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临床试验/NCT02850926
NCT02850926已完成不适用

The Effectiveness of Soccer Headgear to Reduce Concussion in Adolescents

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 3,050 人开始时间: 2016年8月最近更新:
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
3,050
试验地点
2
主要终点
The number Sport Related Concussion injuries

研究概览

简要总结

This study will determine if protective soccer headgear reduces the incidence or severity of Sport Related Concussion injuries (SRCs) in US adolescent (high school) soccer players. Half the subjects will practice and play during their soccer season with soccer head gear specifically marketed to reduce the incidence of SRCs while the other half of the subjects will practice and play without the head gear.

详细描述

High school soccer is a very popular sport, with over one million male and female participants nationwide each year. Approximately 109,000 Sport Related Concussion SRCs were sustained by U.S. high school soccer players last year.

Despite the high incidence of SRCs in this population, little is known about the type of protective head gear that is being marketed to players and coaches to prevent SRCs. There are conflicting lab studies that show players may or may not be protected from sustaining a SRC while wearing head gear. However, there have been no large, prospective, randomized trials to examine the effect of soccer headgear on the incidence and severity of SRC in high school soccer players.

Approximately 3,000 high school soccer players (male and female, age 14-18, grades 9 - 12) from 88 United States high schools (44 per year) will be enrolled as subjects. All subjects will be asked to complete a short baseline survey regarding their previous history of SRCs. Schools will be randomly assigned to be in the head gear (intervention) group or no head gear (control) group. Subjects in schools assigned to the intervention group (n = 1500, 44 schools) will be asked to wear the protective soccer head gear provided by the study team for all practices and games throughout their high school soccer season. Subjects in the control group schools (n = 1500, 44 schools) will be allowed to practice and compete as they normally would (without head gear). Licensed athletic trainers (ATs) employed at each participating school will electronically record and report the characteristics of all SRCs that are sustained by the subjects as well as their athletic exposures to the study team.

At the conclusion of the data collection, the rate of SRCs will be estimated using Kaplan and Meier survival analysis and compared between the intervention and control group using a log-rank test. Cox Proportional Hazards modeling will be utilized to examine the relationship between SRCs and the independent variables (age, sex, competition level and previous SRC history). Wilcoxon Rank Sum tests will be used to determine if there was a significant difference in the injury severity between the intervention and control subjects. All analyses will control for school cluster effect and will be performed at the threshold of α = 0.05.

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
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • be a member on one (freshman, junior varsity or varsity) of the schools interscholastic soccer teams
  • be in grades 9 to 12,
  • be able to fully participate (no disabling injuries) in team activities on the day of pre-season team practices
  • athlete and parent (when appropriate) sign the mandated University of Wisconsin Research Informed Assent/Consent and HIPAA Research Forms.

排除标准

  • are not a member of the schools interscholastic soccer (freshman, junior varsity or varsity) teams,
  • are not in grades 9 to 12,
  • the athlete or parent (when appropriate) does not sign the mandated University of Wisconsin Research Informed Assent/Consent and HIPAA Research Forms.

研究组 & 干预措施

Soccer head gear

Experimental

Subjects who are wearing soccer head gear during the practices and games during the soccer season.

干预措施: Soccer head gear (Other)

Control

No Intervention

Subjects who are not wearing soccer head gear during the practices and games during the soccer season.

结局指标

主要结局

The number Sport Related Concussion injuries

时间窗: 2 years

To determine if the number of SRC injuries in soccer players wearing HG is lower than soccer players who did not wear head gear (NoHG).

次要结局

  • Number of days of soccer participation lost due to Sport Related Concussion injuries(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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