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临床试验/NCT04810130
NCT04810130已完成不适用

Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年12月15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
27
试验地点
2
主要终点
Change in Clinical Concussion Exam immediately post intervention

研究概览

简要总结

There is growing concern for the resulting neurological and physiological outcomes from repeated head impacts in sports that do not manifest into traditional concussion symptoms. Specifically, there is evidence of immediate physiological deficits following controlled soccer heading. This study will compare the physiological changes of adolescents completing a set of soccer headers to those randomized to a set of soccer kicks to evaluate the effect of repetitive head impacts.

详细描述

There is limited data relating head impact biomechanics to neurological outcomes in humans. Concussion occurs from rotational loading of the head giving rise to diffuse stresses and strains in the brain tissue leading to autonomic and physiological dysfunction. Repeated head loading is common in contact sports and an integral part of soccer. It is unknown whether the same biomechanical forces from lower severity head impacts such as typical soccer heading cause temporary physiological deficits as well. Advancement of objective physiological function assessment devices allow measurement of neurological effects in the absence of diagnosed concussion. Recent soccer heading studies have evaluated neurophysiological changes pre- and post-repetitive heading. These studies have found conflicting results for the effect on neurocognitive performance immediately following a bout of heading, but consistent changes were observed in measures of vestibular balance, ocular function, and neurochemical biomarkers.

Soccer heading biomechanics studies showed that females experienced higher severity head loading, and in equivalent sports such as soccer and basketball, females have higher concussion rates. This study will compare the physiological changes of male and female adolescents completing one of two soccer heading paradigms to those randomized to kicking to evaluate the effect of repetitive head impacts. This study will relate biomechanical measures of head loading with physiological function changes associated with repeated head impacts, and compare sex-differences in biomechanical measures and physiological changes.

研究设计

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

入排标准

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

入选标准

  • Males or females ages 13 to
  • Actively participating on a competitive soccer team.
  • At least 1 year of soccer heading experience.
  • Parental/guardian permission (informed consent) and child assent.

排除标准

  • Subject sustained a concussion or spinal injury within the past 6 months or still has active symptoms from a previous injury.
  • Inability to exercise because of lower-extremity orthopedic injury or significant vestibular or visual dysfunction.
  • Currently taking medications that can affect autonomic function.
  • Plays exclusively the goalkeeper position and does not regularly head the ball.
  • Parental/guardian permission (informed consent) not obtainable or not provided.
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
  • Subject has fixed orthodontia on upper teeth.
  • Cannot understand English.

结局指标

主要结局

Change in Clinical Concussion Exam immediately post intervention

时间窗: Pre-intervention to 0 hours post intervention

A standard concussion physical exam includes smooth pursuits, horizontal and vertical saccades, horizontal and vertical gaze stability, visual motion sensitivity, convergence and divergence, and tandem walk.

次要结局

  • Head angular velocity(During Intervention)
  • Change in Clinical Concussion Exam at up to 72 hours post intervention(Pre-intervention to between 16 and 72 hours post intervention)
  • Head linear acceleration(During Intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Physiological Effects of Soccer Heading | 临床试验