NCT04760834

Brief Summary

Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 16, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

February 15, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

Cerebral ConcussionSystems thinkingInjury managementSport-related injuryRugby unionMild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Number of cessation of any sporting activity

    Number of cessation of any sporting activity following a concussion during rugby practice, expressed as a percentage (ratio of the reported number of stops from any post-concussion sports activity to the number of rugby players reporting at least one concussion over the season).

    Inclusion

Secondary Outcomes (3)

  • Number of post-concussion medical examination

    Inclusion

  • Number of resumption of sporting activity

    Inclusion

  • Number of "yes" to Players's knowledge on the definition of concussion

    Inclusion

Interventions

Complete a questionnaire to look for signs of concussion in the past. The questions also seek to collect data on participants' knowledge, concussion management and potential confounding factors

Eligibility Criteria

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

Amateur rugby players

You may qualify if:

  • Male 18 years of age or older
  • Amateur rugby players in a club of New Aquitaine region who agreed to participate
  • Licensed with the federation for 2019/2020 or 2020/2021 season
  • Between the federal 1 and the 4th series

You may not qualify if:

  • \- Refusal to complete the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, 33 076, France

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hélène Cassoudesalle, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timotey Lagisquet

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 18, 2021

Study Start

March 16, 2022

Primary Completion

September 16, 2022

Study Completion

September 16, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations