Understanding how Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

了解动力组件如何影响 K2 级经股截肢者步态

• 批准号: 10585944
• 负责人: Levi John Hargrove
• 金额: $ 67.9万
• 依托单位: REHABILITATION INSTITUTE OF CHICAGO D/B/A SHIRLEY RYAN ABILITYLAB
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10585944
• 关键词: Activities of Daily Living; Affect; Algorithms; American; Amputation; Amputees; Ankle; Biomechanics; Categories; Classification; Clinical; Common Data Element; Communities; Data; Devices; Employment; Energy Metabolism; Equilibrium; Evaluation; Femur; Gait; Generations; Goals; Individual; Intention; Joints; Knee; Knee Prosthesis; Knee joint; Learning; Leg; Leisure Activities; Limb Prosthesis; Limb structure; Lower Extremity; Measures; Medicare; Metabolic; Microprocessor; Outcome; Outcome Measure; Outcome Study; Patient Self-Report; Performance; Persons; Population; Prosthesis; Quality of life; Ramp; Randomized; Research; Self-Help Devices; Surveys; Testing; Torque; Training; Triton; United States National Institutes of Health; Walking; Weight; Work; ankle joint; ankle prosthesis; biomechanical test; clinical decision-making; clinical training; cost; disability; energy efficiency; expectation; foot; functional improvement; gait rehabilitation; improved; improved mobility; innovation; light weight; novel; powered prosthesis; preference; primary outcome; recruit; secondary outcome

Project Summary Powered prosthetic knee and ankle joints can actively generate torque, potentially enabling safe and efficient performance of more demanding mobility tasks, such as ascending ramps and stairs or performing sit-to-stand transitions, and improving energy efficiency. However, available powered components have been almost exclusively developed for and tested by individuals ambulating at Medicare Functional Classification Level (MFCL) K3-or K4. Individuals designated as K2-level ambulators (i.e., have a more limited ambulation capacity) are typically prescribed a passive prosthesis, but these individuals have been shown to benefit from more advanced microprocessor-controlled knees and may gain additional benefit from powered components. Because available powered components are heavy, we developed lightweight, fully powered knee and ankle components that can be used separately or together and are appropriate for K2-level ambulators. These devices will allow us to evaluate the benefits associated with providing power at the knee, ankle, or knee and ankle, and the tradeoffs associated with the additional weight and control complexity of one or more powered components. Our goal is to determine how powered prosthetic components effect function—in terms of metabolic cost, gait biomechanics, and functional mobility in K2-level ambulators with a unilateral transfemoral amputation, who use a prescribed passive prosthesis. We will recruit 20 individuals, who will participate in three aims, with the expectation that 15 will complete the study. For Aim 1, subjects will be fit first with a fully passive device (Ottobock C-Leg 4 MPK and a Triton 1C60 Foot) and then to our fully powered device (knee-+ ankle prosthesis). They will be trained to use each device before completing the Amputee Mobility Predictor with Prosthesis (AMPPRO) (primary outcome) as well as metabolic and biomechanical assessments, a set of standard outcome measures, and self-report surveys (secondary outcomes). For Aim 2, we will evaluate combinations of powered knee + passive ankle and passive knee + powered ankle, in random order. Subjects will be trained to use each device, and the same primary and secondary outcome measures will be performed to assess functional benefits and the effects of additional weight at the knee or ankle. In Aim 3, we will provide intensive training to enable subjects to independently perform typical activities of daily living and achieve personal mobility goals using the powered knee + ankle device, to determine what level of improvement K2- level ambulators can attain. Subjects will again complete the same primary and secondary outcome measures using the powered device and will repeat these measures using the passive device from Aim 1, to accommodate carryover of training effects from previous Aims. The anticipated outcome is an understanding of how power and the weight of prosthetic components affect function in K2-level ambulators, which will enable optimal selection of components to improve functional mobility in individuals who are designated as limited community ambulators and currently restricted to passive devices.

项目摘要 动力的假肢和踝关节可以主动产生扭矩，有可能使安全有效 执行更苛刻的移动任务，例如上升坡道和楼梯或进行静止不动 过渡并提高能源效率。但是，可用的电动组件几乎是 专门为在Medicare功能分类级别AMBUL的个人开发和测试 （MFCL）K3-OR K4。被指定为K2级救护物的个人（即，行走更有限 容量）通常是被动假体的，但这些人已被证明从中受益 更先进的微处理器控制的膝盖，可能会从动力组件中获得额外的好处。 由于可用的动力组件很重，所以我们开发了轻巧，完全动力的膝盖和脚踝 可以分别使用或一起使用并且适合K2级救护物的组件。这些 设备将使我们能够评估与在膝盖，脚踝或膝盖上提供功率相关的收益，然后 脚踝，以及与一个或多个动力的额外重量和控制复杂性相关的权衡 成分。我们的目标是确定动力的假肢成分效应功能 具有单方面的股份 截肢，使用规定的被动假体。我们将招募20个人，他们将参加 三个目标，期望15个将完成这项研究。对于AIM 1，首先将受试者完全适合 被动装置（Ottobock C-Leg 4 MPK和Triton 1C60英尺），然后到达我们的全功率设备（膝盖 - + 脚踝假体）。在完成截肢者移动性预测器之前，他们将接受培训可以使用每个设备 假体（AMPPRO）（主要结果）以及代谢和生物力学评估，一组 标准结果度量和自我报告调查（次要结果）。对于AIM 2，我们将评估 动力的膝盖 +被动脚踝和被动膝盖 +动力脚踝的组合，以随机顺序。主题 将培训使用每个设备，并将执行相同的主要和次要结果指标 评估功能益处以及膝盖或踝关节额外重量的影响。在AIM 3中，我们将提供 强化培训使受试者能够独立地进行日常生活的典型活动 使用动力的膝盖 +踝关节设备的个人移动目标，以确定改进水平的K2-- 水平的救护车可以达到。受试者将再次完成相同的主要和次要结果指标 使用动力设备，并将使用被动设备从AIM 1重复这些措施， 可容纳以前目标的培训效果。预期的结果是对 假肢成分的功率和重量如何影响K2级救护物的功能，这将使 最佳选择组件以提高被指定为有限的个体的功能流动性 社区凶手，目前仅限于被动设备。