Orthopaedic InjuriesNCT07006051
The TCU Division I Collegiate Athlete Study
An observational study of Orthopaedic Injuries and Concussion (Diagnosis), run by Texas Christian University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopaedic Injuries, Concussion (Diagnosis)
- What is being tested?
- Exposed group
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to May 2026
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Incoming and current NCAA division I collegiate athletes at Texas Christian University
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The TCU Athlete Study
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.
Read more
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:
- Demographic information, past medical history information and pre-participation examination results from University Athletics athlete health tracking system.
- 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:
- 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.
- 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.
- C3Logix neurocognitive testing (see explanation of study procedures for information on tests)
- 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:
- 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.
- 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:
- 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.
- 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.
- Conditions
- Orthopaedic Injuries, Concussion (Diagnosis)
- Being tested
- Exposed group
- Keywords
- Concussion, Mild Traumatic Brain Injury, Collegiate Athlete, Orthopaedic Injury
- Medical subject headings
- Brain Concussion, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed groupOther
Also called Exposure to Orthopaedic injury, Exposure to concussive injury
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exposed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
- C3Logix neurocognitive testing (see explanation of study procedures for information on tests)
Measured: 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:
- Subjective symptom reporting scale as designated by team physician
Measured: 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
Participant Medical History collected includes:
Demographic information from University Athletics athlete health tracking system.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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 - 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
Measured: 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 - 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
Measured: 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 - 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
Measured: 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 - 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Jun 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orthopaedic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam C King, Ph.D., Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006051
- Sponsor's protocol ID
- IRB#2023-124
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17369562Lytle 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 33948444Lemoyne 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 28928492Lapointe 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 28818697Herman 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 27544666Chandran 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TCU Athlete Study
- ClinicalTrials.gov ID
- NCT07006051
- Acronym / sponsor ID
- IRB#2023-124
- Conditions
- Orthopaedic Injuries, Concussion (Diagnosis)
- Keywords
- Concussion, Mild Traumatic Brain Injury, Collegiate Athlete, Orthopaedic Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Demographic information, past medical history information and pre-participation examination results from University Athletics athlete health tracking system.
- 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:
- 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.
- 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.
- C3Logix neurocognitive testing (see explanation of study procedures for information on tests)
- 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:
- 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.
- 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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collegiate Athletes | – | Other: Exposed groupAll 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. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Incoming and current NCAA division I collegiate athletes at Texas Christian University
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed groupAlso: Exposure to Orthopaedic injury, Exposure to concussive injuryAll 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. | Other | Collegiate Athletes |
Primary outcome
Movement 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)
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.
Sway Neurocognitive Reaction Time Testing
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)
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.
Sway Neurocognitive Impulse Control Testing
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)
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.
Sway Neurocognitive Cued Stroop Testing
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)
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.
Concussion Prospective Injury C3 Logix
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)
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)
Concussion Prospective Injury Tracking - Symptom Reporting
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)
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
9 secondary outcomes
Medical History Demographics
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)
Medical History Current Injuries
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)
Past Medical History Injuries
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)
Medical History Medications
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)
Prospective Injury Tracking - 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)
Prospective Injury Tracking - 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)
Prospective Injury Tracking - 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)
Prospective Injury Tracking - 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)
Prospective Injury Tracking - Time Missed
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 17369562Swanik 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.
- Background: PubMed 33948444Lytle 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.
- Background: PubMed 28928492Lemoyne 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.
- Background: PubMed 28818697Lapointe 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.
- Background: PubMed 27544666Herman 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.
- Background: PubMed 34898299Chandran 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.
- Countermovement Jump ExampleLink provided by the sponsor.
- Drop Jump ExampleLink provided by the sponsor.
- Balance ExampleLink provided by the sponsor.
- Sway Neurocognitive Simple Reaction Time TestingLink provided by the sponsor.
- Sway Neurocognitive Impulse Control TestingLink provided by the sponsor.
- Sway Neurocognitive Selective Attention/Cued Stroop TestingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam C King, Ph.D. principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopaedic Injuries and Concussion (Diagnosis), run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006051, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.