Traumatic Brain Injury Clinical Trial
Official title:
Video Review of the Frequency and Assessment of Head Impacts During the FIFA World Cup 2022TM
Verified date | March 2024 |
Source | Federation Internationale de Football Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an exploratory observational study. Broadcasted video footage is used to review all head impacts during all 64 matches in the football tournament. All head impacts are registered, and simple descriptive statistics are used to create overviews of the head impact characteristics, including video signs of potential concussion, observed contact, location of the head impact, presence and timing of medical assessment, whether there was foul play and sanction, and if the player was substituted.
Status | Active, not recruiting |
Enrollment | 832 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 18, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All participating football players at the FIFA World Cup Qatar 2022. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Major League Soccer | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Federation Internationale de Football Association | Major League Soccer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of head impacts | A head impact is defined as '"a direct head impact, or impact with indirect forces to the head, where a player is unable to immediately resume play following impact or subsequently shows potential concussion-related symptoms." | November-December 2022 | |
Secondary | Number and type of video signs that indicate a potential concussion | Video signs are grouped as yellow or red flags. Yellow flags: Lying motionless Blank/vacant look Disorientation Slow go get up Dual-head impact mechanism Face or skull injury
Red flags Impact seizure/ convulsion Tonic posturing No protective action Floppy Motor incoordination Vomiting Visible concussive symptoms following return to play. Other signs: Concerning injury mechanism Uncontrolled emotional response Clutching of the head |
November-December 2022 | |
Secondary | Head impact mechanism | Direct or indirect contact is categorised according to contact involved. | November-December 2022 | |
Secondary | Location of the impact | The area of skull impact | November-December 2022 | |
Secondary | presence and timing of medical assessments | Medical assessment is defined as any apparent clinical examination, direct talk, or visual inspection while the medical person is in close range of the player. | November-December 2022 | |
Secondary | Foul play decisions | Referee decisions. | November-December 2022 | |
Secondary | Presence of substitution following head impact | Official match reports will be check substitutions and to determine whether a concussion substitution was used. | November-December 2022 |
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