步态再训练对下肢生物力学的影响
步态修正策略对膝关节内侧骨性关节炎患者膝关节内收力矩影响的比较:随机对照试验
这项拟议研究的目的是调查步态再训练后额面膝力矩的急性和慢性反应,并评估对侧生物力学的影响。 将招募 51 名诊断为胫股关节骨关节炎 (TFJ OA) 的患者参与拟议的研究。 参与者将完成基线试验以评估步态运动学和动力学参数。 在基线之后,每个参与者将执行足部前进步态的六个条件或躯干倾斜步态修改的三个条件,以确定哪种策略在减少正面膝力矩方面最有效。 然后,参与者将根据他们确定的首选策略随机分配到对照组或实验组。
参与者将在训练期间使用针对患者的步态修改(量身定制的足部进步和量身定制的横向躯干倾斜)或正常步态(控制)完成八次步态再训练课程。 将实施衰落反馈设计。 前两周的每一步都会提供实时触觉生物反馈,随后每两周减少 25%。 在基线和测试期间将不会提供任何反馈。 还将在所有测试阶段收集疼痛和功能测量值。 感兴趣的变量包括踝关节、膝关节、髋关节矢状面和额状面力矩。 此外,还将评估矢状面和额状面脉冲。
将计算足部前进角度、躯干倾斜角度、额状面和矢状面髋、膝和踝角度以及力矩的描述性统计数据。 还将计算额面膝脉冲的描述性统计数据。 将进行多变量方差分析 (MANOVA) 以比较额状面膝关节力矩、额状面膝关节冲动和绝对矢状面力矩,将在四个不同时间点跨三组进行比较。 将进行重复测量方差分析 (ANOVA) 以比较对侧肢体的矢状面和额状面关节生物力学。 p 值将设置为 0.05。
研究概览
详细说明
将使用带有候补名单的随机对照研究设计来研究为期 10 周的步态再训练干预对膝关节内收力矩的影响。 参与者将被随机分配到干预组或对照组。 干预组将进一步分为两组。 一组将由通过改变足部前进步态减少膝关节内收力矩 (KAM) 最多的参与者组成,另一组将由在预评估期间通过躯干倾斜步态最有效地减少 KAM 的参与者组成。 然后,参与者将使用其特定的步态修改策略(干预)或正常步态(控制)在 8 周内(每周一次)进行 8 次步态再训练。 作为候补名单设计的一部分,在 10 周结束时,分配到对照组的患者将被重新分配到他们之前确定的患者特定步态修改干预。 目标是尽量减少人员流失并增加有效样本量。
到达实验室后,参与者将被要求阅读并签署知情同意书。 将记录参与者的身高和体重。 疼痛和功能将使用西安大略和麦克马斯特大学关节炎 (WOMAC) 问卷和从 0 到 10 的数字评定量表 (NRS) 进行评估,其中 0 代表没有疼痛,10 代表疼痛程度最高。 出于本研究的目的,实验肢体被定义为诊断为有症状的 TFJ OA 的腿或双侧 OA 中症状最严重的肢体。 参与者将配备 4 个表面肌电图 (sEMG),放置在实验肢体的股直肌、股内侧肌、股二头肌和半腱肌上。 EMG 传感器将用于记录基线测试期间的肌肉活动。 然后参与者将在他们的躯干和下肢上贴上 53 个反光标记。 通过让参与者站在最前面的测力板上,双脚与实验室的前后轴对齐,将获得 VICON 运动捕捉系统的静态校准试验。 参与者还将通过完成髋关节的三个顺时针旋转来执行动态校准,这将用于估计髋关节中心。 然后,参与者将以他们喜欢的速度完成 5 项基线步行试验以及 6 米的人行道。 参与者将被要求在跑步机上步行 12 分钟,并将记录其他数据。 然后,参与者将被要求执行 9 种条件,改变足部前进步态或躯干倾斜步态,以确定哪种策略对减少 KAM 最有效。 参与者将首先收到关于如何实现指示的步态修改的标准化口头说明。 然后将为参与者提供触觉实时生物反馈,以确保他们成功实现所需的步态修改幅度。 在 Vicon 中收集的运动学数据将传输到 Matlab(Mathworks,Natick,MA)以实时计算关节角度。 参与者将收到触觉传感器的反馈,这些传感器连接到腓骨的外侧近端(足部进展)或实验侧的肩胛骨中心(侧躯干倾斜),带有低过敏性双面胶带。 一次振动表示目标步态参数需要减少,而两次振动表示需要增加。 每一步都将提供反馈,没有振动将表明不需要更正。 只有当参与者用实验肢体的脚完全接触力板两次并且修改后的参数在规定的目标范围内时,试验才会被视为有效。 此外,参与者将需要保持相对于基线的平均步态速度 ±5%,才能将试验视为成功。 在基线会话中完成的修改将随机分配给每个参与者。 这些试验完成后,参与者将在同一周内返回实验室,完成 5 个额外的基线试验和 3 个他们在第一天没有进行的步态修改试验。 每个基线数据收集会话大约需要一个小时。
然后参与者将被随机分配到干预组或对照组。 干预组将进一步分为两组。 一组将由通过改变足部前进步态减少 KAM 最多的参与者组成,另一组将由通过躯干倾斜步态最有效地减少 KAM 的参与者组成。 然后,参与者将使用其特定的步态修改策略(干预)或正常步态(控制)在 8 周内(每周一次)进行 8 次步态再训练。 在步态再训练期间,参与者将在位于校准体积区域(约 0.5 x 1.5 米)中心的 Woodway Desmo 跑步机(Woodway,Waukesha,WI)上行走。 将使用以 200 Hz 采样的三摄像头高速运动分析系统(Vicon,Oxford,England)来记录步态运动学。 指示的解剖学标志(C7 和 T10 或跟骨后部和第二跖趾关节)将用紫外线笔标记,这将允许一周的可见度,并将在随后的访问中重新应用。 这将提高步态再训练阶段标记放置的可重复性。 在每次步态再训练课程开始之前,将提供五分钟的动态热身;然后,参与者将按照他们的个性化步态修改策略步行 20 分钟。 将以个性化阶段概述的相同方式向参与者提供触觉反馈,或者将在没有反馈的情况下继续行走。 将跨会话实施渐变反馈设计,以逐步整合任务获取和转移,并帮助促进所学技能的内化。 在前 2 周内,每一步都会提供实时生物反馈 (RTB)。 对于第三周和第四周,RTB 将在实验腿的前 3 次足击中提供,并在第四周停止提供,表示减少 25%。 在第五周和第六周,将提供关于交替脚部撞击的反馈,将 RTB 频率交付减少到 50%。 在最后两周的步态再训练中,前三个步骤不会提供反馈,但会在第四个步骤中提供反馈,将 RTB 频率降低到 25%。
