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可调节假肢接受腔

2026年7月16日 更新者：VA Office of Research and Development

适用于下肢截肢退伍军人的可调节接受腔：患者报告结果与接受腔内压力

每年，约有1500名退伍军人加入美国623,000名下肢截肢者的行列。 这些退伍军人中，许多人选择艰难的康复之路以保持行走能力，这一过程包括开具下肢假肢处方。 假肢的适配性至关重要。 适配良好的假肢感觉舒适，并能支持多种行走活动。 适配不佳则会导致不适，常伴随慢性皮肤问题，日常活动能力也会受限。

传统假肢接受腔由熟练的假肢师定制，精心塑形以贴合退伍军人的残肢，通常能实现良好适配。 这些接受腔是刚性、固定形状的结构，具有推土机般的坚固性，专为持续、高强度活动而设计。 遗憾的是，个体残肢的形状可能随时间变化，导致良好适配最终变差。 据估计，每三年半就需要一个新的膝下接受腔。 更换不再适配的接受腔费用不菲。 2017年，医疗保险（Medicare）用于更换现有膝下接受腔及相关组件的支出估计为5000万美元。 重要的是，医疗保险估计仅占市场的20%，这表明整个下肢截肢人群的估计支出可能显著更高。 一种能长期保持适配性的良好假肢将对退伍军人大有裨益。

可调式假肢接受腔是一种潜在解决方案，可使良好适配更持久。 尽管支持其处方实践的证据有限，但医疗保险和医疗补助服务中心（CMS）最近批准了对可调式假肢接受腔的报销，这表明对此类产品存在迫切需求。

为研究潜在有害影响及退伍军人如何使用可调式假肢接受腔，本研究旨在确定在不同强度活动期间，可调式假肢接受腔施加于残肢的压力，以及诱发调整的活动类型。

将进行一项基于实验室的人体实验，使用置于研究提供的可调式假肢接受腔可调面板内的定制传感器。 参与者将在实地适应可调式假肢接受腔两周，然后返回实验室进行七项活动。 在这些活动期间，将测量假肢内部压力。 参与者还将报告每项活动后其接受腔的紧束感。

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

使下肢截肢退伍军人能够进行行走活动的假肢接受腔，通常是刚性的、强度过大的固定形状结构元件，充当身体与环境之间的接口。退伍军人的假肢接受腔是定制的；它只适合一个人，且仅限一人。

提供假肢后，适配性发生变化的情况较为常见。与体重、肌肉萎缩或个人健康状况相关的变化可能在数月内发生，而由于饮食或糖尿病并发症引起的变化可能在数小时内发生。如果残肢与接受腔之间的形状差异较小，退伍军人可以通过穿脱残肢袜来应对这种差异。这种方法并不理想，因为一些患者比其他人更倾向于采用这种做法。如果形状差异较大，通常需要一个新的假肢接受腔。无论差异大小，未能有效管理这些变化都可能对其使用假肢和残肢健康产生负面影响。

尽管存在局限性，固定形状的假肢接受腔数十年来一直是标准护理。然而，2024年4月发生了一个可能具有重要意义的事件，当时美国医疗保险和医疗补助服务中心（CMS）批准了对可调节假肢接受腔的报销。虽然新的授权允许为其提供支付，但几乎没有证据帮助患者、提供者和支付者了解开具可调节假肢接受腔处方可能带来的结果。

本研究旨在通过测量在不同强度活动期间可调节假肢接受腔施加在残肢上的压力，发现退伍军人如何使用可调节假肢接受腔，并确定哪些活动可能引发调整。研究人员将招募具有单侧胫骨截肢的行走能力退伍军人（n = 25），并为他们配备可调节假肢接受腔。

参与者在佩戴非仪器化的复制可调节假肢接受腔两周后，将佩戴仪器化的可调节假肢接受腔。参与者将被允许行走5到10分钟，同时研究假肢师检查研究假肢的适配性和对齐情况。然后将在坐姿、站立和行走期间收集压力测量数据。站立和行走活动将按随机顺序进行，中间穿插1分钟的坐姿休息，期间参与者将释放可调节面板的压力。行走试验将在跑步机上进行。

