可变摩擦鞋的表征和临床试验
2026年5月7日 更新者：Arun Jayaraman, PT, PhD、Shirley Ryan AbilityLab
可变摩擦鞋的特性和临床试验，一种针对中风引起的足下垂患者的减少约束运动治疗的新范例
超过一百万美国人中风后出现足下垂。
随着美国和世界各地人口老龄化的增长，中风的发病率将会增加，因为年龄是一个关键的危险因素，因此需要低成本、易于使用和可扩展的解决方案来进行适当的管理治疗以促进康复。
本研究将评估可变摩擦鞋（VF 鞋），这是一种新型低成本医疗设备，用于在家中治疗足下垂。
研究概览
详细说明
我们提出了一种替代策略，即使在允许完全自主控制脚踝的情况下也可以解决绊倒的危险：一种廉价的可变摩擦（VF）鞋。 其外底在步态站立阶段具有高摩擦力，在摆动过程中具有低摩擦力；此外，当发生磨损时，它会产生“咔哒”声。
我们的中心假设是，允许脚踝自主运动，同时减轻绊倒的危险，再加上步态阶段的听觉生物反馈，将改善足下垂受试者的步态。 具体来说，我们假设 VF 鞋将显示出比 AFO 显着更好的治疗效果，同时保持 AFO 所需的矫形效果。 我们将工作安排在两个目标中。
具体目标 1：表征 VF 鞋在使用寿命期间磨损力的减少情况。 了解 VF 鞋的效果的关键是表征磨损力减少的水平。
具体目标 2：评估 VF 鞋对慢性中风和足下垂患者步态的影响。 在 AB-BA 临床试验的每个 12 周阶段，参与者每天至少步行 30-45 分钟，每周至少 5 天在家步行。
研究类型
介入性
注册 (估计的)
50
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。
学习联系方式
- 姓名：Joe Harris, DPT
- 电话号码：312-238-8425
- 邮箱：jharris2@sralab.org
研究联系人备份
- 姓名：Jennifer Bartloff, DPT, PhD
- 电话号码：312-238-1562
- 邮箱：jbartloff@sralab.org
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- 招聘中
- Shirley Ryan Abilitylab
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接触：
- Sara Prokup, DPT
- 电话号码：3122381355
- 邮箱：sprokup@sralab.org
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接触：
- Joe H PT, DPT
- 电话号码：312-238-8425
- 邮箱：jharris2@sralab.org
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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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 中风后 3 个月 - 1 年（患者通常需要安装足下垂装置的时期）
- 18 岁或以上
- 拥有指定的 AFO 或成为使用 AFO 的潜在候选人
- 无论有或没有拐杖或助行器等辅助器具，均可行走至少 10m
- 由医生体检确定健康状况稳定
- 至少 3 个月内预计不会改变药物治疗
- 站立时脚踝有足够的稳定性
- 能够听到 VF 鞋发出的咔嗒声
- 医生批准
- 给予知情同意的能力
- 能够在没有支撑的情况下坐下并能够遵循三步命令
- 上肢或下肢没有未愈合/未解决的骨科损伤，并且没有严重背痛史
- 英语会话
- 愿意使用两种设备执行锻炼计划，每天至少 30 分钟，每周至少 5 天，完成整个计划（6 个月）
排除标准：
- 中风前每周跌倒超过一次的病史
- 步态速度：自选速度（SSV）大于1.2 m/s
- 无法安全操作设备且没有护理人员协助
- 病态肥胖（体重指数>40 kg/m2）
- 现有疾病，如严重心脏病、心肌梗塞、充血性心力衰竭、需要起搏器、癫痫发作、过度感觉异常疼痛以及严重的下肢病变，这些都会影响鞋子的合脚或使用。
- 认知或沟通严重缺陷
- 孕妇（状况由自我报告确定）。
- 干扰研究的合并症（例如 严重的关节炎或关节问题、背部受伤史、神经肌肉疾病、癫痫等）。
- 严重骨质疏松症（由自我报告确定的状态）。
- 囚犯
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：AB 臂：可变摩擦鞋训练、AFO 训练
基线 (T0)、12 周可变摩擦鞋训练、随访 (T1)、2 周冲洗、随访 (T2)、12 周 AFO 训练、随访 (T3)
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实验组（A）将获得一双VF鞋，并指示双脚都穿鞋。
该小组将被指示在坚硬的表面上行走，以获取 VF 鞋的听觉反馈。
该小组将每天使用体动记录仪进行监测，并且每周都会接到研究团队成员的检查电话，以记录步数、行走时间、自我认定的努力量表和感知的安全水平。
对照组 (B) 将获得一个 AFO 用于瘫痪肢体。
该小组将被指示在坚硬的表面上行走。
该小组将每天使用体动记录仪进行监测，并且每周都会接到研究团队成员的检查电话，以记录步数、行走时间、自我认定的努力量表和感知的安全水平。
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实验性的：手臂 BA：踝足矫形器 (AFO) 训练、可变摩擦鞋训练
基线 (T0)、12 周 AFO 训练、随访 (T1)、2 周冲洗、随访 (T2)、12 周可变摩擦鞋训练、随访 (T3)
|
实验组（A）将获得一双VF鞋，并指示双脚都穿鞋。
该小组将被指示在坚硬的表面上行走，以获取 VF 鞋的听觉反馈。
该小组将每天使用体动记录仪进行监测，并且每周都会接到研究团队成员的检查电话，以记录步数、行走时间、自我认定的努力量表和感知的安全水平。
对照组 (B) 将获得一个 AFO 用于瘫痪肢体。
该小组将被指示在坚硬的表面上行走。
该小组将每天使用体动记录仪进行监测，并且每周都会接到研究团队成员的检查电话，以记录步数、行走时间、自我认定的努力量表和感知的安全水平。
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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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步行速度（设备关闭）
大体时间：26周
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10米步行测试（米/秒）
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26周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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伯格平衡量表
大体时间：26周
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14 项客观测量，旨在评估成年人群的静态平衡和跌倒风险。
评估的项目包括转移过程中的选址和站立平衡、改变支撑基础、伸手、转身、睁眼和闭眼。
每项评分为 0 至 4 分，最高分为 56 分。
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26周
|
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6 分钟步行测试
大体时间：26周
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6MWT 测量受试者在 6 分钟内（必要时使用辅助设备）在室内平坦、坚硬的表面上行走的距离。
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26周
|
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中风影响量表
大体时间：26周
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SIS 是衡量中风对整体身体和认知功能影响的有效指标。
这项基于患者的 59 项问卷评估了中风恢复的八个领域：力量、活动能力、沟通、情绪、记忆和思维、参与、日常生活活动/日常生活工具活动 (ADL/IADL) 和手功能。
另一个问题要求患者按照 0 到 100 的等级对中风恢复情况进行评分。
该措施指示受试者根据问卷调查前两周四个星期的时间段回答问题
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26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。
合作者
调查人员
- 首席研究员：Arun H Jayaraman, DPT, PhD、Shirley Ryan Abilitylab
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)
2024年4月3日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2024年1月22日
首先提交符合 QC 标准的
2024年1月22日
首次发布 (实际的)
2024年1月31日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月7日
最后验证
2026年5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.