Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT06083818
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2023-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-30', 'size': 317887, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-03T04:28', 'hasProtocol': True}, {'date': '2023-07-30', 'size': 2847423, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-03T04:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind masking'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CHANGING RISK FACTORS', 'timeFrame': '12 weeks', 'description': 'modification of risk factors such as dynamic knee valgus'}, {'measure': 'MOTOR CONTROL', 'timeFrame': '12 weeks', 'description': 'Changes in motor control not only of the lower limbs, but also of the lumbo-pelvic complex using software and imaging systems that measure joint alignments.'}, {'measure': 'SPORT PERFORMANCE', 'timeFrame': '12 weeks', 'description': 'Tactical and technical changes are expected on the pitch as well as improvements in the sporting performance of the players through dynamic evaluations with imaging and video systems as well as speed and agility tests by monitoring joint stability.'}, {'measure': 'KNEE JOINT BIOMECHANICS', 'timeFrame': '12 weeks', 'description': 'Changes in neuromuscular control of the knee using imaging and force plate assessments to monitor lower limb alignment and areas of increased reaction force.'}, {'measure': 'SPORTSWOMEN SATISFACTION', 'timeFrame': '12 weeks', 'description': 'Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Injuries', 'Female', 'Football'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Coves-García A, Lozano-Quijada C, Poveda-Pagán EJ. Strategies for the prevention of anterior cruciate ligament injuries in female athletes with dynamic knee valgus. Systematic review. Physiotherapy. doi:https://doi.org/10.1016/j.ft.2023.04.002.'}, {'pmid': '39881313', 'type': 'DERIVED', 'citation': 'Garcia AC, Pagan EJP. Therapeutic exercise protocol for the prevention of anterior cruciate ligament injuries in female soccer players with dynamic knee valgus (RCT). Trials. 2025 Jan 29;26(1):29. doi: 10.1186/s13063-025-08736-7.'}]}, 'descriptionModule': {'briefSummary': "Introduction: Women's football has experienced exponential growth over the last ten years. Its popularity is associated with an increase in anterior cruciate ligament injuries (ACL). They constitute a major current problem as they account for 43% of the injury burden during the sport season. Despite existing training programmes, no uniform criteria have been established to design a precise intervention protocol, with specific tasks linked to women's football, nor has it been proposed to optimise current programmes.\n\nObjective: To evaluate the efficacy of a comprehensive and specific training protocol focused on female football players with dynamic knee valgus (DKV) to prevent ACL injuries.\n\nMethodology: Randomised, double-blind, single-centre clinical trial protocol scheduled for the 2023-2024 season of women's football. There will be 2 groups: a group that will follow a specific ACL injury prevention protocol and a control group. The intervention period will last 12 weeks. Measurements will be taken at 3 time points. The biomechanics of the lower extremities, the dynamics of jumping and landing, as well as the pre and post training satisfaction of the players will be evaluated. Image capture and processing systems will be used in addition to tests such as the drop vertical jump test (DVJ), the LESS scoring system, among others.\n\nFuture expectations: This protocol aims to be one of the first to implement an ACL injury prevention programme for women football players with DKV. Despite the scarcity of research in this area, studies support beneficial effects at a preventive level."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female football players registered and federated in the corresponding team.\n* With an age range between 18 and 35 years old.\n* Minimum experience of one year playing football.\n* With DKV presence.\n\nExclusion Criteria:\n\n* Subjects with previous ACL or other ligamentous injury to the knee.\n* Subjects with a history of lower extremity injury resulting in surgery during the six months prior to the study.\n* Players with chronic illnesses that may affect test results.\n* Subjects who played other sports at a professional level.'}, 'identificationModule': {'nctId': 'NCT06083818', 'briefTitle': 'Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Therapeutic Exercise Protocol for the Prevention of Anterior Cruciate Ligament Injuries in Female Football Players With Dynamic Knee Valgus', 'orgStudyIdInfo': {'id': '04122022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this group will undergo a conventional physical preparation programme.', 'interventionNames': ['Other: Placebo - Conventional fitness programme']}, {'type': 'EXPERIMENTAL', 'label': 'ACL injury prevention protocol', 'description': 'Participants in this group will undergo a specific 12-week prevention protocol.', 'interventionNames': ['Other: Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.']}], 'interventions': [{'name': 'Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.', 'type': 'OTHER', 'description': '12-week ACL Injury Prevention Protocol', 'armGroupLabels': ['ACL injury prevention protocol']}, {'name': 'Placebo - Conventional fitness programme', 'type': 'OTHER', 'description': 'Conventional training and physical preparation programme', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03550', 'city': "Sant Joan d'Alacant", 'state': 'Alicante', 'country': 'Spain', 'facility': 'Miguel Hernandez University', 'geoPoint': {'lat': 38.40148, 'lon': -0.43623}}], 'centralContacts': [{'name': 'Amanda Coves, Physiotherapy', 'role': 'CONTACT', 'email': 'amanda.coves@goumh.umh.es', 'phone': '651120701', 'phoneExt': '+34'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Since the completion of the study and reporting of the study by publishing it in an international journal', 'ipdSharing': 'YES', 'description': 'The data concerning the age, height and weight of the participants will be shared, as well as the variables that will be measured for the subsequent execution of the study.\n\nA statistical analysis of the required variables will be carried out, in addition to explaining the data analysis system using statistical programmes. Informed consent will also be obtained from each of the participants in the study, specifying the collection of personal data for research and teaching purposes.', 'accessCriteria': 'Anyone who subscribes to the journal and who has access to the articles published in the journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amanda Coves García', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amanda Coves García', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}