  • 坐姿休息 5分钟

  • 随机顺序，每次活动之间穿插1分钟坐姿休息：

    • 站立 1分钟
    • 以自选速度行走 1分钟
    • 以自选速度在10%坡度上行走 1分钟
    • 以自选速度在10%坡度下行走 1分钟
    • 以比自选速度快15%的速度行走 1分钟
    • 以自选速度行走 10分钟 在每项活动开始前，参与者将被告知下一项活动是什么，并被提示相应调整其接受腔。参与者也可以在活动期间自由进行调整。在这种情况下，活动的持续时间将延长，以便在新的调整设置下保持1分钟的活动。在每项活动结束时，将通过调查问题评估紧密度。具体来说，在每项活动后，研究人员将要求每位参与者以0到10的评分标准，评估其可调节假肢接受腔在当时的紧密度。

总的来说，研究人员假设施加在残肢上的压力将取决于活动，紧密度也将如此。

研究类型

介入性

注册 (估计的)

25

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

学习地点

  • 美国
    • Washington
      • Seattle、Washington、美国、98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • 首席研究员：
          • Glenn K Klute, PhD
        • 接触：

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：

  • 下肢截肢的退伍军人
  • 单侧经胫骨截肢
  • 根据自我报告，每天佩戴假肢至少4小时
  • 截肢后至少一年
  • 拥有包含四螺栓接受腔连接的模块化假肢
  • 能够在跑步机上行走

排除标准：

  • 当前假肢的适配和悬吊不当，且通过临床资源无法实现良好适配
  • 当前残肢存在皮肤刺激或损伤、骨关节炎、损伤或疼痛，影响行走能力

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：可调节假肢接受腔
参与者将佩戴可调节的假肢接受腔。
设备：可调节式假肢接受腔
研究人员将为每位参与者制作并组装一个可调节的假肢接受腔，其形状与其现有、按处方配置的假肢接受腔完全相同。 我们将在假肢接受腔上增加三个可调节面板，这些面板将位于胫骨近端内侧和外侧区域以及腓肠肌后侧区域。 这些面板的位置将通过线缆机构进行内外调节。

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
Distal end pressure while seated (5 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
A pressure transducer will record the distal end residual limb pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while standing (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
A pressure transducer will record the distal end residual limb pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while walking at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking up 10% slope at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking down 10% slope at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking 15% faster than self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking at self-selected speed (10 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while seated (5 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while standing (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking up 10% slope at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking down 10% slope at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking 15% faster than self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (10 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.

次要结果测量

结果测量
措施说明
大体时间
Tightness while seated (5 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while standing (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking up 10% slope at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking down 10% slope at self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking 15% faster than self-selected speed (1 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (10 minute bout)
大体时间：After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.

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。

赞助

VA Office of Research and Development

调查人员

  • 首席研究员：Glenn K Klute, PhD、VA Puget Sound Health Care System Seattle Division, Seattle, WA

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 (估计的)

2026年10月1日

初级完成 (估计的)

2029年1月15日

研究完成 (估计的)

2029年8月1日

研究注册日期

首次提交

2026年2月2日

首先提交符合 QC 标准的

2026年2月2日

首次发布 (实际的)

2026年2月9日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • RRD2-010-25M
  • 1I01RD002103-01 (其他赠款/资助编号：US Department of Veterans Affairs)
  • 1924445 (其他标识符：gov.irbnet.org)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

由拟议研究产生的所有出版物所依据的最终数据集将在VA外部共享。 将创建一个去标识化、匿名化的数据集，并通过VA授权网站向公众开放。 在可能的情况下，研究人员将与手稿出版商合作，将最终研究数据集作为已发表手稿的附录链接。 通过以开放文件格式（例如.txt、.xls、.mat）提供去标识化数据集，并附上清晰记录的处理说明，感兴趣的接收者将能够复制并基于研究人员在出版物中概述的相同技术进行拓展。 将为每个受试者的数据创建一个公共发布标识符（例如APS_001、APS_002），并与去标识化的研究数据随机配对。 数据将包括受试者人口统计信息、测试和问卷结果。 这些数据将无法追踪重新匹配到受试者。 我们的方法将由VAPSHCS隐私官进行验证。

IPD 共享时间框架

在最终研究结果发表后的六个月内。

IPD 共享访问标准

通过PubMed Central、SimTK、PhysioNet或其他类似开源数据存储库网站开放获取。
研究方案、统计分析计划和知情同意书将在clinicaltrials.gov上共享。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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.

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