Community-Engaged Sport Safety - Aim 1 and Aim 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Number of Head Impacts
研究概览
简要总结
Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. In aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. The football coaches of each team will be prospectively recruited and enrolled. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Baseline and post-season neurocognitive data will be collected.
详细描述
This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team & coach), and community levels (built & social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.
排除标准
- •Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).
结局指标
主要结局
Number of Head Impacts
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Number of Impacts Per Player Per Minute
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. Number of impacts per player per minute
Mean Number of Impacts Per Athlete Per Practice
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
95th Percentile Number of Impacts Per Athlete Per Practice
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
95th Percentile Linear Acceleration (g)
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration.
Median Linear Acceleration (g)
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.
Median Rotational Acceleration
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.
Median Rotational Velocity
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.
95th Percentile Rotational Acceleration
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration.
95th Percentile Rotational Velocity
时间窗: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity.
次要结局
- Feasibility of Intervention Measure (FIM)(Month 3)
- Acceptability of Intervention Measure (AIM)(Month 3)
- Percentage of Practices the Intervention Was Implemented as Prescribed(Month 3)
- Number Changes to the Intervention(Month 3)
- Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing(Baseline)
- Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing(Baseline)
- (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score(Baseline)
- (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score(Month 3)
- (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score(Month 3)
- NIH Toolbox List Sorting Working Memory Test Score(Month 3)
- NIH Toolbox Picture Sequence Memory Test Score(Baseline and month 3)
- Rey Auditory Verbal Learning Test Score (RAVLT)(Month 3)
- Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score(Month 3)
- NIH Toolbox Picture Vocabulary Test Score(Month 3)
- Postural Control - Anterior-Posterior Postural Sway Score(Baseline and month 3)
- Postural Control - Medial-Lateral Postural Sway Score(Baseline and month 3)
- Postural Control - Maximum Path Velocity Score(Baseline and month 3)
- Postural Control - Center of Pressure Area Score(Baseline and month 3)
- Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits(Month 3)
- Vestibular/Ocular Motor Screening (VOMS) - Convergence(Baseline)
- Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades(Month 3)
- Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity(Month 3)
- Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades(Month 3)
- Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex(Month 3)
- Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence(Month 3)
- Conners' Continuous Performance Test (CPT) - Reaction Speed(Month 3)
- Conners' Continuous Performance Test (CPT)) - Omissions(Baseline)
- Conners' Continuous Performance Test (CPT) - Omissions(Month 3)
- Conners' Continuous Performance Test (CPT) - Commissions(Month 3)
- Conners' Continuous Performance Test (CPT) - Perseverations(Month 3)
- Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score(Month 3)
- NIH Toolbox Pattern Comparison Test Score(Month 3)
- (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score(Month 3)
- (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score(Month 3)