondationbHopale: lead

Study Sites (3)

Institut Calvé

Berck, France

RECRUITING

CHRU Lille - Hôpital Swynghedauw

Lille, 59037, France

RECRUITING

CRF les HAUTOIS- CRO

Oignies, 62590, France

RECRUITING

Related 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.
• 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.
• 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 Officials

• Frédéric Charlaté

  Fondation Hopale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Deseur

CONTACT

0362882780; marine.deseur@fondation-hopale.org

Elias Ghehioueche

CONTACT

elias.ghehioueche@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: August 14, 2023
• Study Start: May 3, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-04

Locations

FR (3)