Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT07006051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The TCU Division I Collegiate Athlete Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement Tests', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Jumping, landing and balance tasks. Clinical analysis of double limb and single limb jumping, landing and balance on portable force plates. All physical movement and performance tests will be stopped if subject requests to stop or a significant risk of injury is identified. Tests will take approximately 10 minutes.'}, {'measure': 'Sway Neurocognitive Reaction Time Testing', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Sway Sport mobile application assessment test: Reaction time (see explanation of study procedures for information on tests). All cognitive testing will be stopped if subject requests to stop. Tests will take approximately 5 minutes.'}, {'measure': 'Sway Neurocognitive Impulse Control Testing', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Sway Sport mobile application assessment test: Impulse control (see explanation of study procedures for information on tests). All cognitive testing will be stopped if subject requests to stop. Tests will take approximately 5 minutes.'}, {'measure': 'Sway Neurocognitive Cued Stroop Testing', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Sway Sport mobile application assessment test: Selective attention (see explanation of study procedures for information on tests). All cognitive testing will be stopped if subject requests to stop. Tests will take approximately 5 minutes.'}, {'measure': 'Concussion Prospective Injury C3 Logix', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Subjects who sustain a concussion, will be identified, and diagnosed by a team physician. As part of the standard University Athletics protocol, these subjects will undergo repeat testing of the following, until they meet satisfactory baseline criteria that is decided upon by the treating physician and athletic trainer.\n\n1\\. C3Logix neurocognitive testing (see explanation of study procedures for information on tests)'}, {'measure': 'Concussion Prospective Injury Tracking - Symptom Reporting', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Subjects who sustain a concussion, will be identified, and diagnosed by a team physician. As part of the standard University Athletics protocol, these subjects will undergo repeat testing of the following, until they meet satisfactory baseline criteria that is decided upon by the treating physician and athletic trainer.\n\nCollected:\n\n1\\. Subjective symptom reporting scale as designated by team physician'}], 'secondaryOutcomes': [{'measure': 'Medical History Demographics', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Participant Medical History collected includes:\n\nDemographic information from University Athletics athlete health tracking system.'}, {'measure': 'Medical History Current Injuries', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Participant Medical History collected includes:\n\nCurrent injuries and characteristics from University Athletics athlete health tracking system and Pre-participation physical exam conducted by the University.'}, {'measure': 'Past Medical History Injuries', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Participant Past Medical History collected includes:\n\nPast injuries and characteristics from University Athletics athlete health tracking system and Pre-participation physical exam conducted by the University.'}, {'measure': 'Medical History Medications', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Participant Medical History collected includes:\n\nCurrent medications and supplements from University Athletics athlete health tracking system and Pre-participation physical exam conducted by the University.'}, {'measure': 'Prospective Injury Tracking - Type of Injury', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system:\n\nCollected:\n\nType of injury'}, {'measure': 'Prospective Injury Tracking - Location of Injury', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system:\n\nCollected:\n\nLocation of injury'}, {'measure': 'Prospective Injury Tracking - Mechanism of Injury', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system:\n\nCollected:\n\nMechanism of injury'}, {'measure': 'Prospective Injury Tracking - Severity of Injury', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system:\n\nCollected:\n\nSeverity of injury'}, {'measure': 'Prospective Injury Tracking - Time Missed', 'timeFrame': "Baseline testing will occur within the two weeks prior to the start of a sport's season, follow up testing will occur if injury exposure occurs through the study completion (up to 5 years in college setting)", 'description': 'Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system:\n\nCollected:\n\nTime missed due to injury'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Concussion', 'Mild Traumatic Brain Injury', 'Collegiate Athlete', 'Orthopaedic Injury'], 'conditions': ['Orthopaedic Injuries', 'Concussion (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '17369562', 'type': 'BACKGROUND', 'citation': 'Swanik CB, Covassin T, Stearne DJ, Schatz P. The relationship between neurocognitive function and noncontact anterior cruciate ligament injuries. Am J Sports Med. 2007 Jun;35(6):943-8. doi: 10.1177/0363546507299532. Epub 2007 Mar 16.'