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临床试验/NCT04919707
NCT04919707已完成不适用

Evaluation of Head Kinematics, Force-strain Models, and Correlation of MRI Markers With Neurocognitive Testing in Youth Soccer Heading

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Force Strain Kinematic Model Development: Minimum Principle Strain

研究概览

简要总结

This study aims to establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months.

详细描述

Despite the large popularity of soccer worldwide and in the US, the majority of research on sport-related head impacts has been concentrated in male American football players using head-impact measurement sensors in instrumented football helmets. The limited research in soccer players likewise has focused on males, particularly those playing at an elite level, such as collegiate or professional. Unfortunately there is a paucity of data on youth soccer athletes in regards to how these younger players actually head the ball and what forces they experience. Measurement of head impacts is essential to further understanding the potential risks associated with heading in youth soccer, and to further inform rule or policy changes that limit head impact exposure in these younger age groups.

Specific Aim: Establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks.

In this study, age-and sex-specific force strain models will be validated using a study of soccer headers under controlled conditions. Youth soccer players in 6th-12th grade will be recruited to participate in a header training session while wearing motion sensor headbands. All children will undergo MRI scanning and baseline assessment of neurocognitive function, psychological health, and academic aptitude and performance. Participant-specific finite element models will be created from MRI scans, and principle tissue strains will be determined based on head motion profiles during soccer headers and compared between age- and sex-specific groups.

High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. MRI scans will be obtained in all participants, and individualized and population averaged (to reduce computational burden), whole brain tractographs will be created. New participants-specific finite element models will be generated using geometry-adaptive mesh morphing techniques to match the head morphology of each subject using a baseline FE head model (to reduce model development time). The linear and angular acceleration histories obtained from the pre- and post-training soccer heading tasks will be applied directly to the FE models to simulate the head motion of each participant. The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session. This analysis will provide insight into the effect of age and training on improving heading techniques and reducing the risk of injury.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Age 12-13 or 16-18 years
  • •Currently participating in organized interscholastic or club soccer
  • •No active musculoskeletal injury that limits full participation in soccer activities

排除标准

  • •14-15 year old are not eligible
  • •History of prior concussion or other head injury
  • •History of prior cervical spine injury
  • •Potential participants who can not participate in the MRI scan will be excluded
  • •Pregnancy or possible pregnancy (one reason for MRI exclusion)

研究组 & 干预措施

Older Adolescent Soccer Players

Experimental

10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI

干预措施: Header Session (Behavioral)

Older Adolescent Soccer Players

Experimental

10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI

干预措施: MRI Session (Procedure)

Younger Adolescent Soccer Players

Experimental

10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI

干预措施: Header Session (Behavioral)

Younger Adolescent Soccer Players

Experimental

10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI

干预措施: MRI Session (Procedure)

结局指标

主要结局

Force Strain Kinematic Model Development: Minimum Principle Strain

时间窗: up to 2 months

High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.

Force Strain Kinematic Model Development: Maximum Strain

时间窗: up to 2 months

High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.

Force Strain Kinematic Model Development: Maximum Axonal Strain

时间窗: up to 2 months

High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.

Whole brain tractography (fiber tracking) created by MRI scans

时间窗: up to 2 months

Whole brain tractographs will be created from MRI scans using Diffusion Tensor Imaging.

Brain Injury Probability Map Development: Change in Tissue Strain

时间窗: During the header task session, up to 2 months

The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk.

次要结局

  • BRIEF-Monitoring Trail Making Parts A and B Score(up to 2 months)
  • Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score(up to 2 months)
  • Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms(up to 2 months)
  • Patient Health Questionnaire (PHQ-9) Score(up to 2 months)
  • General Anxiety Disorder Scale-7 (GAD-7) Score(up to 2 months)
  • Pediatric Quality of Life Inventory (PEDS-QL) Score(up to 2 months)
  • Deep Cervical Flexor Endurance Test (DCFET)(up to 2 months)
  • Y Balance Test (YBT)(up to 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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