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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要动力驱动的膝关节和踝关节假肢可以主动产生扭矩，从而可能实现安全高效执行要求更高的移动任务，例如上坡道和楼梯或执行从坐到站的操作然而，可用的动力组件已经几乎是。专为在 Medicare 功能分类级别行走的个人开发和测试 (MFCL) K3 或 K4 被指定为 K2 级行走者（即行走能力更有限）。能力）通常被指定为被动假肢，但这些人已被证明可以受益于更先进的微处理器控制的膝盖，并可能从供电组件中获得额外的好处。由于可用的动力部件很重，我们开发了轻质、全动力的膝盖和脚踝可以单独或一起使用的组件，适用于 K2 级步行车。设备将使我们能够评估与为膝盖、脚踝或膝盖提供动力相关的好处，以及脚踝，以及与一个或多个动力装置的额外重量和控制复杂性相关的权衡我们的目标是确定动力假肢部件如何影响功能——就以下方面而言：单侧经股动脉 K2 级步行机的代谢成本、步态生物力学和功能活动性截肢，使用规定的被动假肢我们将招募 20 人参加。三个目标，预计 15 名受试者将完成目标 1 的研究，受试者将首先完全适应。被动设备（Ottobock C-Leg 4 MPK 和 Triton 1C60 Foot），然后连接到我们的全动力设备（膝+ 在完成截肢者活动预测器之前，他们将接受使用每种设备的培训。与假体（AMPPRO）（主要结果）以及代谢和生物力学评估，一组标准结果测量和自我报告调查（次要结果），我们将评估目标 2。动力膝关节+被动踝关节和被动膝关节+动力踝关节的组合，顺序随机。将接受使用每种设备的培训，并将执行相同的主要和次要结果测量为了评估膝盖或脚踝的功能益处和额外重量的影响，我们将在目标 3 中提供。强化训练，使受试者能够独立进行日常生活的典型活动并实现使用动力膝+踝装置的个人活动目标，以确定改善的程度 K2- 受试者将再次完成相同的主要和次要结果测量。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，以适应先前目标的培训效果的延续。预期结果是对以下内容的理解。假肢部件的功率和重量如何影响 K2 级步行机的功能，这将使优化组件选择，以改善被指定为受限个体的功能活动能力社区步行车，目前仅限于无源设备。