在步态再训练课程之间,受试者将被指导在实验室课程之外自行练习他们获得的步态策略,这将在没有反馈的情况下发生。 他们将被指导每天至少练习 10 分钟,并将每周提供活动日志以记录步态再训练八周期间每天的时间和练习量。 练习日志将每周提交。 在干预过程中,将在第 4 周(第一次测试后)和第 9 周(第二次测试后)进行地面步态分析和 12 分钟的跑步机步行,以跟踪技能习得。 此测试将与基线试验相同,但是,将指导参与者仅使用其特定的步态修改策略行走。 在任何技能获取或保留测试期间都不会提供任何反馈。 后续测试将在干预后 1、3、6 个月和一年进行,以衡量对规定步态修改的保留情况。
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Oladipo Eddo
- 电话号码:7039937183
- 邮箱:oeddo@gmu.edu
学习地点
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Virginia
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Manassas、Virginia、美国、20110
- 招聘中
- Sports Medicine, Assessment, Research & Testing (SMART) Laboratory
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接触:
- Oladipo Eddo, PhD
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首席研究员:
- Oladipo Eddo, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 由合格的健康专家(如整形外科医生或物理治疗师)对膝骨关节炎进行的临床诊断
- 18至80岁之间
- 能够独立行走至少 20 分钟
排除标准:
- 体重指数大于 35
- 过去 2 年内腰部、髋部或膝部手术史
- 膝关节镜检查或药物注射在过去六个月
- 影响行走的神经或肌肉骨骼疾病
- 会抑制运动学习的认知障碍
- 使用步态辅助器、矫形鞋垫或铰链护膝
学习计划
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:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:控制
无干预
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实验性的:足部进展
参与者将实时可视化所需的脚部前进角度带宽,他们应该以脚部角度为目标
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干预将是步态再训练生物反馈,重点是步态试验期间的足部角度
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实验性的:躯干倾斜
参与者将实时可视化所需的躯干倾斜角度带宽,他们应该以躯干倾斜角度为目标
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干预将是步态再训练生物反馈,重点是步态试验期间的躯干倾斜角度
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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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与基线相比的变化 10 周时膝关节内收力矩与基线相比的变化
大体时间:将在基线和 10 周步态再训练干预时使用生物力学分析对其进行评估
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膝内收力矩是评估膝关节负荷的替代指标。
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将在基线和 10 周步态再训练干预时使用生物力学分析对其进行评估
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合作者和调查者
调查人员
- 首席研究员:Nelson Cortes、Associate Professor
出版物和有用的链接
一般刊物
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膝骨性关节炎的临床试验
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The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang Hospital尚未招聘膝关节骨性关节炎 (Knee OA)
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Universitas SriwijayaPT Bifarma Adiluhung尚未招聘
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First Affiliated Hospital of Wenzhou Medical University尚未招聘
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Ankara Etlik City Hospital主动,不招人
足部进阶的临床试验
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Indiana UniversityUnited States Department of Defense; University of Notre Dame完全的
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Intergruppo Melanoma Italiano主动,不招人