Development of a Foot-Ankle Prosthesis to Improve Physical Therapy Outcomes

开发足踝假体以改善物理治疗效果

• 批准号: 10155105
• 负责人: Andrew H. Hansen
• 金额: --
• 依托单位: MINNEAPOLIS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10155105
• 关键词: 3-Dimensional; Address; Adult; Aging; Amputees; Ankle; Articular Range of Motion; Balance training; Biomimetics; Clinical; Cognitive; Community Participation; Data; Development; Devices; Diabetes Mellitus; Ensure; Equilibrium; Exercise; Fatigue; Feedback; Future; Goals; Health; Healthcare Systems; Impairment; Individual; Investigation; Kinetics; Learning; Legal patent; Licensing; Limb Prosthesis; Limb structure; Lower Extremity; Mechanics; Methods; Modification; Motion; Movement; Multi-Institutional Clinical Trial; Outcome; Patients; Performance; Periodicity; Physical therapy; Population; Posture; Process; Prosthesis; Protocols documentation; Quality of life; Rehabilitation therapy; Standardization; Structure; System; Technology Transfer; Testing; Therapeutic Intervention; Time; Training; Vascular Diseases; Veterans; Walking; Weight; Work; ankle prosthesis; balance recovery; base; cost; design; experience; falls; flexibility; foot; human subject; improved; improved mobility; interest; kinematics; limb amputation; locomotor tasks; motor learning; novel; novel strategies; physical therapist; programs; prosthesis wearer; prosthetic foot; social; standard of care; therapy design; therapy outcome; tool; trial comparing

Reduced balance and balance confidence are common impairments among individuals with lower-limb amputations. It is therefore important to develop and evaluate therapeutic interventions designed to improve balance and balance confidence in this population. Conventional approaches to balance training currently involve weight-shifting and stepping exercises that challenge single-limb stance and balance recovery. During this time, new prosthesis users typically wear a flexible prosthetic foot-ankle mechanism designed for walking. Although individuals with lower-limb amputations eventually adapt to the sudden balance requirements of their new prosthesis, their confidence is likely influenced by a persistent threat of falling. The long-term goal of this work is to compare a conventional approach of balance training with a modified program in which the balance requirements of the prosthesis user are gradually increased. To vary the balance requirements of the prosthesis user, a novel foot-ankle device will be developed at the Minneapolis VA Health Care System (MVAHCS), which will allow therapists to gradually adjust the stability of the foot-ankle system as patients learn to safely transfer weight over their prosthesis. This new device will enable physical therapists to maximize stability at the beginning of physical therapy, thereby allowing patients to weight shift with a highly stable system. As the patient's confidence increases, therapists will be able to gradually decrease the stability of the device. The primary goals of our development work will be to develop a prosthetic foot-ankle system that is durable and that allows for easy adjustments (i.e., a system that requires little extra training or tools to accomplish). Consideration will also be given to a method of tracking these adjustments so that therapists can document the patient's progress during the course of physical therapy. Following each design iteration, we will mechanically test the foot-ankle system for static proof, ultimate strength, and cyclic fatigue according to the ISO 10328 standard for lower-limb prosthetic components. We will then perform human subject testing to assess the standing and walking performance of the device and obtain feedback to guide design modifications. Using three-dimensional motion analysis and a clinical balance assessment system, we will collect kinematic, kinetic, and postural stability data on a group of experienced prosthesis users (n=8) while they stand and walk with the proposed foot-ankle system. The goal of this testing will be to ensure biomimetic function of the ankle and verify expected kinematic changes with regard to its range-of-motion settings. We will also conduct human subject testing on a group of new amputees (n=4) undergoing physical therapy at the MVAHCS, which will provide an opportunity for the prosthetists and physical therapists involved in the study to gain experience with the device. In parallel with our development efforts, we will develop a physical therapy protocol that leverages the unique features of the foot-ankle system. The goal of this effort will be to provide an integrated solution to balance training for Veterans with lower-limb amputations. Finally, we will implement an appropriately scoped quality management system to document design criteria, reduce overall development costs, and increase the likelihood of technology transfer. Ultimately, we believe that the foot-ankle system developed in this project will lead to new approaches of physical therapy for individuals with lower-limb amputations, improving mobility, participation in social activities, and quality of life for this population.

平衡和平衡信心下降是下肢残疾人常见的障碍。 截肢因此，重要的是开发和评估旨在改善的治疗干预措施， 平衡和平衡的信心在这个人口。目前，平衡训练的传统方法 涉及挑战单肢站立和平衡恢复的重量转移和踏步练习。期间 这一次，新的假肢使用者通常佩戴为行走而设计的柔性假肢脚-踝机构。 虽然下肢截肢的人最终适应了他们突然的平衡要求， 新的假肢，他们的信心可能会受到持续的跌倒威胁的影响。 这项工作的长期目标是比较传统的平衡训练方法与改进的平衡训练方法。 假肢使用者的平衡要求逐渐提高的程序。改变平衡 为了满足假肢使用者的要求，明尼阿波利斯VA健康中心将开发一种新型的足踝装置。 护理系统（MVAHCS），这将允许治疗师逐渐调整脚踝系统的稳定性， 患者学会了将重量安全地转移到他们的假肢上。这种新设备将使物理治疗师能够 在物理治疗开始时最大限度地提高稳定性，从而使患者能够以高度的 稳定系统随着患者信心的增加，治疗师将能够逐渐降低稳定性 的装置。 我们开发工作的主要目标是开发一种耐用的假肢脚踝系统 并且允许容易的调节（即，一个几乎不需要额外培训或工具即可完成的系统）。 还将考虑一种跟踪这些调整的方法，以便治疗师可以记录这些调整。 患者在物理治疗过程中的进展。在每次设计迭代之后，我们将机械地 根据ISO 10328测试足踝系统的防静电、极限强度和循环疲劳 下肢假肢部件标准。然后我们将进行人体试验，以评估 设备的站立和行走性能，并获得反馈以指导设计修改。使用 三维运动分析和临床平衡评估系统，我们将收集运动，动力， 以及一组有经验的假体使用者（n=8）在站立和行走时的姿势稳定性数据。 建议的脚踝系统。这项测试的目标是确保踝关节的仿生功能， 验证与其活动范围设置相关的预期运动学变化。我们还将进行人类 在MVAHCS接受物理治疗的一组新截肢者（n=4）的受试者测试， 为参与研究的修复师和物理治疗师提供机会， 设备.在我们的开发工作的同时，我们将开发一个物理治疗方案， 踝足系统的独特功能。这项工作的目标是提供一个综合解决方案， 下肢截肢退伍军人的平衡训练。最后，我们将实现一个适当范围的 质量管理体系，以文件设计标准，降低整体开发成本，并增加 技术转让的可能性。最终，我们相信，在这个项目中开发的脚踝系统将 为下肢截肢者提供新的物理治疗方法，改善活动能力， 参与社会活动，以及这一群体的生活质量。