Socket design, limb health and ability to ambulate

描述（由申请人提供）：拟议研究的目标是确定过大的承窝对使用假肢进行经胫骨截肢的个体的健康和生活质量的影响程度。这项研究的临床意义是促进基于假体适合性而不是假体使用时间的接受腔置换的定量标准，这是目前的做法。具体目的是表征由于残肢体积减小而通常对经胫骨接受腔进行置换的体积变化，并表征使用扩大接受腔进行经胫骨截肢的个体与使用原始规定接受腔进行经胫骨截肢的个体在日常残肢体积变化、步态稳定性、舒适度和对假体的满意度以及活动水平方面的差异。为了实现这些目标，确定了由于残肢体积减小而进行承窝置换的患者通常所做的置换承窝和原始承窝之间的体积差。然后使用自动化制造方法来制造假体测试接受腔，该假体测试接受腔具有用于经胫骨截肢者受试者群体的已知和量化的接受腔体积差异（相对于原始规定接受腔）。在一个月的佩戴期后，对每个研究参与者的结果进行评估。生物阻抗分析用于评估每日残肢液体体积变化，步态分析用于评估行走模式的变化，主观调查仪器用于评估假肢的满意度和舒适度，袜子监测器用于评估袜子厚度变化，便携式步态监测器用于评估整体活动。对假设进行评价，以确定患者佩戴扩大的测试牙槽窝与原始处方牙槽窝相比，结果变量是否存在显著差异。拟议的应用程序与公共卫生的相关性是更好地了解承窝配合如何影响用户使用假肢的体验，与残肢健康相关的临床重要结果，以及传统上在假肢研究中测量的性能指标。目前，尚不清楚适配不良的承窝如何影响截肢个体的日常肢体体积变化、功能性能、对假体的满意度、舒适度、袜层变化和活动水平。在资助期之后，预计拟议的研究将扩展到临床工具，使从业者能够将插座设计问题与其他问题（如组件不当或对齐）隔离开来。潜在地，这里描述的努力可以扩展到其他领域，包括经股骨假肢，上肢假肢和矫形器。 公共卫生相关性：该项目的长期目标是一种范式转变，即根据假体适合性而不是假体使用时间（目前的做法）制定接受腔置换的定量指南和标准。

DESCRIPTION (provided by applicant): The goal of the proposed research is to determine to what degree too large a socket impacts the health and quality of life of individuals with transtibial amputation using prosthetic limbs. The clinical relevance of this research is to promote quantitative standards for socket replacement based on prosthetic fit rather than duration of prosthesis use, as is current practice. The specific aims are to characterize volume changes typically made to transtibial sockets replaced because of residual limb volume reduction and to characterize differences in the daily residual limb volume change, gait stability, comfort, and satisfaction with the prosthesis, and activity level for individuals with transtibial amputation using enlarged sockets as opposed to their original as-prescribed sockets. To accomplish the aims, the volume differences between replacement and original sockets typically made for patients having their socket replaced because of residual limb volume reduction are determined. Automated fabrication methods are then used to make prosthetic test sockets that have known and quantified socket volume differences (relative to the original as-prescribed sockets) for a population of transtibial amputee subjects. After one-month wear periods, outcomes are assessed for each study participant. Bioimpedance analysis is used to assess daily residual limb fluid volume change, gait analysis to assess variability in walking patterns, subjective survey instruments to evaluate satisfaction and comfort with the prosthesis, a sock monitor to assess sock ply changes, and a portable gait monitor to assess overall activity. Hypotheses are evaluated to determine if the outcome variables are significantly different when patients wear the enlarged test sockets compared with the original as-prescribed sockets. The relevance of the proposed application to public health is better understanding of how socket fit impacts user experience with a prosthesis, clinically-important outcomes related to residual limb health, and performance measures traditionally measured in prosthetics research. Currently, it is unknown how poorly fitting sockets impact daily limb volume change, functional performance, satisfaction with the prosthesis, comfort, sock ply change, and activity level of individuals with limb amputation. Beyond the grant period, it is anticipated the proposed research will be extended into clinical tools that allow practitioners to isolate socket design problems from other issues such as improper componentry or alignment. Potentially, the efforts described here can be extended to other areas including trans-femoral prosthetics, upper-limb prosthetics, and orthotics. PUBLIC HEALTH RELEVANCE: The long-term goal of this project is a paradigm shift to quantitative guidelines and standards for socket replacement based on prosthetic fit rather than duration of prosthesis use, as is current practice.