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 动力假肢膝关节和踝关节可以主动产生扭矩， 执行要求更高的移动任务，如爬坡道和楼梯或执行坐站转换 转型，提高能源效率。然而，可用的动力部件几乎 专为处于Medicare功能分类级别的步行者开发并进行测试 （MFCL）K3-或K4。被指定为K2级流动人员的个人（即，有一个更有限的amounts 能力）通常规定被动假肢，但这些人已被证明受益于 更先进的微处理器控制的膝盖，并可能获得额外的好处，从动力组件。 由于现有的动力组件很重，我们开发了轻量级，全动力膝盖和脚踝 可单独使用或一起使用的组件，适用于K2级移动设备。这些 这些设备将使我们能够评估与在膝盖、脚踝或膝盖处提供动力相关的益处， 脚踝，以及与一个或多个动力的附加重量和控制复杂性相关的权衡 件.我们的目标是确定动力假体部件如何影响功能--就 单侧经股动脉K2级步行者的代谢成本、步态生物力学和功能活动度 截肢，使用规定的被动假肢。我们将招募20名个人，他们将参加 三个目标，预计将有15人完成研究。对于目标1，受试者将首先适应完全 无源设备（Ottobock C-Leg 4 MPK和Triton 1C 60 Foot），然后到我们的全动力设备（膝关节-+ 踝关节假体）。在完成截肢者移动预测之前，他们将接受使用每种器械的培训 假体（AMPPRO）（主要结局）以及代谢和生物力学评估， 标准结果测量和自我报告调查（次要结果）。对于目标2，我们将评估 动力膝关节+被动踝关节和被动膝关节+动力踝关节的组合，以随机顺序。科目 将接受使用每种器械的培训，并将执行相同的主要和次要结局指标 评估膝关节或踝关节的功能益处和额外重量的影响。在目标3中，我们提供 强化训练，使受试者能够独立进行典型的日常生活活动， 使用动力膝关节+踝关节设备的个人移动目标，以确定K2- 能达到的水平。受试者将再次完成相同的主要和次要结局指标 使用受电设备，并将使用目标1中的无源设备重复这些措施，以 适应从以前的目标的培训效果结转。预期的结果是理解 假肢组件的功率和重量如何影响K2级步行机的功能，这将使 最佳选择组件，以改善被指定为受限的个体的功能移动性 社区救护车，目前仅限于无源设备。