Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of practice head acceleration events
研究概览
简要总结
The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein.
详细描述
Coaches of teams at the 12U and 13U levels within the six youth football organizations will be invited to pilot test the intervention program. Intervention outcomes will be compared to historic controls (K25HD101686 - NCT04908930). Video taken at all practices will be used to monitor team activities of 12U and 13U teams across all organizations participating in the intervention; incidence of injuries will be monitored across all teams. Athletes (n=30) enrolled across two of six participating teams will be recruited to participate in parallel biomechanical and video data collection to evaluate the frequency and severity of head impacts experienced throughout the season. Biomechanical data will be collected using instrumented mouth guards and verified with video. Preliminary effectiveness will be measured by the percentage of coaches who choose to adopt and maintain the intervention program. Head impact exposure and injury rates will be compared across the intervention and control teams.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 practice head acceleration events
时间窗: Month 3
Number of verified direct and indirect head acceleration events measured in practice over the entire season.
Number of practice head impacts
时间窗: Month 3
Number of verified direct head impacts measured in practice over the entire season.
Practice head impact rate
时间窗: Month 3
Rate of verified direct head impacts per athlete per practice
Practice head acceleration even rate
时间窗: Month 3
Rate of verified direct and indirect head acceleration events per athlete per practice
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
Median linear 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 linear acceleration.
95th percentile linear 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 linear 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
- Acceptability of Intervention Measure (AIM) Values(up to 13 weeks)
- Number of practices the intervention was implemented as prescribed(up to 13 weeks)
- Feasibility of Intervention Measure (FIM) Values(up to 13 weeks)
- Average minutes per practice of live time(up to 13 weeks)