- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760834
Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players (RUGBY-COM)
March 29, 2022 updated by: University Hospital, Bordeaux
Concussion in French Amateur Rugby: Descriptive Cross-sectional Survey About the Management and Knowledge of Players Over the 2019/2021 Seasons
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hélène Cassoudesalle, Dr
- Phone Number: 05 56 79 55 46
- Email: helene.cassoudesalle@chu-bordeaux.fr
Study Contact Backup
- Name: Timotey Lagisquet
- Phone Number: 06 21 73 15 45
- Email: tlagisq@gmail.com
Study Locations
-
-
-
Bordeaux, France, 33 076
- Recruiting
- CHU Bordeaux
-
Contact:
- Hélène Cassoudesalle, Dr
- Phone Number: 05 56 79 55 46
- Email: helene.cassoudesalle@chu-bordeaux.fr
-
Contact:
- Timotey Lagisquet
- Phone Number: 06 21 73 15 45
- Email: tlagisq@gmail.com
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Amateur rugby players
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal to complete the questionnaire
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of cessation of any sporting activity
Time Frame: Inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of post-concussion medical examination
Time Frame: Inclusion
|
Reported number of post-concussion medical examination
|
Inclusion
|
Number of resumption of sporting activity
Time Frame: Inclusion
|
Reported number of resumption of sporting activity carried out gradually after an initial stop in post concussion
|
Inclusion
|
Number of "yes" to Players's knowledge on the definition of concussion
Time Frame: Inclusion
|
Players's knowledge of the definition of concussion and its management
|
Inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hélène Cassoudesalle, Dr, University Hospital, Bordeaux
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)
March 16, 2022
Primary Completion (Anticipated)
September 16, 2022
Study Completion (Anticipated)
September 16, 2022
Study Registration Dates
First Submitted
February 15, 2021
First Submitted That Met QC Criteria
February 15, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2020/10
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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