Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT05344703
Status:
RECRUITING
Last Update Posted:
2022-04-25
First Post:
2022-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Y-Balance Test Predictive of Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group of 6th to 12th graders'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Report of concussion in past year', 'timeFrame': '1 year', 'description': 'Determine if patient sustained concussion since test date utilizing this questionnaire.'}, {'measure': 'Report of lower extremity injury in past year', 'timeFrame': '1 year', 'description': 'This will be determined utilizing intake questionnaire as developed by research team delineating joint or structure impacted by injury.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Concussion, Brain', 'Concussion; Eye']}, 'descriptionModule': {'briefSummary': "The Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. The process is repeated in the posterior medial, and the posterior lateral directions. The final values are controlled for leg length of the participants. The YBT-LQ has been shown to be predictive of lower extremity injury in high school basketball players, but it is typically used as part of a battery of tests to determine the athlete's overall injury risk, but more questions remain to be answered. The research question: Is the YBT-LQ predictive of concussion in high school athletes? What are the norms for YBT-LQ in high school athletes? Does history of concussion effect YBT-LQ? Is the YBT-LQ with visual perturbations predictive of concussions? Is the YBT-LQ with visual perturbations predictive of lower extremity injury? What is the impact of visual perturbations on Y-balance and its injury prevention capability?\n\nThe target student participants will be 9th through 12th grade students; however, 6th to 8th grade students will be allowed to participate depending on the school or organization request. Informed consent will be obtained reiterating that participation is voluntary. Testing utilizing the YBT-LQ will occur, and sport of participation, age, height, weight, dorsiflexion, and leg length will be obtained. Follow up will be made via the athletic trainers and school personnel to indicate the effected athletes. Once the post-test follow up is complete athletes will be able to see their pre-test scores, and any questions will be answered at that time. This will be a longitudinal study where testing will take place at least two times per year, preferably three times per year over 4 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participates in sport either school sanctioned or club\n\nExclusion Criteria:\n\n* History of seizure'}, 'identificationModule': {'nctId': 'NCT05344703', 'briefTitle': 'Is Y-Balance Test Predictive of Concussion', 'organization': {'class': 'OTHER', 'fullName': 'Arkansas Colleges of Health Education'}, 'officialTitle': 'Is Y-Balance Test Predictive of Concussion', 'orgStudyIdInfo': {'id': 'ArkansasCollegesHlthEd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Y Balance', 'description': 'Subjects will perform Y-balance lower quarter', 'interventionNames': ['Diagnostic Test: Y balance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Y Balance Plus Stroboscopic Glasses', 'description': 'Subjects will perform Y-balance lower quarter with and without stroboscopic lenses', 'interventionNames': ['Device: Y Balance Plus Visual Perturbations']}], 'interventions': [{'name': 'Y Balance Plus Visual Perturbations', 'type': 'DEVICE', 'description': "Stroboscopic glasses will be added to the protocol for the participants to perform the Y-balance lower quarter to examine the differences in Y-balance scores as well as examining the Y-balance's ability to predict injury and concussion with visual perturbations.", 'armGroupLabels': ['Y Balance Plus Stroboscopic Glasses']}, {'name': 'Y balance', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects will perform Y-balance without any interventional strategies.', 'armGroupLabels': ['Standard Y Balance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Habegger', 'role': 'CONTACT', 'email': 'ahabegge@gmail.com', 'phone': '402-852-6509'}], 'facility': 'Fort Smith Public Schools', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Habegger', 'role': 'CONTACT', 'email': 'ahabegge@gmail.com', 'phone': '402-852-6509'}], 'facility': 'Greenwood Public Schools', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arkansas Colleges of Health Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alex Habegger', 'investigatorAffiliation': 'Arkansas Colleges of Health Education'}}}}