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临床试验/NCT05343052
NCT05343052已完成不适用

Hamstring Injury (HAMIR) Index: A Framework for Injury Mitigations Strategies Through Innovative Imaging, Biomechanics, and Data Analytics

University of Wisconsin, Madison5 个研究点 分布在 1 个国家目标入组 699 人开始时间: 2022年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
699
试验地点
5
主要终点
Aim 1: Initial Hamstring Strain Injury (HSI)

研究概览

简要总结

The investigators will combine state-of-the-art quantitative imaging, on-field biomechanics, and computational analytics into the largest-of-its-kind study to assess hamstring strain injury (HSI) risk and recovery in elite collegiate football players. The study will take place over 3 years and enroll up to 560 student athletes from Division I (D1) teams: University of Wisconsin-Madison, Brigham Young University and the University of North Carolina-Chapel Hill.

详细描述

The current approach to assess hamstring strain injury (HSI) risk and recovery is suboptimal. Many player-games are lost in American Football due to the lack of a clear understanding of the risk factors for HSI and the absence of effective methods to minimize re-injury.

The investigators propose that the key issues are: 1) every athlete is unique; therefore, a "one-size-fits-all" approach to HSI risk assessment will not work; 2) clinicians have limited relevant information on the potential injury risk for a specific athlete; 3) current methods to assess the extent of injury in a specific athlete are largely qualitative, limiting the ability to determine re-injury risk; and 4) current use of biologic injections is common, yet studies to quantify their effects are lacking. In this study, the investigators will address these four critical barriers by combining state-of-the-art quantitative imaging, on-field biomechanics, and computational analytics into the largest-of-its-kind study of elite collegiate football players.

The study will be conducted in 4 Division I collegiate men's football teams over a 3-year period. All student-athletes enrolled in this study will complete preseason hamstring strength testing, inertial measurement units (IMU)-based sprinting biomechanics, and undergo baseline magnetic resonance imaging (MRI). Student-athletes will be monitored by athletic trainers throughout the school year, who will record injuries and participation (e.g., time in practice, game).

Student-athletes who sustain an HSI will undergo a clinical assessment at the time of injury along with an MRI examination. Following completion of a rehabilitation program, hamstring strength will be re-evaluated and imaging will be repeated, along with performance measurements.

This study will provide the most detailed understanding of the physiological causes and effects of HSI, advancing our understanding of the processes affecting muscle function and improving our ability to evaluate, treat, and prevent HSI. This study represents what will be the largest, most quantitative prospective cohort study ever into HSI. Data gathered as part of this study will be used to develop a quantitative Hamstring Injury (HAMIR) index such that the medical and scientific communities can identify an individual athlete's propensity for HSI, and, more importantly, identify targets for injury mitigation, thereby reducing the global burden of HSI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Student-athlete rostered on the varsity football team of participating institutions between 5/1/2022-6/30/2025 (study period)

排除标准

  • •History of malignant disease
  • •Contraindication to MRI

结局指标

主要结局

Aim 1: Initial Hamstring Strain Injury (HSI)

时间窗: up to 3 years

The outcome will be occurrence of an index HSI, measured at the athlete level. Athlete characteristics will be used to develop the quantitative HAMIR index to predict those at greatest risk of HSI. This aim will also identify potential future targets for injury risk mitigation and prophylactic strategies. HSI defined as an acute injury to the posterior thigh that limits full, unrestricted sports participation and includes two or more of the following symptoms: palpable pain along the hamstring muscles, posterior thigh pain without radicular symptoms, weakness and/or pain with resisted knee flexion, and pain with running.

Aim 2: Recurrent Hamstring Strain Injury (HSI)

时间窗: up to 3 years

The outcome will be the occurrence of a recurrent, or secondary, HSI measured at the athlete level. The investigators will use quantification of injury metrics (e.g., volume of initial edema and volume, shape and location of long-term scar) and incorporate these into the analytics framework to develop a new "re-injury" HAMIR index. Similar to Aim 1, this aim will identify potential future targets for re-injury risk mitigation and prophylactic approaches. Re-injury will be defined as an acute HSI that occurs to either limb within 6 months of an index HSI.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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