Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-13 @ 5:59 PM
Study NCT ID:
NCT03080402
Status:
UNKNOWN
Last Update Posted:
2017-03-15
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Perturbation Training for ACL Injury Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-03-20', 'releaseDate': '2019-02-23'}], 'estimatedResultsFirstSubmitDate': '2019-02-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '24 female athletes (12 with high KAM; 12 with normal KAM) will be recruited into the intervention/ testing phase of this study. Female athletes with KAM \\> 25.25 Nm will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM \\< 25.25 Nm will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vertical Jump', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Vertical jump for height'}], 'primaryOutcomes': [{'measure': 'Peak knee abduction moment', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Peak knee abduction moment during a drop jump landing task as assessed via motion analysis'}], 'secondaryOutcomes': [{'measure': 'Peak Quadriceps torque 60 degrees/sec', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Peak Quadriceps torque 60 degrees/sec'}, {'measure': 'Peak Quadriceps torque 240 degrees/sec', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Peak Quadriceps torque 240 degrees/sec'}, {'measure': 'Peak Hamstrings torque 60 degrees/sec', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Peak Hamstrings torque 60 degrees/sec'}, {'measure': 'Peak Hamstrings torque 240 degrees/sec', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Peak Hamstrings torque 240 degrees/sec'}, {'measure': 'Single hop for distance LSI', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Single hop for distance limb symmetry index'}, {'measure': 'Crossover hop for distance LSI', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Crossover hop for distance limb symmetry index'}, {'measure': 'Triple hop for distance LSI', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': 'Triple hop for distance limb symmetry index'}, {'measure': '6m Timed Hop LSI', 'timeFrame': 'baseline and 6 weeks after baseline testing', 'description': '6 meter Timed Hop limb symmetry index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament', 'ACL injury', 'Injury prevention', 'Perturbation training', 'Risk factors'], 'conditions': ['Anterior Cruciate Ligament Injury', 'ACL']}, 'descriptionModule': {'briefSummary': 'A prospective trial will be used to evaluate the efficacy of prophylactic mechanical perturbation training program. 24 female athletes who are regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 15-30 year are eligible. Using a prospective risk stratification design, female athletes with knee abduction moment (KAM) \\> 25.25 Nm from drop jump motion analysis will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM \\< 25.25 Nm from drop jump motion analysis will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.', 'detailedDescription': "Anterior cruciate ligament (ACL) injuries are prevalent in sports with female athletes at particularly high risk. Female athletes have 2-4x higher risk of ACL injury compared to their male counterparts in the same high-risk sports. Modifiable and non-modifiable risk factors play a role in the high incidence of ACL injuries in female athletes. High knee abduction moment (KAM), is a known modifiable risk factor for ACL injury risk. Female athletes with a KAM greater than 25.25 Nm have been identified as at high risk for an ACL injury. The ability to classify female athletes who are at a high risk for an ACL injury, highlights the importance of identifying modifiable risk factors that can be readily addressed by physical therapists and developing targeted treatments to potentially reduce ACL injury risk while improving functional performance.\n\nNeuromuscular training programs are treatments designed to help improve coordination, strength, and control. Such training programs have been designed to alter biomechanical and neuromuscular measures, in particular high KAM, in order to improve performance and function and thereby reduce the risk of ACL injury. Neuromuscular training programs involving plyometric exercises can reduce dynamic lower extremity valgus and limb-to-limb asymmetries in healthy female athletes. Despite the reductions in injury rates seen with performance of neuromuscular training programs, incidence of ACL injuries is remains higher than acceptable. Novel training methods are currently in development to optimize these current ACL injury prevention programs. As unanticipated perturbations may contribute to ACL injury risk, incorporating a mechanical platform device that provides unanticipated surface compliance changes (i.e. the floor lowering down below a subject's feet) into an ACL injury prevention program has the potential to optimize knee biomechanics and neuromuscular performance, including during unanticipated perturbations.\n\nMechanical perturbation has been advocated for as an effective training method to modify the sensorimotor system and restore normal neuromuscular coordination through exposing the subjects to controlled, progressive perturbations. Furthermore, mechanical perturbation has the potential to improve dynamic postural stability and control, and enhance muscle activation patterns. One advantage of mechanical perturbation devices is that they can be utilized while performing a variety of dynamic tasks such as hopping and jumping compared to static loading tasks such as standing and balancing activities. Dynamic tasks may place a greater demand on the knee joint, promoting joint stability as the subject overcomes the perturbation. Additionally, mechanical perturbation may allow physical therapists to administer random perturbations at different phases of the activities (i.e. as the subject is landing from a hop, or taking-off from a jump) that simulate real-life perturbations which occur during different functional or sporting activities.\n\nThe goal of this study is to assess the effectiveness of an intensive neuromuscular training program to reduce risk factors associated with ACL injury"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female athletes will be eligible if they are: 1) regular participants in Level 1 and 2 sports (cutting and pivoting type sports, and 2) ages 15-30 years\n\nExclusion Criteria:\n\n* History of major injury or surgery to the legs.'}, 'identificationModule': {'nctId': 'NCT03080402', 'briefTitle': 'Mechanical Perturbation Training for ACL Injury Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Mechanical Perturbation Training for ACL Injury Prevention', 'orgStudyIdInfo': {'id': 'R44HD068054', 'link': 'https://reporter.nih.gov/quickSearch/R44HD068054', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5R44HD068054', 'link': 'https://reporter.nih.gov/quickSearch/5R44HD068054', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High KAM', 'description': 'Mechanically-driven neuromuscular training. 2 times per week for 6 weeks for a total of 12 sessions. Perturbation training', 'interventionNames': ['Device: Mechanical Perturbation Training']}, {'type': 'NO_INTERVENTION', 'label': 'Normal KAM', 'description': 'No intervention'}], 'interventions': [{'name': 'Mechanical Perturbation Training', 'type': 'DEVICE', 'otherNames': ['Reactive Agility Platform Trainer 2.0', 'RAPTr'], 'description': 'The training program will consist of three stages and subjects will progress through each neuromuscular training stage.The training will consist of double- to single-limb movements with progression of jumping, hopping, and pivoting maneuvers on the perturbation device with an emphasis on proper technique and landing. The initial four sessions will focus on primarily on jumping and hopping maneuvers on double- and single-limb in the sagittal plane. The intermediate four sessions will incorporate additional medial and lateral maneuvers with the plyometric tasks. The final four sessions will incorporate rotational and pivoting activities with the maneuvers. The resultant protocol has been derived and optimized from previous published research studies and prevention techniques.', 'armGroupLabels': ['High KAM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19716', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Martha Callahan', 'role': 'CONTACT', 'email': 'mcall@udel.edu', 'phone': '302-831-6202'}, {'name': 'Lynn Snyder-Mackler, PT ATC ScD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Delaware, Physical Therapy Department', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'centralContacts': [{'name': 'Martha Callahan', 'role': 'CONTACT', 'email': 'mcall@udel.edu', 'phone': '(302) 831-6202'}], 'overallOfficials': [{'name': 'Lynn Snyder-Mackler, PT, ATC, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is currently no IPD sharing plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'collaborators': [{'name': 'Simbex, LLC', 'class': 'UNKNOWN'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alumni Distinguished Professor', 'investigatorFullName': 'Lynn Snyder-Mackler', 'investigatorAffiliation': 'University of Delaware'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-02-23', 'type': 'RELEASE'}, {'date': '2019-03-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lynn Snyder-Mackler, Alumni Distinguished Professor, University of Delaware'}}}}