Psychometric Qualities IPAQ-SF

NCT ID: NCT05989113

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-03

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Amputation Lower Extremity Amputation Gait Analysis Questionnaires

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lower limb amputee patients with devices

Administration of the IPAQ-SF questionnaire

Intervention Type OTHER

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

Interventions

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Administration of the IPAQ-SF questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FondationbHopale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Charlaté

Role: PRINCIPAL_INVESTIGATOR

Fondation Hopale

Locations

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Institut Calvé

Berck, , France

Site Status RECRUITING

CHRU Lille - Hôpital Swynghedauw

Lille, , France

Site Status RECRUITING

CRF les HAUTOIS- CRO

Oignies, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marine Deseur

Role: CONTACT

0362882780

Elias Ghehioueche

Role: CONTACT

Facility Contacts

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Marine Deseur

Role: primary

03 62 88 27 80

Elias GHEHIOUECHE

Role: primary

Elias GHEHIOUECHE

Role: primary

Related Links

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https://doi.org/10.1177/0309364612437905

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.

https://doi.org/10.1097/00002060-200203000-00007

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.

https://doi.org/10.1590/1806-9282.20210382

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

https://doi.org/10.1177/0309364611425093

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.

https://doi.org/10.1007/s00415-019-09500-z

Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. Jou

https://doi.org/10.1371/journal.pone.0158623

Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study.

Other Identifiers

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HOP23-RIPH3-09

Identifier Type: -

Identifier Source: org_study_id

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