Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 12:31 PM
Study NCT ID:
NCT07431320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ecological Test Standardization for Concussion Assessment in Football Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ecological Cognitive Performance Scores', 'timeFrame': 'Day 0 to 7 : time 1 assessment', 'description': 'The ecological task consists of two exercises :\n\n* 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)\n* The second exercise is a visuospatial memory task. It consists of touching cones while moving within a delimited space, dribbling a ball.\n\nThe primary outcome measure is based on the results of the ecological tasks according to age categories:\n\nFor 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.\n\nFor the visuospatial working-memory task: forward and backward span, total score, and number of ball losses during the course.'}], 'secondaryOutcomes': [{'measure': 'Reliability of the Ecological Tests - Intra-rater reliability', 'timeFrame': 'Day 30 to 45 : Time 2 assessment', 'description': 'The scores will be assigned by the same evaluator during two identical testing sessions carried out at different times and performed by 32 players.\n\nThirty-two players will be selected from the 100 participants to complete the ecological tasks for a second time'}, {'measure': 'Reliability of the Ecological Tests - Inter-rater reliability', 'timeFrame': 'Day 0 to 7 : Time 1 assessment', 'description': 'Correlation of results rated by two different evaluators for the same tests performed by the same 32 players.\n\nThirty-two players will be selected from the 100 participants to repeat the ecological tasks a second time.'}, {'measure': 'Correlation with Standardized Paper-and-Pencil Tests', 'timeFrame': 'Day 0 : Time 1 assessment', 'description': "Correlation between scores obtained on paper-and-pencil tests and ecological tests.\n\nVisuospatial 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)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ecological test', 'reliability', 'standardization', 'cognitive assessments'], 'conditions': ['Concussion, Brain', 'Sports-related Concussion', 'Football Players', 'Traumatic Brain Injury, Mild', 'Healthy Volunteer Male Subjects']}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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.\n\nHowever, 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.\n\nRecent 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.\n\nThe 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.\n\nThus, 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProfessional football players:\n\n* Male professional football players from French clubs\n* Aged 18 years and older\n* Provided written informed consent to participate\n* Adequate understanding of written and spoken French\n\nYouth football players from training centers:\n\n* Registered in a training center affiliated with a French football club\n* Aged 16 years and older\n* Provided written assent to participate, with parental or legal guardian consent for minors\n* Adequate understanding of written and spoken French\n\nExclusion Criteria:\n\nAll players:\n\n* 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)\n* Physically unfit (if applicable, a medical certificate from the club physician will be required, e.g., incapacitating musculoskeletal injury)'}, 'identificationModule': {'nctId': 'NCT07431320', 'acronym': 'COMOFOOT', 'briefTitle': 'Ecological Test Standardization for Concussion Assessment in Football Players', 'organization': {'class': 'OTHER', 'fullName': 'Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape'}, 'officialTitle': 'Ecological Test Standardization for Concussion Assessment in Football Players', 'orgStudyIdInfo': {'id': '2025-A01392-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive evaluation: paper-and-pencil tests and ecological tasks', 'interventionNames': ['Procedure: Ecological Dual-Task Cognitive Assessment', 'Procedure: Visuospatial Working Memory Ecological Test']}], 'interventions': [{'name': 'Ecological Dual-Task Cognitive Assessment', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Cognitive evaluation: paper-and-pencil tests and ecological tasks']}, {'name': 'Visuospatial Working Memory Ecological Test', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Cognitive evaluation: paper-and-pencil tests and ecological tasks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56270', 'city': 'Ploemeur', 'country': 'France', 'facility': 'Centre de Kerpape', 'geoPoint': {'lat': 47.73512, 'lon': -3.42952}}], 'centralContacts': [{'name': 'Anne-Sophie DOUGUET, Neuropsychologist', 'role': 'CONTACT', 'email': 'anne-sophie.douguet@vyv3.fr', 'phone': '+33 2 97 82 60 67', 'phoneExt': '+33'}, {'name': 'Charline LONGUET, CRA', 'role': 'CONTACT', 'email': 'charline.longuet@vyv3.fr', 'phone': '0297826293', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHU Rennes,France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}