Ecological Test Standardization for Concussion Assessment in Football Players

Overview

Concussion is a major concern in the sports world. It represents an immediate and transient alteration of neurological functions due to a direct or indirect trauma, with or without loss of consciousness. Concussions affect between 1.6 and 3.8 million people per year in the United States across all sports. The prevalence varies depending on the sport. In France, the incidence of sport-related concussions is estimated at 200,000 cases. According to the French Academy of Medicine (March 2025), concussions account for between 5% and 9% of all sports-related injuries. Among these cases, 30% involve individuals aged 5 to 19. Football (soccer) is one of the most affected sports, with its 2 million registered players. In French professional football (Ligue 1 and 2), during the 2023-2024 season, one concussion was recorded every 55 matches on average (declared concussion). During the 2018-2019 and 2019-2020 seasons, the rate of matches with concussion was approximately 2.5%. In professional rugby, it is estimated that one concussion occurs every three matches in France. There are no precise statistics on the number or frequency of concussions in amateur football in France, due to a lack of reporting and insufficient diagnosis. Currently, practical recommendations exist for managing football players from the moment of impact on the field, implemented within the French Football Federation. The current concussion protocol includes a standardized tool for evaluating concussion intended for healthcare professionals, the SCAT6. However, this protocol is not always sufficient, and return-to-play sometimes occurs too early. Indeed, current assessments are too brief and do not evaluate all cognitive functions. They do not allow a clear understanding of the real on-field consequences. It is estimated that 50% of athletes return to play too early after a concussion, with risks of neurological complications or prolonged symptoms. However, defining rest time and return-to-play criteria is not straightforward. In practice, return to play relies, among other things, on neuropsychological tests, whose interpretation is difficult in the absence of baseline data. The concussion protocol does not allow for an accurate determination of whether performance has normalized without this neuropsychological baseline. Recent European and international recommendations advise conducting pre-season assessments to provide comparative values. Several studies have been published on the type of pre-season assessments to perform, most using paper-and-pencil or computerized neurocognitive tests. The current concussion protocol relies mainly on paper-and-pencil tests. However, the literature shows dissociations between cognitive performance measured in ecological environments and performance measured through paper-and-pencil tests. Ecological tasks have the advantage of closely approximating the daily actions of a player and assessing cognitive functioning more precisely. Thus, these ecological tasks, combined with a baseline assessment, would improve the evaluation of athletes following a concussion. These tasks would facilitate return-to-play decisions through more objective observations and normed data. Finally, ecological tasks would enhance player monitoring and allow a more accurate understanding of their health status. For this reason, it seems necessary to develop a standardized ecological test performed in real-game situations. This would improve decision-making regarding return to play without medically endangering the player and would allow better understanding of the cognitive effects of concussion. These tasks will first be reviewed and tested by experts (players, football staff members, national concussion reference physician, and neuropsychologists) for feedback and refinement.

Interventions

• Procedure Ecological Dual-Task Cognitive Assessment
  Participants complete a dual-task on the football field combining a cognitive task of counting whistle signals and a motor task of dribbling through cones, identifying colored markers, performing juggling sequences, and shooting into a rebound board. Duration approximately 15 minutes for single tasks, 2 minutes for dual-task execution. Purpose is to evaluate and standardize cognitive performance in realistic game situations.
• Procedure Visuospatial Working Memory Ecological Test
  Participants navigate a defined space on the field, touching cones in a sequence demonstrated by the examiner with the ball at their feet. Tasks increase in difficulty and include reversing the sequence. Duration approximately 20 minutes. Purpose is to assess and norm visuospatial working memory performance in football-specific contexts.

Primary outcome measures

• Ecological Cognitive Performance Scores [Time frame: Day 0 to 7 : time 1 assessment]

Secondary outcome measures (3)

• Reliability of the Ecological Tests - Intra-rater reliability [Time frame: Day 30 to 45 : Time 2 assessment]
• Reliability of the Ecological Tests - Inter-rater reliability [Time frame: Day 0 to 7 : Time 1 assessment]
• Correlation with Standardized Paper-and-Pencil Tests [Time frame: Day 0 : Time 1 assessment]

Eligibility criteria

Inclusion criteria

Professional football players:

• Male professional football players from French clubs
• Aged 18 years and older
• Provided written informed consent to participate
• Adequate understanding of written and spoken French

Youth football players from training centers:

• Registered in a training center affiliated with a French football club
• Aged 16 years and older
• Provided written assent to participate, with parental or legal guardian consent for minors
• Adequate understanding of written and spoken French

Exclusion criteria

All players:

• History of concussion in the past 6 months (for inclusion, a statement from the club physician confirming no concussion in the past 6 months will be requested)
• Physically unfit (if applicable, a medical certificate from the club physician will be required, e.g., incapacitating musculoskeletal injury)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Centre de Kerpape — Ploemeur

Identifiers

NCT: NCT07431320 · 2025-A01392-47

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