}, {'pmid': '33948444', 'type': 'BACKGROUND', 'citation': 'Lytle JB, Parikh KB, Tarakemeh A, Vopat BG, Mulcahey MK. Epidemiology of Foot and Ankle Injuries in NCAA Jumping Athletes in the United States During 2009-2014. Orthop J Sports Med. 2021 Apr 16;9(4):2325967121998052. doi: 10.1177/2325967121998052. eCollection 2021 Apr.'}, {'pmid': '28928492', 'type': 'BACKGROUND', 'citation': 'Lemoyne J, Poulin C, Richer N, Bussieres A. Analyzing injuries among university-level athletes: prevalence, patterns and risk factors. J Can Chiropr Assoc. 2017 Aug;61(2):88-95.'}, {'pmid': '28818697', 'type': 'BACKGROUND', 'citation': 'Lapointe AP, Nolasco LA, Sosnowski A, Andrews E, Martini DN, Palmieri-Smith RM, Gates DH, Broglio SP. Kinematic differences during a jump cut maneuver between individuals with and without a concussion history. Int J Psychophysiol. 2018 Oct;132(Pt A):93-98. doi: 10.1016/j.ijpsycho.2017.08.003. Epub 2017 Aug 14.'}, {'pmid': '27544666', 'type': 'BACKGROUND', 'citation': 'Herman DC, Jones D, Harrison A, Moser M, Tillman S, Farmer K, Pass A, Clugston JR, Hernandez J, Chmielewski TL. Concussion May Increase the Risk of Subsequent Lower Extremity Musculoskeletal Injury in Collegiate Athletes. Sports Med. 2017 May;47(5):1003-1010. doi: 10.1007/s40279-016-0607-9.'}, {'pmid': '34898299', 'type': 'BACKGROUND', 'citation': 'Chandran A, Boltz AJ, Morris SN, Robison HJ, Nedimyer AK, Collins CL, Register-Mihalik JK. Epidemiology of Concussions in National Collegiate Athletic Association (NCAA) Sports: 2014/15-2018/19. Am J Sports Med. 2022 Feb;50(2):526-536. doi: 10.1177/03635465211060340. Epub 2021 Dec 13.'}], 'seeAlsoLinks': [{'url': 'https://valdperformance.com/news/understanding-the-countermovement-jump', 'label': 'Countermovement Jump Example'}, {'url': 'https://support.vald.com/hc/en-au/articles/4999913990425-ForceDecks-Test-Drop-Jump-Protocol', 'label': 'Drop Jump Example'}, {'url': 'https://vimeo.com/647588020', 'label': 'Balance Example'}, {'url': 'https://www.youtube.com/watch?v=RuTK4EbY8p0', 'label': 'Sway Neurocognitive Simple Reaction Time Testing'}, {'url': 'https://www.youtube.com/watch?v=NDH7CRP9pYY', 'label': 'Sway Neurocognitive Impulse Control Testing'}, {'url': 'https://www.linkedin.com/posts/swaymedical_swaytests-cuedstroop-activity-6971499487592681473-j5dR?trk=public_profile_like_view', 'label': 'Sway Neurocognitive Selective Attention/Cued Stroop Testing'}, {'url': 'https://www.youtube.com/watch?v=eBcI7Br1c5w', 'label': 'C3 Logix Testing'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to identify risk factors for two of the most common types of injuries in collegiate athletics - orthopedic injuries and concussion injuries.\n\nAim 1 of this study is to investigate risk factors for orthopedic injuries from a brief testing battery developed by the research team.\n\nAim 2 of this study is to investigate risk factors for concussion injuries and subsequent sequelae after returning to play from concussion from the same brief testing battery developed by the research team. Additionally, we will examine the relationships between orthopedic injuries and concussion injuries in the collegiate athlete.\n\nParticipants will participate in a pre-season battery of tests that include:\n\n* Balance assessment\n* Jump testing\n* Strength testing\n* Neurocognitive testing Subjects who sustain an injury will undergo repeat testing for comparison to baseline measures.\n\nFurther, retrospective chart reviews of past medical history and prospective injury tracking will be collected on all subjects.', 'detailedDescription': 'The study involves a total of one to three visits, depending on whether an athlete sustains an injury. If an enrolled athlete does not sustain an injury during their athletic season, they will only complete visit 1. If they do, they will complete visits 1, 2, and 3. In total, the expected time requirement is less than 1 hour across the season.\n\nThis study will be a two year project in which athletes will be tested around the beginning of their respective sport season.\n\nThe PI or Co-I will ask the potential study participant questions regarding inclusion/exclusion criteria. If the potential participant meets all inclusion criteria and no exclusion criteria exist, then the informed consent process can begin. The PI or Co-I will review the informed consent document with the participant. If the participant agrees to be a part of the research study, then the informed consent and authorization form (HIPAA) will be signed electronically.\n\nAs part of the 1st Aim of the study: 1 visit, approximately 15 minutes\n\nInformation to be collected after consent but does not require the subject to be present:\n\n1. Demographic information, past medical history information and pre-participation examination results from University Athletics athlete health tracking system.\n2. Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system; Such data that will be collected includes but is not limited to: type of injury, location of injury, mechanism of injury, severity of injury, and time missed due to injury.\n\nInitial Pre-season visit (approximately 15 minutes)\n\nAll subjects will perform:\n\n1. Sway Sport mobile application assessment tests: reaction time, impulse control, and selective attention (see explanation of study procedures for information on tests). All cognitive testing will be stopped if subject requests to stop. Tests will take approximately 5 minutes.