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: 10663789
• 负责人: Joan E. Sanders
• 金额: $ 64.62万
• 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/10663789
• 关键词: Address; Algorithms; Amputation; Amputees; Attention; Clinical Research; Custom; Data; Deterioration; Development; Devices; Elements; Ensure; Environment; Evaluation; Fatigue; Femur; 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; 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假肢接受腔， 以保持适当配合和稳定肢体体积。该插座减轻了用户的负担， 不断地感知他们的插座配合是否已经恶化，决定进行什么调整，并实现插座 尺寸变化。用户可以转而关注他们生活的其他方面。自动调节插座应加强 独立性，改善肢体健康，丰富患者生活质量。 具体目标是修改我们小组以前开发的自动调节行走插座， 一个遥控钥匙接口和两个新的自动调整算法。紧凑的密钥卡消除了障碍 存在于现有设计中。低活动自动调整算法管理插槽大小，以在 短时间的步行与站立混合，例如在建筑物中移动时会发生。一 坐姿算法有助于坐姿期间肢体液体容量的恢复。算法通过实验室优化- 参与者测试。在用户自由生活中测试了完整的自动调节插座系统的性能 在三种模式下的环境：自动调整;手动调整;和锁定（袜子变化只）。 这些目标是通过临床研究和工程设计之间的交替来实现的。在第一个目标中， 原型密钥卡制造和评估的参与者与截肢和假肢专家在一个 定性研究设计。根据结果，指定单个设计用于开发。第二个目标，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 结合短时间的步行和站立（低活动）以及坐着期间（坐着）。使用以下方法监测拟合 从嵌入在插座中的定制肢体插座距离传感器测量。在一个交叉随机 评估试验、接受腔舒适度、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套接字时 （步行、低活动、坐姿）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，交叉随机试验是在- 家庭测试，参与者在自动、手动和锁定模式下佩戴插座。在手动模式下， 参与者使用密钥卡调整插座。参与者自我报告评分，残肢健康，假体 比较使用、活动、插座适配、手动插座调整次数和参与者偏好。 该应用程序的健康相关性减轻了插座适配监测和适配管理的负担 对于肢体缺失的患者。截肢者不必继续管理他们的残疾， 可以过更独立的生活。自动调节插座也应该减少残肢健康 关节窝配合不良的并发症。该系统可以用作解决以下问题的技术的设计的模型： 其它水平的截肢（例如，经股动脉、上肢），其中需要自动调节以保持配合。