NCT05629169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
832

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

February 11, 2025

Status Verified

March 1, 2024

Enrollment Period

28 days

First QC Date

November 17, 2022

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number and type of video signs that indicate a potential concussion

    November-December 2022

  • Head impact mechanism

    November-December 2022

  • Location of the impact

    November-December 2022

  • presence and timing of medical assessments

    November-December 2022

  • Foul play decisions

    November-December 2022

  • +1 more secondary outcomes

Interventions

Observational study only. All head impacts will be assessed using video footage.

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The FIFA World Cup Qatar 2022 includes 32 national teams, and each team is allowed to select 26 players, giving at total of 832 potential participants. In total, 64 matches will be played over 29 days.

You may qualify if:

  • All participating football players at the FIFA World Cup Qatar 2022.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Major League Soccer

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Craniocerebral TraumaBrain ConcussionBrain InjuriesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain DiseasesCentral Nervous System DiseasesHead Injuries, ClosedWounds, Nonpenetrating

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 29, 2022

Study Start

November 20, 2022

Primary Completion

December 18, 2022

Study Completion

October 7, 2024

Last Updated

February 11, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared as it contains a high risk of exposing identifiable information.

Locations