NCT05059886

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

September 17, 2021

Last Update Submit

October 26, 2022

Conditions

Leg Lower AmputationTraumatic Amputation

Keywords

sportlower limb amputation

Outcome Measures

Primary Outcomes (1)

  • prevalence of injuries

    presence of injuries (Yes/No, if yes, Nb)

    in the 5 years preceding the completion of the questionnaire

Study Arms (1)

lower limb amputee

No intervention, pure observational study

Other: completion of a questionnaire on the practice of sports and possible injuries

Interventions

completion of a questionnaire on the practice of sports and possible injuriesOTHER

completion of a questionnaire on the practice of sports and possible injuries

lower limb amputee

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

January 11, 2022

Primary Completion

June 16, 2022

Study Completion

June 16, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)