Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT03594669
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Training for Injury Prevention in Collegiate Soccer Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking will be used'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study will be conducted as pilot of a one-arm intervention using,1) pre- and post-participation measures of sensorimotor control and 2) injury incidence rate over the sports-season directly after completion of the intervention compared to injury incidence rate of a historical control (the 2017 soccer season at Mississippi College). Participants will include men and women athletes on soccer teams from one Division II institution.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical measures of sensorimotor control', 'timeFrame': 'Pre to post-treatment (1 month)', 'description': 'Clinical examination tests'}], 'secondaryOutcomes': [{'measure': 'Injury incidence rate', 'timeFrame': '1 year', 'description': "b) The incidence rate ratio of injury rates between a historical control (2017 soccer season) and the 2018 soccer-season from the participating college's soccer teams."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Athletic Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.', 'detailedDescription': 'The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve and injury incidence rate will decrease after participation in an intervention aimed at restoration/refinement of sensorimotor control. This study will be conducted as a 1-arm intervention with pre- and post-participation measurement of sensorimotor control and completion of an exercise intervention. Statistical analyses will be completed to determine within group change pre-to post-intervention and injury risk by comparing injury rate in 2018 to injury rate of a historical control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College\n\nExclusion Criteria:\n\n* Any athlete who has a current diagnosis of concussion (i.e. a non-medically cleared concussion), lower-extremity musculoskeletal injury, or other medical diagnosis that will prevent the athlete from participation in the intervention.'}, 'identificationModule': {'nctId': 'NCT03594669', 'briefTitle': 'Training for Injury Prevention in Collegiate Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Sensorimotor Training for Injury Prevention in Collegiate Soccer Players', 'orgStudyIdInfo': {'id': '17-0232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'When enrolled into the study, the participants will be asked to join a group in WhatsApp for purposes of the research study. The application will be used to: deliver reminders for each treatment session; deliver daily prompts for the home exercise program; and present a web-link to the home exercise program (HEP).\n\nParticipants will receive physical therapist delivered multi-modal sensorimotor training interventions. The exercises delivered at each intervention will be delivered in a group format, using a circuit of exercises that each athlete will complete in a session. Subsequent sessions will build upon previous sessions to work the sensorimotor control system in progressively more challenging and sport-specific scenarios. This present study will complete 8 sessions over 4 weeks.', 'interventionNames': ['Other: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'OTHER', 'description': 'Multi-modal sensorimotor training interventions, including vestibular, oculomotor, neuromotor, and postural control/ balance exercises.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Jennifer C Reneker, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mississippi College', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer C. Reneker', 'investigatorAffiliation': 'University of Mississippi Medical Center'}}}}