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插座对使用假肢的经胫骨截肢患者的健康和生活质量的影响程度。这项研究的临床意义在于推广基于假体适合性的窝置换的量化标准，而不是像目前的做法那样，基于假体的使用时间。其具体目的是描述由于残肢容量减少而替换的经胫骨插座的典型体积变化，以及使用扩大插座的经胫骨截肢患者与原来规定的插座相比在每日残肢体积变化、步态稳定性、舒适性和对假体的满意度以及活动水平方面的差异。为了达到这些目的，确定了替换插座和原始插座之间的体积差，这些插座通常是为因残肢体积减少而被替换的患者制造的。然后使用自动化制造方法来制造假体测试插座，该假体测试插座具有已知的和量化的插座体积差异(相对于原始的规定插座)，用于经胫骨截肢受试者的人群。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余肢体液体量的变化，步态分析用于评估步行模式的变异性，主观调查仪器用于评估假体的满意度和舒适性，袜子监测器用于评估袜层的变化，便携式步态监测器用于评估整体活动度。对假设进行评估，以确定当患者佩戴扩大的测试插座时，结果变量是否与原始的规定插座显著不同。拟议的应用程序与公共健康的相关性是更好地理解接受腔适配如何影响假肢的用户体验、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衡量的性能指标。目前，不合适的插座如何影响截肢患者的日常肢体体积变化、功能表现、对假体的满意度、舒适性、袜层更换和活动水平尚不清楚。在授权期过后，预计拟议的研究将扩展到临床工具，允许从业者将插座设计问题与其他问题隔离，如不正确的组件或对齐。潜在地，这里描述的努力可以扩展到其他领域，包括经股动脉假体、上肢假体和矫形术。 公共卫生相关性：该项目的长期目标是根据假体适合性而不是目前的做法，向基于假体适合性的插座更换的定量指南和标准转变。

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.