The TCU Athlete Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Movement Tests
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 17 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Movement Tests
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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))
- Prospective Injury Tracking - Location 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))
- Prospective Injury Tracking - Mechanism 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))
- Prospective Injury Tracking - Severity 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))
- Prospective Injury Tracking - Time Missed(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))