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对跨式假体使用者的假肢插座，该插座不断调整 尺寸以保持适当的拟合和稳定肢体体积。插座减轻了用户的负担 不断感知其插座拟合是否恶化，决定进行哪些调整并实现插座 尺寸变化。用户可以专注于生活的其他方面。自动调整的插座应增强 独立，改善肢体健康并丰富患者的生活质量。 具体目的是修改自动调整套接字，以使我们小组以前开发的步行插座添加 远程键FOB接口和两个新的自动调整算法。紧凑的密钥FOB消除了障碍 存在于先前的设计中。低活动自动调整算法管理插座尺寸以保持适合度 短暂的步行与站立混合在一起，例如在建筑物中四处走动时会发生。一个 坐着算法有助于坐着时肢体体积恢复。通过实验室优化算法 基于参与者测试。在用户自由生活中测试了完整自动调整插座系统的性能 以三种模式的环境：自动调整；手动调整；并锁定（仅袜子更改）。 目的是通过在临床研究和工程设计之间交替来实现的。在第一个目标中 原型关键FOB是由肢体截肢和假肢的参与者制造和评估的 定性研究设计。从结果中指定了单个设计用于开发。在第二个目标中 创建并添加到现有的车载控制系统中，以保持适合状态，以保持自动调整算法 步行和站立（低活动）和坐着（坐着）的简短回合。使用适合使用 嵌入插座中的自定义肢体距离传感器的测量值。在一个随机的跨界 评估试验，插座舒适性，残留肢体健康，肢体流体体积的变异性和控制系统错误 当参与者在结构化协议期间戴上插座，并启用了所有三个自动调整功能 （步行，低活动，坐着）与仅启用步行功能相比。根据研究结果 插座控制系统已相应更新。在第三个目标中，在AT-进行了跨界随机试验 参与者在自动，手动和锁定模式下佩戴插座的家庭测试。在手动模式下， 参与者使用键FOB调整插座。参与者的自我报告分数，残留肢体健康，假体 比较使用，活动，插座拟合，手动插座调整的数量和参与者偏好。 该应用的健康相关性是减轻插座拟合监控和拟合管理的负担 对于肢体损失的患者。肢体截肢的人不必不断管理自己的残疾 可能过着更多独立的生活。自动调整插座还应减少残留肢体健康 插座不良的并发症。该系统可以作为解决方案设计的模型 需要自动调整以维持拟合度的其他截肢级别（例如，经济，上限）。