\n2. Movement tests: jumping, landing and balance tasks (see explanation of study procedures for information on tests). All physical movement and performance tests will be stopped if subject requests to stop or a significant risk of injury is identified. Tests will take approximately 10 minutes.\n\nInitial pre-season testing should take approximately 15 minutes for actual testing with time requirement of no more than 30 minutes if completing testing in a group setting.\n\nFor athletes who sustain non-concussive injuries, standard of care rehab assessments will be collected over the course of recovery and at time of return to play by the treating physical therapist or athletic trainer. These standard of care measures utilized will be up to the rehabilitation provider in their practice and will not add time nor commitment from a research perspective for study participants but may be collected as data to describe injury and recovery characteristics.\n\nAs part of the 2nd Aim of the study: 2 additional visits, approximately 15 minutes each Subjects who sustain a concussion, will be identified, and diagnosed by a team physician. As part of the standard University Athletics protocol, these subjects will undergo repeat testing of the following, until they meet satisfactory baseline criteria that is decided upon by the treating physician and athletic trainer.\n\n1. C3Logix neurocognitive testing (see explanation of study procedures for information on tests)\n2. Subjective symptom reporting scale as designated by team physician\n\nAs part of the study protocol, these subjects will be asked to return for the following repeat testing:\n\n2nd Visit - during week following concussive injury (approximately 15 minutes)\n\nOnly subjects that sustain a concussion will perform:\n\n1. Sway Sport mobile application assessment tests: reaction time, impulse control, and selective attention. All cognitive testing will be stopped if subject requests to stop. Tests will take approximately 5 minutes.\n2. Movement tests: jumping, landing and balance tasks. All physical movement and performance tests will be stopped if subject requests to stop or a significant risk of injury is identified. Tests will take approximately 10 minutes.\n\n3rd Visit - at time of return to play following concussive injury (approximately 15 minutes)\n\nOnly subjects that sustain a concussion will perform:\n\n1. Sway Sport mobile application assessment tests: reaction time, impulse control, and selective attention. All cognitive testing will be stopped if subject requests to stop. Tests will take approximately 5 minutes.\n2. Movement tests: jumping, landing and balance tasks. All physical movement and performance tests will be stopped if subject requests to stop or a significant risk of injury is identified. Tests will take approximately 10 minutes.\n\nFor athletes who sustain a concussive and/or any non-concussive injuries, standard of care rehab assessments will be collected over the course of recovery and at time of return to play by treating physical therapist or athletic trainer. These standard of care measures utilized will be up to the rehabilitation provider in their practice and will not add time nor commitment from a research perspective for study participants but may be collected as data to describe injury and recovery characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Incoming and current NCAA division I collegiate athletes at Texas Christian University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If they are a current National Collegiate Athletics Association (NCAA) student-athlete\n* If they are between 17 and 30 years of age - with recent extensions in eligibility requirements for NCAA sports, athletes are participating at increasingly higher ages. Similarly, early enrollees are common and can be included in the study prior to turning 18.\n\nExclusion Criteria:\n\n* If they are not a current National Collegiate Athletics Association (NCAA) student-athlete\n* If they are not between 17 and 30 years of age\n* If they are currently experiencing an injury that limits them from completing testing procedures'}, 'identificationModule': {'nctId': 'NCT07006051', 'briefTitle': 'The TCU Division I Collegiate Athlete Study', 'organization': {'class': 'OTHER', 'fullName': 'Texas Christian University'}, 'officialTitle': 'The TCU Athlete Study', 'orgStudyIdInfo': {'id': 'IRB#2023-124'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Collegiate Athletes', 'description': 'All subjects must be current NCAA Division 1 collegiate level athletes at Texas Christian University. Subject testing will include: neurocognitive tests, balance tests, jump tests, strength tests.', 'interventionNames': ['Other: Exposed group']}], 'interventions': [{'name': 'Exposed group', 'type': 'OTHER', 'otherNames': ['Exposure to Orthopaedic injury', 'Exposure to concussive injury'], 'description': 'All subjects are tested pre-season for their sport. They are then prospectively followed for orthopaedic and/or concussive injury. If injuries occur, then repeat testing is performed.', 'armGroupLabels': ['Collegiate Athletes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76129', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Christian University', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Adam C King, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Christian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Christian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}