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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04760834
Other study ID # CHUBX 2020/10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 16, 2022
Est. completion date September 16, 2022

Study information

Verified date March 2022
Source University Hospital, Bordeaux
Contact Hélène Cassoudesalle, Dr
Phone 05 56 79 55 46
Email helene.cassoudesalle@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 16, 2022
Est. primary completion date September 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
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

Locations

Country Name City State
France CHU Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of post-concussion medical examination Reported number of post-concussion medical examination Inclusion
Secondary Number of resumption of sporting activity Reported number of resumption of sporting activity carried out gradually after an initial stop in post concussion Inclusion
Secondary Number of "yes" to Players's knowledge on the definition of concussion Players's knowledge of the definition of concussion and its management Inclusion
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