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临床试验/NCT03237468
NCT03237468Unknown不适用

Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes

CentraCare2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年8月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
CentraCare
入组人数
1,500
试验地点
2
主要终点
Effect of increase in neck strength in reducing risk of concussion

研究概览

简要总结

Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.

详细描述

After recruitment, subjects will have neck strength measured as baseline in addition to doing SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment for concussion. Throughout study, subject will perform basic, unweighted and weighted neck strengthening exercises twice a week. Periodic re evaluations of neck strength will be performed in order to determine progress. Any time a subject incurs a sports related concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared to baseline to measure severity of injury. Weekly follow ups will be done to assess duration of concussion. All measurements, assessments, and exercises are non-invasive and provide minimal risk to subjects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.
  • Written informed consent obtained by the subject or subject's legal guardian.
  • Written assent from subjects ages 8 years old and above
  • Subject is between the ages of 5 and 22 years, male or female.
  • Subjects from all racial and ethnic origins will have an opportunity to participate.

排除标准

  • Corrected vision less than 20/500.

结局指标

主要结局

Effect of increase in neck strength in reducing risk of concussion

时间窗: One year

Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.

次要结局

  • Effect of baseline neck strength on risk of concussion(One year)

研究者

发起方
CentraCare
申办方类型
Other
责任方
Sponsor

研究点 (2)

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