Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2023-05-03
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain
NCT03200509
What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain?
NCT02466360
Assessing the Socio-Psychological Determinants of Sagittal Balance
NCT07024121
Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain
NCT06517342
Online Physical Exercise for Chronic Low Back Pain
NCT05895630
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lower limb amputee patients with devices
Administration of the IPAQ-SF questionnaire
Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Administration of the IPAQ-SF questionnaire
Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
15 Years
69 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FondationbHopale
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frédéric Charlaté
Role: PRINCIPAL_INVESTIGATOR
Fondation Hopale
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Calvé
Berck, , France
CHRU Lille - Hôpital Swynghedauw
Lille, , France
CRF les HAUTOIS- CRO
Oignies, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Marine Deseur
Role: primary
Elias GHEHIOUECHE
Role: primary
Elias GHEHIOUECHE
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HOP23-RIPH3-09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.