Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 7:02 PM
Study NCT ID:
NCT04760834
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cessation of any sporting activity', 'timeFrame': 'Inclusion', 'description': 'Number of cessation of any sporting activity following a concussion during rugby practice, expressed as a percentage (ratio of the reported number of stops from any post-concussion sports activity to the number of rugby players reporting at least one concussion over the season).'}], 'secondaryOutcomes': [{'measure': 'Number of post-concussion medical examination', 'timeFrame': 'Inclusion', 'description': 'Reported number of post-concussion medical examination'}, {'measure': 'Number of resumption of sporting activity', 'timeFrame': 'Inclusion', 'description': 'Reported number of resumption of sporting activity carried out gradually after an initial stop in post concussion'}, {'measure': 'Number of "yes" to Players\'s knowledge on the definition of concussion', 'timeFrame': 'Inclusion', 'description': "Players's knowledge of the definition of concussion and its management"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Concussion', 'Systems thinking', 'Injury management', 'Sport-related injury', 'Rugby union', 'Mild Traumatic Brain Injury'], 'conditions': ['Cerebral Concussion']}, 'descriptionModule': {'briefSummary': 'Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Amateur rugby players', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male 18 years of age or older\n* Amateur rugby players in a club of New Aquitaine region who agreed to participate\n* Licensed with the federation for 2019/2020 or 2020/2021 season\n* Between the federal 1 and the 4th series\n\nExclusion Criteria:\n\n\\- Refusal to complete the questionnaire'}, 'identificationModule': {'nctId': 'NCT04760834', 'acronym': 'RUGBY-COM', 'briefTitle': 'Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Concussion in French Amateur Rugby: Descriptive Cross-sectional Survey About the Management and Knowledge of Players Over the 2019/2021 Seasons', 'orgStudyIdInfo': {'id': 'CHUBX 2020/10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': "Complete a questionnaire to look for signs of concussion in the past. The questions also seek to collect data on participants' knowledge, concussion management and potential confounding factors"}]}, 'contactsLocationsModule': {'locations': [{'zip': '33 076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène Cassoudesalle, Dr', 'role': 'CONTACT', 'email': 'helene.cassoudesalle@chu-bordeaux.fr', 'phone': '05 56 79 55 46'}, {'name': 'Timotey Lagisquet', 'role': 'CONTACT', 'email': 'tlagisq@gmail.com', 'phone': '06 21 73 15 45'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Hélène Cassoudesalle, Dr', 'role': 'CONTACT', 'email': 'helene.cassoudesalle@chu-bordeaux.fr', 'phone': '05 56 79 55 46'}, {'name': 'Timotey Lagisquet', 'role': 'CONTACT', 'email': 'tlagisq@gmail.com', 'phone': '06 21 73 15 45'}], 'overallOfficials': [{'name': 'Hélène Cassoudesalle, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}