Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-02-03 @ 10:06 PM
Study NCT ID:
NCT04110002
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2019-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Injury Prevention Program for Professional Ballet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arm: randomized to injury prevention protocol or control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Injury', 'timeFrame': '1 year', 'description': 'Number of injuries sustained and reported per subject during the 1 year study. Data will be aggregated according to arm of study to ascertain the rate of injury for each group.'}], 'secondaryOutcomes': [{'measure': 'Turn-out degrees', 'timeFrame': '1 year', 'description': 'Turn-out degree values to measure flexibility and strength. Turnout is the sum of hip rotation, tibial torsion, and contributions from the foot.'}, {'measure': 'Beighton', 'timeFrame': '1 year', 'description': 'Beighton scale to ascertain generalized joint laxity. Maximum score of 9, minimum score of 0.'}, {'measure': 'AOFAS ankle-hindfoot', 'timeFrame': '1 year', 'description': "American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score. 100 point total score. Instrument combines functional outcome and pain for subject's ankle or hindfoot."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['injury prevention program; professional ballet'], 'conditions': ['Accidents Sports', 'Injury Prevention']}, 'referencesModule': {'references': [{'pmid': '32782904', 'type': 'DERIVED', 'citation': 'Vera AM, Barrera BD, Peterson LE, Yetter TR, Dong D, Delgado DA, McCulloch PC, Varner KE, Harris JD. An Injury Prevention Program for Professional Ballet: A Randomized Controlled Investigation. Orthop J Sports Med. 2020 Jul 28;8(7):2325967120937643. doi: 10.1177/2325967120937643. eCollection 2020 Jul.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Professional Ballet Dancer\n* Willing to participate and undergo informed consent process\n\nExclusion Criteria:\n\n* Pregnant Women, non-English speaking subjects, or those who decline participation in the study.'}, 'identificationModule': {'nctId': 'NCT04110002', 'briefTitle': 'An Injury Prevention Program for Professional Ballet', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation', 'orgStudyIdInfo': {'id': 'Pro00014833'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injury Prevention Program', 'description': 'Those allocated to the injury prevention program will be instructed on the program, the added exercises, and the additional time commitment.', 'interventionNames': ['Behavioral: Injury Prevention Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "The control group will practice and perform with no change to pre-existing years' standard operating practice."}], 'interventions': [{'name': 'Injury Prevention Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Injury Prevention Program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joshua D Harris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to privacy concerns, no individual participant data will be available. Only aggregate data may be provided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joshua D Harris, MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}