Socket design, limb health and ability to ambulate

插座设计、肢体健康和行走能力

• 批准号: 8158819
• 负责人: Joan E. Sanders
• 金额: $ 31.12万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8158819
• 关键词: Affect; Amputation; Amputees; Area; Client satisfaction; Clinical; Clinical Research; Confidence Intervals; Cross-Over Studies; Custom; Evaluation; Gait; Goals; Grant; Guidelines; Health; Individual; Laboratories; Length; Limb structure; Liquid substance; Measures; Methods; Monitor; Outcome; Participant; Patient Care; Patients; Pattern; Performance; Population; Prosthesis; Public Health; Quality of life; Questionnaires; Randomized; Relative (related person); Research; Research Design; Residual state; Shapes; Speed; Surveys; Testing; Thick; Time; Upper Extremity; Walking; Width; base; clinically relevant; design; experience; gait examination; improved; instrument; orthotics; prosthesis fitting; satisfaction; tool

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.

描述（由申请人提供）：拟议研究的目标是确定太大的接受腔对使用假肢进行小腿截肢的个体的健康和生活质量产生何种程度的影响。这项研究的临床意义是促进基于假体贴合而不是假体使用持续时间的接受腔置换的量化标准，就像目前的做法一样。具体目的是表征由于残肢体积减少而导致的经小腿接受窝更换的典型体积变化，以及表征经小腿骨折患者的日常残肢体积变化、步态稳定性、舒适度和对假肢的满意度以及活动水平的差异。使用扩大的接受腔而不是原来的规定接受腔进行截肢。为了实现这些目标，确定了通常为因残肢体积减小而更换接受腔的患者制作的替换接受腔和原始接受腔之间的体积差异。然后使用自动化制造方法来制造假肢测试插座，这些假肢测试插座已为一群经胫骨截肢者受试者已知并量化了插座体积差异（相对于原始规定的插座）。经过一个月的佩戴期后，将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，步态分析用于评估步行模式的变异性，主观调查工具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层的变化，便携式步态监测器用于评估整体活动。评估假设以确定当患者佩戴扩大的测试插座与原始处方插座相比时结果变量是否显着不同。所提出的应用与公共卫生的相关性在于更好地理解接受腔配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假肢研究中传统测量的性能指标。目前，尚不清楚不合适的插座如何影响肢体截肢者的日常肢体体积变化、功能表现、对假肢的满意度、舒适度、袜层变化和活动水平。在资助期结束后，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（例如不正确的组件或对齐）隔离开来。这里描述的努力可能会扩展到其他领域，包括经股假肢、上肢假肢和矫形器。 公共健康相关性：该项目的长期目标是转变为基于假肢贴合而不是假肢使用持续时间的接受腔更换的定量指南和标准，就像目前的做法一样。