Socket design, limb health and ability to ambulate

插座设计、肢体健康和行走能力

• 批准号: 8471021
• 负责人: Joan E. Sanders
• 金额: $ 31.06万
• 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/8471021
• 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; limb amputation; 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.

描述（由申请人提供）：拟议的研究的目的是确定插座在多大程度上影响使用假肢纵横截肢的人的健康和生活质量。这项研究的临床相关性是根据当前的实践促进基于假体拟合而不是假体使用持续时间的插座替换的定量标准。具体的目的是表征由于减少剩余的肢体体积减少而替换为跨态插座的体积变化，并表征每日残留的肢体量变化，步态稳定性，舒适性，舒适性和对假体的满意度以及对使用替代插座的人的活动水平的差异，并将其与其原始的Aspresscred Aspresscred sockscriblesscribleds coppersspocks相反。为了实现目标，确定了替换和原始插座之间的体积差异，通常是针对其插座替换的患者而导致的，这是由于减少肢体量减少而被替换的。然后，使用自动化的制造方法来制作具有跨刻度截肢受试者人群的已知和量化插座体积差异（相对于原始的ASPRESCRECT插座）的假肢测试插座。一个月的磨损期后，为每个研究参与者评估结果。生物阻抗分析用于评估每日残留的肢体体积变化，步态分析，以评估步行模式的变异性，主观的调查工具，以评估假体的满意度和舒适度，袜子监视器以评估袜子层的变化以及便携式步态监控器以评估整体活动。评估假设以确定与原始的ASPRESCRECT插座相比，患者戴上测试插座的扩大时，结果变量是否显着差异。拟议的应用与公共卫生的相关性更好地理解了插座拟合的方式，从而影响了假体，与残留肢体健康有关的临床最重要的结果以及传统上在假体研究中衡量的绩效指标。目前，尚不清楚合适的插座如何影响每日的肢体体积变化，功能性能，对假体，舒适，袜子层变化以及肢体截肢的个体的活动水平。除了赠款期之外，预计拟议的研究将扩展到临床工具中，使从业人员可以将插座设计问题与其他问题（例如组件或对齐不当）隔离。潜在地，这里描述的努力可以扩展到其他领域，包括跨妇女假肢，上limb假肢和矫形器。