An automatically-adjusting prosthetic socket for people with transtibial amputation

适用于小腿截肢患者的自动调节假肢接受腔

• 批准号: 10364108
• 负责人: Joan E. Sanders
• 金额: $ 66.8万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-12 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10364108
• 关键词: Address; Algorithms; Amputation; Amputees; Attention; Clinical Research; Custom; Data; Development; Devices; Elements; Ensure; Environment; Evaluation; Fatigue; Focus Groups; Goals; Health; Individual; Knowledge; Laboratories; Life; Limb structure; Liquid substance; Manuals; Measurement; Modification; Monitor; Participant; Patient Self-Report; Patients; Performance; Persons; Prosthesis; Protocols documentation; Quality of life; Randomized Controlled Trials; Recovery; Reporting; Research; Research Design; Specific qualifier value; Structure; System; Technology; Testing; Time; Update; Upper Extremity; Walking; base; clinical care; design; disability; engineering design; experience; home test; improved; insight; limb amputation; limb loss; model design; novel; performance tests; preference; prosthesis wearer; prosthetic socket; prototype; randomized trial; remote control; residual limb health; satisfaction; sensor

The long-term goal of this research is a prosthetic socket for trans-tibial prosthesis users that continually adjusts size so as to both maintain a proper fit and stabilize limb volume. The socket relieves users of the burden of continually sensing if their socket fit has deteriorated, deciding what adjustment to make, and effecting a socket size change. Users may instead focus on other aspects of their life. The auto-adjusting socket should enhance independence, improve limb health, and enrich patient quality of life. The specific aims are to modify an auto-adjusting socket for Walking previously developed by our group to add a remote key fob interface and two new auto-adjustment algorithms. The compact key fob eliminates a barrier present in the prior design. A Low Activity auto-adjustment algorithm manages socket size to maintain fit during short bouts of walking mixed with standing, as would occur for example when moving about in a building. A Sitting algorithm facilitates limb fluid volume recovery during sitting. The algorithms are optimized through lab- based participant testing. Performance of the complete auto-adjusting socket system is tested in user free-living environments in three modes: auto-adjusting; manual-adjusting; and locked (sock changes only). The aims are accomplished by alternating between clinical studies and engineering design. In the first aim, prototype key fobs are fabricated and evaluated by participants with limb amputation and prosthetists in a qualitative study design. From the results a single design is specified for development. In the second aim, new auto-adjustment algorithms are created and added to the existing on-board control system to maintain fit during combined short bouts of walking and standing (Low Activity) and during sitting (Sitting). Fit is monitored using measurements from custom limb-socket distance sensors embedded in the socket. In a crossover randomized trial, socket comfort, residual limb health, variability in limb fluid volume, and control system error are assessed while participants wear the socket during a structured protocol with all three auto-adjustment functions enabled (Walking, Low Activity, Sitting) compared with only the Walking function enabled. Based on study results, the socket control system is updated accordingly. In the third aim, a crossover randomized trial is conducted in at- home testing where participants wear the socket in auto, manual, and locked modes. In the manual mode, participants adjust the socket using the key fob. Participant self-report scores, residual limb health, prosthesis use, activities, socket fit, number of manual socket adjustments and participant preference are compared. The health relatedness of this application is a reduction of the burden of socket fit monitoring and fit management for patients with limb loss. Rather than having to continually manage their disability, people with limb amputation may live more independent lives. The auto-adjusting socket should also reduce residual limb health complications from poor socket fit. The system may serve as a model for design of technologies that address other levels of amputation (e.g., transfemoral, upper-limb) where automatic adjustment to maintain fit is needed.

这项研究的长期目标是为经胫骨假体使用者提供一种可持续调整的假体插座 大小，以保持适当的适合性和稳定的肢体体积。该套接字减轻了用户的负担 不断检测其插座适合性是否恶化，决定进行何种调整，并实现插座 大小变了。相反，用户可能会关注他们生活的其他方面。自动调节插座应加强 独立，改善肢体健康，丰富患者的生活质量。 具体目的是对本课题组此前开发的行走自动调节插座进行修改，增加 一个远程钥匙卡接口和两个新的自动调整算法。紧凑的密钥卡消除了障碍 呈现在先前的设计中。低活跃度自动调整算法管理插座大小以保持健康 短时间的步行和站立混合在一起，例如在建筑物中走动时就会发生这种情况。一个 坐姿算法有助于在坐姿时恢复肢体体液容量。通过实验室对算法进行了优化。 基于参与者测试。完整的自动调节插座系统的性能在用户自由生活中进行了测试 环境有三种模式：自动调整、手动调整和锁定(仅更改袜子)。 这些目标是通过在临床研究和工程设计之间交替实现的。第一个目标是， 原型关键假体由截肢参与者和假肢修复者在一个 定性研究设计。从结果中，指定了用于开发的单一设计。在第二个目标中，新 自动调整算法被创建并添加到现有的车载控制系统中，以在 步行和站立(低活动量)和坐姿(坐姿)相结合的短程运动。FIT使用以下工具进行监控 通过嵌入插座中的定制肢体插座距离传感器进行测量。在随机的交叉中 评估试验、插座舒适性、残肢健康、肢体液体容量的变异性和控制系统误差。 当参与者在启用了所有三个自动调整功能的结构化协议期间佩戴插座时 (步行、低活动量、坐着)与仅启用步行功能相比。根据研究结果， 插座控制系统相应更新。在第三个目标中，在以下地点进行交叉随机试验： 在家庭测试中，参与者在自动、手动和锁定模式下佩戴插座。在手动模式中， 参与者使用钥匙卡调整插座。参与者自我报告分数、残肢健康、假体 比较了使用、活动、插座适合性、手动插座调节次数和参与者偏好。 此应用程序的健康相关性在于减轻了插座适配监控和适配管理的负担 适用于肢体丧失的患者。与不得不持续管理他们的残疾相比，截肢的人 可能会过上更独立的生活。自动调节插座也应该减少残肢的健康 插座适合性差引起的并发症。该系统可以用作设计解决以下问题技术的模型 需要自动调整以保持适合性的其他截肢水平(例如，经股、上肢)。