Baseline Reference Values for Concussion Assessments in Football

NCT05542628 | Enrolling By Invitation

• 1 other identifier: 2
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary objective is to provide normal concussion assessment references values for use in football. All National Football Associations participating in The International Football Association Board's additional permanent substitutions trial are requested to provide baseline assessment data from players within their competitions

Conditions

Cerebral Concussion

Outcome Measures

Primary Outcomes (1)

• the Sport Concussion Assessment Tool 5th Edition (SCAT5)

  The SCAT5 is a standardized tool for use by healthcare professionals in the evaluation of individuals 13 years old or older, who are suspected of having sustained a sports-related concussion. It comprises a neuropsychological test battery that assesses attention and memory function through 8 different domains 1) Symptom number, 2) Symptom severity, 3) Orientation, 4) Immediate memory, 5) Concentration, 6) Neurological examination, 7) Balance errors, 8) Delayed recall.

  through study completion, an average of 2 years.

Secondary Outcomes (1)

• The Immediate Post-Concussion Assessment and Cognitive Testing tool version 4 (ImPACT)

  through study completion, an average of 2 years.

Interventions

No intervention included OTHER

No intervention included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The International Football Association Board (IFAB) have initiated a trial of implementing additional permanent concussion substitutions (APCS) for actual or suspected concussions. All 211 FIFA member associations (National Football Associations) are invited to participate in this trial. Participation is voluntary. The National football associations can participate with as many competitions as they wish. Competitions refer to different levels of organized leagues, as well as cup tournaments. Additionally, competitions organized by FIFA, such as the FIFA World Cup, are automatically participating in the trial.

You may qualify if:

• Male and female football players from teams in a competition participating in the concussion substitution trial.
• Players without a current suspected or confirmed concussion

You may not qualify if:

• Players less than 18 years of age.

Sponsors & Collaborators

• Federation Internationale de Football Association: lead
• University of Birmingham: collaborator

Study Sites (2)

Fèdèration Internationale de Football Association

Zurich, 8044, Switzerland

Location

The University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 15, 2022
• Study Start: January 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CH (1)