Socket design, limb health and ability to ambulate

描述（由申请人提供）：拟议研究的目的是确定过大的椎窝在多大程度上影响使用义肢的经胫骨截肢患者的健康和生活质量。本研究的临床意义在于促进基于假体配合度而不是假体使用时间的假体置换的定量标准，这是目前的做法。具体目的是表征由于残肢体积减少而更换的残肢窝的体积变化，以及表征使用扩大的残肢窝与使用原规定的残肢窝相比，残肢窝日常体积变化、步态稳定性、舒适度、假体满意度和活动水平的差异。为了达到目的，确定因残肢体积缩小而进行骨臼置换术的患者通常使用的替代骨臼与原始骨臼之间的体积差异。然后使用自动化制造方法制作已知和量化的义肢测试套孔（相对于原始的按规定的套孔），用于胫骨截肢者人群。经过一个月的佩戴期后，对每位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量变化，步态分析用于评估行走模式的可变性，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。对假设进行评估，以确定当患者佩戴放大的测试套与原始规定套时，结果变量是否显着不同。拟议的应用与公共卫生的相关性是更好地理解插槽适合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，以及传统假肢研究中测量的性能指标。目前，尚不清楚不合适的关节套对截肢者日常肢体体积变化、功能表现、对假肢的满意度、舒适度、袜子厚度变化和活动水平的影响。在资助期之后，预计拟议的研究将扩展到临床工具，使从业者能够将套管设计问题与其他问题（如不适当的组件或对准）隔离开来。潜在地，这里描述的努力可以扩展到其他领域，包括经股假肢，上肢假肢和矫形器。

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.