Cerebral ConcussionRUGBY-COMNCT04760834
Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players
An observational study of Cerebral Concussion, run by University Hospital, Bordeaux at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cerebral Concussion
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2022to 16 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Amateur rugby players
Who may be able to join
- 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
Who cannot join
- Refusal to complete the questionnaire
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, 33 076
Hélène Cassoudesalle, Dr, 05 56 79 55 46, helene.cassoudesalle@chu-bordeaux.fr
Timotey Lagisquet, 06 21 73 15 45, tlagisq@gmail.com
About this study
Official title: 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.
- Conditions
- Cerebral Concussion
- Being tested
- Questionnaire
- Keywords
- Cerebral Concussion, Systems thinking, Injury management, Sport-related injury, Rugby union, Mild Traumatic Brain Injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Inclusion
Secondary outcomes (3)
Number of post-concussion medical examination
Reported number of post-concussion medical examination
Measured: Inclusion
Number of resumption of sporting activity
Reported number of resumption of sporting activity carried out gradually after an initial stop in post concussion
Measured: Inclusion
Number of "yes" to Players's knowledge on the definition of concussion
Players's knowledge of the definition of concussion and its management
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start16 Mar 2022
- Primary completion16 Sep 2022 (estimated)
- Study completion16 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral ConcussionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Cassoudesalle, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760834
- Sponsor's protocol ID
- CHUBX 2020/10
- Acronym
- RUGBY-COM
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concussion in French Amateur Rugby: Descriptive Cross-sectional Survey About the Management and Knowledge of Players Over the 2019/2021 Seasons
- ClinicalTrials.gov ID
- NCT04760834
- Acronym / sponsor ID
- RUGBY-COM / CHUBX 2020/10
- Conditions
- Cerebral Concussion
- Keywords
- Cerebral Concussion, Systems thinking, Injury management, Sport-related injury, Rugby union, Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 Sep 2022 (estimated)
- Study completion
- 16 Sep 2022 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Amateur rugby players
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to complete the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireComplete 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 | Other | – |
Primary outcome
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).
3 secondary outcomes
Number of post-concussion medical examination
Time frame: Inclusion
Number of resumption of sporting activity
Time frame: Inclusion
Number of "yes" to Players's knowledge on the definition of concussion
Time frame: Inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Cassoudesalle, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Concussion, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Cassoudesalle, Dr (05 56 79 55 46, helene.cassoudesalle@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cessation of any sporting activity (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.