一项调查踝关节康复计划对踝关节不稳高中运动员影响的研究
2018年10月12日 更新者：Mary Spencer Cain、Georgia State University
一项随机对照试验，调查为期 4 周的踝关节康复计划对患有慢性踝关节不稳的高中运动员的影响
一项随机对照试验，调查为期 4 周的踝关节康复计划对患有慢性踝关节不稳的高中运动员的影响。
研究概览
详细说明
一项随机对照试验，调查三种不同的为期 4 周的踝关节康复计划对患有慢性踝关节不稳的高中运动员的影响。
我们将使用问卷来评估主观功能水平和临床措施，以通过静态和功能平衡来评估临床功能。
研究类型
介入性
注册 (实际的)
43
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Georgia
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Atlanta、Georgia、美国、30327
- Holy Innocents' Episcopal School
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Atlanta、Georgia、美国、30327
- The Lovett School
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Atlanta、Georgia、美国、30327
- The Westminister Schools
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College Park、Georgia、美国、30337
- Woodward Academy
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Decatur、Georgia、美国、30030
- Decatur High School
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Marietta、Georgia、美国、30062
- The Walker School
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Marietta、Georgia、美国、30062
- Walton High School
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 每周活动至少 1.5 小时，至少有 1 次需要医疗干预的严重脚踝扭伤病史，反复出现疼痛、肿胀、虚弱、不稳定和反复发作的“屈服”症状。
排除标准：
- 存在任何当前下肢损伤（在过去 3 个月内由医疗专业人员诊断并出现症状），之前对任何一条腿进行过手术，在过去 6 周内诊断为脚踝扭伤，脚踝骨折和/或脱臼的历史。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：控制组
对照组中的每名患者均不进行任何康复锻炼。
在干预时间范围内，患者需要每周与研究团队的一名成员一起检查，讨论他们脚踝的任何变化或报告任何伤害发生率。
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实验性的：阻力带组
每个疗程，患者使用阻力带在 4 个踝关节运动方向（跖屈、背屈、内翻和外翻）完成阻力训练。
患者将在每个疗程期间完成 3 组，每组 10 次重复。
每 3 个疗程，阻力带会增加。
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阻力带 - 使用张力带在脚踝运动期间提供阻力
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实验性的：生物力学踝平台系统
生物力学踝关节平台系统板是一种椭圆形板，利用板底部的半球体使患者能够在不稳定的表面上进行训练。
在完成顺时针和逆时针圆圈的同时，在生物力学踝关节平台系统板上对受累肢体进行单腿站立。
初始旋转方向由患者选择，并在 40 秒试验中每 10 秒改变一次。
完成了五次 40 秒的试验，试验之间有 1 分钟的休息间隔。
进展由监督临床医生确定，并基于患者在方向变化和完成两个方向的平滑圆周旋转之间进行平滑过渡的能力。
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生物力学踝关节平台系统板组 - 使用不同水平的半球体来增加脚踝处允许的运动量。
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实验性的：组合组
完成组合方案的患者在每个疗程期间完成了阻力带和生物力学踝关节平台系统板方案。
每个会话的练习完成顺序是平衡的。
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组合组 - 包括阻力带和生物力学踝关节平台系统程序。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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静态平衡评估
大体时间：4周
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静态平衡临床测试
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4周
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功能平衡评估
大体时间：4周
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功能平衡临床测试
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4周
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患者自我报告的结果
大体时间：4 至 12 周
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主观患者报告结果问卷
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4 至 12 周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Benjamin M Goerger, PhD、Georgia State University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月14日
初级完成 (实际的)
2018年8月13日
研究完成 (实际的)
2018年8月30日
研究注册日期
首次提交
2018年1月28日
首先提交符合 QC 标准的
2018年2月26日
首次发布 (实际的)
2018年2月27日
研究记录更新
最后更新发布 (实际的)
2018年10月15日
上次提交的符合 QC 标准的更新
2018年10月12日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.