ClinicalTrials.gg
RecruitingNCT07431320COMOFOOTUpdated Aug 27, 2026

Ecological Test Standardization for Concussion Assessment in Football Players

An interventional study of Ecological Dual-Task Cognitive Assessment and Visuospatial Working Memory Ecological Test in Concussion, Brain, Sports-related Concussion and Football Players, sponsored by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape. Recruiting at 1 site in France. Open to male participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
16 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Concussion, Brain
  • Sports-related Concussion
  • Football Players
  • Traumatic Brain Injury, Mild
  • Healthy Volunteer Male Subjects

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Keywords

  • ecological test
  • reliability
  • standardization
  • cognitive assessments
03

In context

Brain Concussion

637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.

This study's planned enrollment of 100 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Professional football players:

  • Male professional football players from French clubs
  • Aged 18 years and older
  • Provided written 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Cognitive evaluation: paper-and-pencil tests and ecological tasks

    Procedure: Ecological Dual-Task Cognitive Assessment · Procedure: Visuospatial Working Memory Ecological Test

Interventions

  • ProcedureEcological 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.

  • ProcedureVisuospatial 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.

06

What researchers measure

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.

    Time frame: Day 0 to 7 : time 1 assessment

Secondary outcomes

  1. Reliability of the Ecological Tests - Intra-rater reliability

    The scores will be assigned by the same evaluator during two identical testing sessions carried out at different times and performed by 32 players. Thirty-two players will be selected from the 100 participants to complete the ecological tasks for a second time

    Time frame: Day 30 to 45 : Time 2 assessment

  2. Reliability of the Ecological Tests - Inter-rater reliability

    Correlation of results rated by two different evaluators for the same tests performed by the same 32 players. Thirty-two players will be selected from the 100 participants to repeat the ecological tasks a second time.

    Time frame: Day 0 to 7 : Time 1 assessment

  3. Correlation with Standardized Paper-and-Pencil Tests

    Correlation between scores obtained on paper-and-pencil tests and ecological tests. Visuospatial working memory, using the Corsi Block-Tapping Test Short- and long-term visual memory, using the Clinical Memory Scale (MEM-IV, Visual Reproduction I and II) Mental flexibility, using the Trail Making Test (TMT) Planning abilities, using the Tower of London test (TOL) Dual-task performance and divided attention, using Baddeley's Dual-Task Test Sustained and selective attention, using the Battery for Attention and Memory Screening - Test (BAMS-T) Affective aspects, through an anxiety questionnaire (T-FAI2) and a self-esteem questionnaire,Rosenberg Self-Esteem Scale (RSE)

    Time frame: Day 0 : Time 1 assessment

07

Study locations

1 of 1 sites recruiting
  • Centre de Kerpape
    Ploemeur, 56270, France
    Recruiting
    • Anne-Sophie DOUGUET, Neuropsychologist · Contactanne-sophie.douguet@vyv3.fr · 02.97.82.60.67
    • Charline LONGUET, CRA · Contactcharline.longuet@vyv3.fr · 02 97 82 62 93
    • Anne-Sophie DOUGUET, Neuropsychologist · Principal investigator
    • Fanny JUHEL, Physician · Sub investigator
    • Lorène MATHIEU, Physician · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.

Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 24 months is below that.

Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2026
First posted
Feb 24, 2026
StartActual
Apr 13, 2026
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2028
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07431320
Lead sponsor
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Responsible party
Sponsor
First posted
Feb 24, 2026
Start date
Apr 13, 2026
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Anne-Sophie DOUGUET, Neuropsychologist
Contact
anne-sophie.douguet@vyv3.fr
+33 2 97 82 60 67 ext. +33
Charline LONGUET, CRA
Contact
charline.longuet@vyv3.fr
0297826293 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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