The TCU Division I Collegiate Athlete Study

NCT07006051 | Active Not Recruiting

• 1 other identifier: IRB#2023-124
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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. Aim 1 of this study is to investigate risk factors for orthopedic injuries from a brief testing battery developed by the research team. Aim 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. Participants will participate in a pre-season battery of tests that include:

• Balance assessment
• Jump testing
• Strength testing
• Neurocognitive testing Subjects who sustain an injury will undergo repeat testing for comparison to baseline measures. Further, retrospective chart reviews of past medical history and prospective injury tracking will be collected on all subjects.

Conditions

Orthopaedic Injuries; Concussion (Diagnosis)

Keywords

Concussion; Mild Traumatic Brain Injury; Collegiate Athlete; Orthopaedic Injury

Outcome Measures

Primary Outcomes (6)

• Movement Tests

  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.

  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)

• Sway Neurocognitive Reaction Time Testing

  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.

  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)

• Sway Neurocognitive Impulse Control Testing

  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.

  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)

• Sway Neurocognitive Cued Stroop Testing

  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.

  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)

• Concussion Prospective Injury C3 Logix

  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. 1\. C3Logix neurocognitive testing (see explanation of study procedures for information on tests)

  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)

• Concussion Prospective Injury Tracking - Symptom Reporting

  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. Collected: 1\. Subjective symptom reporting scale as designated by team physician

  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)

Secondary Outcomes (9)

• Medical History Demographics

  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)

• Medical History Current Injuries

  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)

• Past Medical History Injuries

  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)

• Medical History Medications

  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)

• Prospective Injury Tracking - Type of Injury

  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)

Study Arms (1)

Collegiate Athletes

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.

Other: Exposed group

Interventions

Exposed group OTHER

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.

Also known as: Exposure to Orthopaedic injury, Exposure to concussive injury

Collegiate Athletes

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Incoming and current NCAA division I collegiate athletes at Texas Christian University

You may qualify if:

• If they are a current National Collegiate Athletics Association (NCAA) student-athlete
• 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.

You may not qualify if:

• If they are not a current National Collegiate Athletics Association (NCAA) student-athlete
• If they are not between 17 and 30 years of age
• If they are currently experiencing an injury that limits them from completing testing procedures

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related Publications (6)

• 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: 17369562 BACKGROUND

• 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: 33948444 BACKGROUND

• 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: 28928492 BACKGROUND

• 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: 28818697 BACKGROUND

• 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: 27544666 BACKGROUND

• 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.

  PMID: 34898299 BACKGROUND

Related Links

• Countermovement Jump Example
• Drop Jump Example
• Balance Example
• Sway Neurocognitive Simple Reaction Time Testing
• Sway Neurocognitive Impulse Control Testing
• Sway Neurocognitive Selective Attention/Cued Stroop Testing
• C3 Logix Testing

MeSH Terms

Conditions

Brain Concussion; Disease

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam C King, Ph.D.

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: June 5, 2025
• Study Start: June 15, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)