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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365944
Other study ID # CHUBX 2023/73
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date April 20, 2026

Study information

Verified date April 2024
Source University Hospital, Bordeaux
Contact Quentin LHUAIRE
Phone 05 56 79 55 46
Email quentin.lhuaire@u-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.


Description:

Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. The short, medium and long-term issues of such impact are still debated but some studies have pointed the fact that acute concussion, repetitive concussions, and even "sub-concussive" impacts could major the risk of developing brain diseases and cognitive impairments. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol. This study will be an epidemiological descriptive and prospective study with a brief questionnaire sent off to any player, above 18 years old, male or female, that had receive a white card during an official match in the French amateur Handball league along two regular season. The results will bring details on how concussion occurs on field and how this protocol is efficient to bring the player to consult a health professional.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date April 20, 2026
Est. primary completion date April 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female - Over 18 years old - Who had received a white card during an official game - having an email address registered in the FFHB register Exclusion Criteria: - Any refusal to participate - Inability to respond

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Bordeaux University Hospital 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 Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire) Risk of concussion estimated by questionnaire collecting the following informations :
- Sport Concussion Assessment Tool 6 (SCAT6)'s 22 symptoms, each symptoms is scales from 0 to 6, 6 being the highest intensity of the symptom.
Having > 1 in at least two different symptoms is considered at risk of having a concussion
Day 0
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