Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-05 @ 2:35 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:
Texas Christian University
Organization:
Study Overview
Official Title:
The TCU Athlete Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: