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临床试验/NCT03304327
NCT03304327已完成不适用

Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)

Duke University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.

研究概览

简要总结

The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in the post-concussion period.

详细描述

Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians evaluating sports concussion at the SSI. Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team in a stamped envelope. We expect to enroll 20 subjects.

If a subject has significant worsening of their symptoms and wishes to discontinue the study, they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr. Morgenlander will document the specific reasons for discontinuation of the protocol. All follow-up care for their concussion will be through the provider they are already seeing for concussion. There is no significant risk to the athlete for participation except possible transient increase in their concussion symptoms. Benefits include possible hastening of recovery from their concussive symptoms and receiving training in mindfulness and yoga from a certified yoga instructor.

研究设计

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

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Injury sustained within 30 days of enrollment
  • Being seen for concussion at the Sports Science Institute (SSI) at Duke University Medical Center
  • living in a 30 mile radius of the SSI
  • SCAT5 (Sport Concussion Assessment Tool 5) modified symptom checklist score of greater than 12

排除标准

  • 未提供

结局指标

主要结局

Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.

时间窗: up to 7 days

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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