SBIR Phase I: Wearable Robotic Knee Osteoarthritis Active Living Assistant - KOAALA

这个小企业创新研究（SBIR）第一阶段项目开发了一种腿部支架，可以监测并潜在地预防膝关节骨关节炎（KOA）的进展。研究表明，膝关节内收/外展力矩（KAM）是KOA进展的一个关键标志，也是管理治疗的一个有价值的工具，但除了最简单的活动外，用现有技术测量膝关节内收/外展力矩是困难和昂贵的。所提出的支具通过在所有日常生活活动（ADL）期间产生高分辨率KAM和步态数据来解决KOA的监测和早期干预，并且通过最小化设备的ADL干扰来减轻客户对佩戴机器人设备的接受，同时使其更容易行走且疲劳更少。也限制了膝关节的最大受力（可能减缓KOA进展，因为重复的高膝关节负荷被认为会加剧KOA）;第一阶段研究目标包括：创建/集成KAM传感器和无线功能到现有设备中;台架测试原型支架;将支架的KAM/步态参数测量与现有KAM/步态测量技术进行比较;并创建早期基础设施软件应用程序，将KAM/步态数据呈现给管理临床医生。 预期的结果包括证明软件开发的可行性和测量的KAM数据相比，有利的现有测量techniques.The更广泛的影响/商业潜力，该项目源于其对KOA的影响，KOA是一种疾病，导致移动功能障碍，估计占世界老年人口的12%。现有的KOA的医疗管理是困难的，部分原因是没有低成本的程序来监测KOA的进展。治疗通常发生在KOA开始干扰日常生活活动之后，通过一个分阶段的过程，从轻度病例的训练计划开始，目标是减少患病膝关节室的胫股力，对于中度疼痛病例，进展到药物和卸载支架，当疼痛变得严重时，以全膝关节置换术（TKR）结束。2010年，美国卫生系统完成的50万例TKR手术的总成本为175亿美元，预计到2030年，350万例TKR手术的成本为1390亿美元。KOA的传统疫苗目前还不存在;拟议的辅助技术相当于一种机器人疫苗，有望通过减少胫股力量来减缓KOA的进展。作为一种高度先进的腿部支具，它还为康复临床医生提供了新的工具，通过远程培训计划来管理症状性KOA疼痛。一个成功的项目将使研究人员能够解决世界上主要的健康问题之一。

This Small Business Innovation Research (SBIR) Phase I project develops a leg-brace that monitors, and potentially prevents the progression of Knee Osteoarthritis (KOA). Research shows that Knee Adduction/abduction Moment (KAM) is a key marker in KOA progression and a valuable tool in managing treatment, but is difficult and expensive to measure with existing techniques for all but the simplest activities. The proposed brace addresses the monitoring and early intervention of KOA by producing high resolution KAM and gait data during all Activities of Daily Living (ADL) and easing customer acceptance of wearing robotic devices by minimizing the device's ADL interference, while making it easier to walk with less fatigue. It also limits the maximum knee joint force (potentially slowing KOA progression, as repetitive high knee joint loadings are believed to exacerbate KOA); Phase I research objectives include: create/integrate KAM sensors and a wireless capability into an existing device; bench test a prototype brace; compare the brace's KAM/gait parameter measurements against existing KAM/gait measurement techniques; and create an early stage infrastructure software application that presents the KAM/gait data to managing clinicians. Anticipated results include demonstrating feasibility of software development and that measured KAM data compares favorably to existing measurement techniques.The broader impact/commercial potential of this project stems from its impact on KOA, a disease causing mobility dysfunction amongst an estimated 12% of the world's elderly population. Existing medical management of KOA is difficult in part because there is no low cost procedure for monitoring KOA progression. Treatment typically occurs after KOA begins interfering with Activities of Daily Living, via a staged process starting with training programs with the goal of reducing the tibiofemoral force on the diseased knee compartment for mild cases, progressing to drugs and offloading braces for moderate pain cases and ending with a Total Knee Replacement (TKR) when the pain becomes severe. Total cost to the US health system for the 500K TKR procedures done in 2010 was $17.5B with projections of 3.5M TKR procedures costing $139B by 2030. A conventional vaccine for KOA currently does not exist; the proposed assistive technology is tantamount to a robotic vaccine with promise to slow KOA progression by reducing tibiofemoral force. A highly advanced leg brace, it also provides new tools for rehabilitation clinicians managing symptomatic KOA pain via training programs in remote settings. A successful project will enable researchers to address one of the world's major health problems.