Concussion Assessments in Football

NCT05713942 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-11

No results posted yet for this study

Summary

Diagnosing and determining the severity of a sports-related concussion immediately on- or off-field is challenging, especially because clinical signs can evolve minutes to hours after the mechanism of injury. Hence, repeated follow-up and serial assessments of a player are recommended following such an injury.

Current advice, when a player sustains a confirmed or suspected concussive injury, is to remove them from play immediately and not return to competition or unrestricted training until signs and symptoms have been managed as per relevant guidelines. To support this decision the International football Association Board has introduced a trial allowing an additional permanent concussion substitution in participating competitions. Follow-up assessment of concussion incidents is recommended to include the Sport Concussion Assessment Tool 5th Edition. For further assessment of neurocognitive deficits and to inform return to play decisions, it is recommended that a computerised assessment is also adopted, such as the Immediate Post-Concussion Assessment and Cognitive Testing tool.

The aims of this study are:

1. To determine the incidence of head trauma and use of concussion substitutions in football competitions that are participating in the IFAB's permanent concussion substitution trial.
2. To evaluate the immediate severity of reported concussion signs and symptoms for football players with a confirmed or suspected concussion.
3. To evaluate the ability of neurocognitive assessments completed post-incident to inform the clinical diagnosis of concussion.

Conditions

  • Cerebral Concussion
  • Brain Concussion
  • Post-Concussion Symptoms
  • TBI (Traumatic Brain Injury)

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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

The ImPACT is a computer-based neurocognitive test battery that provides an objective measure of neurocognitive functioning as an assessment aid in the management of concussion in individuals ages 12-80 years

Sponsors & Collaborators

  • University of Birmingham

    collaborator OTHER
  • Federation Internationale de Football Association

    lead OTHER

Principal Investigators

  • Andreas Serner, PhD · Fédération Internationale de Football Association

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-07-01
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713942 on ClinicalTrials.gov