The Injury and Its Consequences in the Sports Lower Limb Amputee (PREV'AMP SPORT)

October 26, 2022 updated by: Centre Hospitalier Universitaire de Nīmes

This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact.

It aims to study sports-related injuries in lower limb amputees. Its objective is to determine the prevalence, but also to describe the injuries (type, location, duration, type of management) and their repercussions in terms of after-effects, and repercussions on sports, professional and personal practice. It also aims to begin a correlation between injury and sports load, type of sport (discipline, practice modality), technical aids used

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lower limb amputee or agenic lower limb with regular physical activity (at least 1x/week)

Description

Inclusion Criteria:

  • Lower limb amputee or lower limb agenes
  • Amputee before 55 years old
  • Amputee for more than 2 years
  • Willing to participate in the study
  • Practicing a regular physical activity (at least 1x/week)
  • Patient affiliated or beneficiary of a health insurance plan.
  • Patient aged 18-65 years

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lower limb amputee
No intervention, pure observational study
Other: completion of a questionnaire on the practice of sports and possible injuries
completion of a questionnaire on the practice of sports and possible injuries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of injuries
Time Frame: in the 5 years preceding the completion of the questionnaire
presence of injuries (Yes/No, if yes, Nb)
in the 5 years preceding the completion of the questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2022

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2021/GM-01
  • 2021-A01657-34 (Registry Identifier: ID-RCB (ANSM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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