Ecological Test Standardization for Concussion Assessment in Football Players
COMOFOOT
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 24, 2026
February 1, 2026
2 years
February 18, 2026
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ecological Cognitive Performance Scores
The ecological task consists of two exercises : * The first exercise is the dual-task, which involves performing two tasks separately and then simultaneously. (count sequences of whistle blows and complete a slalom between cones while dribbling the ball, gathering information (the color of a card) * The second exercise is a visuospatial memory task. It consists of touching cones while moving within a delimited space, dribbling a ball. The primary outcome measure is based on the results of the ecological tasks according to age categories: For the dual-task: task score, number of ball losses, total cone score, number of successful shots on goal, number of correct color-information responses, and percentage of correct responses to the whistle blows. For the visuospatial working-memory task: forward and backward span, total score, and number of ball losses during the course.
Day 0 to 7 : time 1 assessment
Secondary Outcomes (3)
Reliability of the Ecological Tests - Intra-rater reliability
Day 30 to 45 : Time 2 assessment
Reliability of the Ecological Tests - Inter-rater reliability
Day 0 to 7 : Time 1 assessment
Correlation with Standardized Paper-and-Pencil Tests
Day 0 : Time 1 assessment
Study Arms (1)
Cognitive evaluation: paper-and-pencil tests and ecological tasks
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- All players:
- Physically unfit (if applicable, a medical certificate from the club physician will be required, e.g., incapacitating musculoskeletal injury)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Kerpape
Ploemeur, 56270, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2026
First Posted
February 24, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02