Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-01 @ 10:51 AM
Study NCT ID:
NCT04869566
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2021-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that had occurred an injury during the last year', 'timeFrame': '12 months', 'description': 'Data on injury are collected retrospectively using a web-designed (SurveyMonkey®) registration form.'}, {'measure': 'Number of participants with one ore several mental stressors related to environmental and social conditions', 'timeFrame': '12 months', 'description': 'Mental stressors, such as club exchange, changed game system, conflict within the family, examination at school etc will be recorded using a questionnaire.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Knee Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. The athletes will record his/hers traumatic knee injury together with information about training regimes and some details on injury mechanism on a web-based form. The form also includes questions about mental stressors, such as club exchange, changed game system in addition to conflict within and outside the family, etc, prior to injury.\n\nThe present study will contribute new knowledge on levels of muscle function and different aspects of mental stress factors that may be related to traumatic knee injury in young athletes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Coaches of approximately 1400 athletes, aged 16-19 years, involved in sports related to high risk of knee injury (soccer, handball and floorball), at 70 high schools in Sweden, will be contacted and introduced to the study through email. The team coach at each school will distribute a web-based form to the athletes during their first, second or third year of the high-school period by email or through the school's intra-net system.\n\nWe estimate that approximately 300 youth athletes (50% women) will be included. From the included participants, ahtletes with traumatic knee injury will be included for furhter analysis.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and female sport high school athletes Aged 15-19 years Participating and competing in soccer, handball, or floorball\n\nExclusion Criteria:\n\nTraumatic knee injury prior to sport high school.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04869566', 'briefTitle': 'External Stressors Prior to Traumatic Knee Injury in Youth Athletes.', 'organization': {'class': 'OTHER', 'fullName': 'Linnaeus University'}, 'officialTitle': 'External Stressors Prior to Traumatic Knee Injury in Youth Athletes.', 'orgStudyIdInfo': {'id': '2019-02609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Athletes with traumatic knee injury', 'description': 'Youth athletes, aged 16-19, with traumatic knee injury'}]}, 'contactsLocationsModule': {'locations': [{'zip': '391 82', 'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Sofia Ryman Augustsson', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}], 'overallOfficials': [{'name': 'Sofia Ryman Augustsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sofia.rymanaugustsson@lnu.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linnaeus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assiociate Professor', 'investigatorFullName': 'Sofia Ryman Augustsson', 'investigatorAffiliation': 'Linnaeus University'}}}}