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Active, not recruitingNCT07006051Updated Jun 5, 2025

The TCU Division I Collegiate Athlete Study

An observational study in Orthopaedic Injuries and Concussion (Diagnosis), sponsored by Texas Christian University. Active, not recruiting at 1 site in United States. Open to participants aged 17 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Texas Christian University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
17 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed description

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.

This study will be a two year project in which athletes will be tested around the beginning of their respective sport season.

The 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.

As part of the 1st Aim of the study: 1 visit, approximately 15 minutes

Information to be collected after consent but does not require the subject to be present:

  1. Demographic information, past medical history information and pre-participation examination results from University Athletics athlete health tracking system.
  2. 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.

Initial Pre-season visit (approximately 15 minutes)

All subjects will perform:

  1. 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.
  2. 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.

Initial 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.

For 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.

As 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.

  1. C3Logix neurocognitive testing (see explanation of study procedures for information on tests)
  2. Subjective symptom reporting scale as designated by team physician

As part of the study protocol, these subjects will be asked to return for the following repeat testing:

2nd Visit - during week following concussive injury (approximately 15 minutes)

Only subjects that sustain a concussion will perform:

  1. 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.
  2. 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.

3rd Visit - at time of return to play following concussive injury (approximately 15 minutes)

Only subjects that sustain a concussion will perform:

  1. 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.
  2. 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.

For 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.

02

Conditions studied

  • Orthopaedic Injuries
  • Concussion (Diagnosis)

Browse trials for

Keywords

  • Concussion
  • Mild Traumatic Brain Injury
  • Collegiate Athlete
  • Orthopaedic Injury
03

In context

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's planned enrollment of 500 is above the median of 180 across 146 observational studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Texas Christian University is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherExposed group

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

  2. 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.

    Time frame: 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)

  3. 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.

    Time frame: 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)

  4. 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.

    Time frame: 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)

  5. 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)

    Time frame: 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)

  6. 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

    Time frame: 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

  1. Medical History Demographics

    Participant Medical History collected includes: Demographic information from University Athletics athlete health tracking system.

    Time frame: 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)

  2. Medical History Current Injuries

    Participant Medical History collected includes: Current injuries and characteristics from University Athletics athlete health tracking system and Pre-participation physical exam conducted by the University.

    Time frame: 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)

  3. Past Medical History Injuries

    Participant Past Medical History collected includes: Past injuries and characteristics from University Athletics athlete health tracking system and Pre-participation physical exam conducted by the University.

    Time frame: 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)

  4. Medical History Medications

    Participant Medical History collected includes: Current medications and supplements from University Athletics athlete health tracking system and Pre-participation physical exam conducted by the University.

    Time frame: 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)

  5. Prospective Injury Tracking - Type of Injury

    Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system: Collected: Type of injury

    Time frame: 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)

  6. Prospective Injury Tracking - Location of Injury

    Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system: Collected: Location of injury

    Time frame: 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)

  7. Prospective Injury Tracking - Mechanism of Injury

    Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system: Collected: Mechanism of injury

    Time frame: 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)

  8. Prospective Injury Tracking - Severity of Injury

    Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system: Collected: Severity of injury

    Time frame: 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)

  9. Prospective Injury Tracking - Time Missed

    Injury occurrence and characteristics during the yearlong season will be tracked and recorded by team athletic trainers and inputted into athlete health tracking system: Collected: Time missed due to injury

    Time frame: 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)

07

Study locations

1 site
  • Texas Christian University
    Fort Worth, Texas 76129, United States
08

References and documents

Publications

  • 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. PubMed 17369562 ↗
  • 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. PubMed 33948444 ↗
  • 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. PubMed 28928492 ↗
  • 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. PubMed 28818697 ↗
  • 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. PubMed 27544666 ↗
  • 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. PubMed 34898299 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07006051
Lead sponsor
Texas Christian University
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Jun 15, 2023
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Jun 5, 2025

Study contacts

Adam C King, Ph.D.
principal investigator · Texas Christian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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