Robotic Knee Exoskeleton to Reduce Joint Loading and Improve Mobility in Veterans with Medial Compartment Knee Osteoarthritis

症状性膝骨性关节炎(OA)是一种疼痛的疾病，它会降低活动度、独立性和关节功能的质量 男人和女人的生活。在55岁以上的人中，约有10%的人患有痛性膝盖骨关节炎 其中四分之一是严重残疾的人。尽管有多种因素影响骨性关节炎的发病机制， 膝关节内侧间隙接触负荷起着重要的作用，而且重要的是，这是一种可以改变的风险。 因素。传统的膝关节脱机支架是一种常见的保守治疗策略，对于那些中间的 膝盖骨。卸料器支架是用来卸载膝关节内侧间隙的。 从而减缓疾病进展，减轻疼痛，改善关节功能和活动能力。内侧 支撑外展力矩(BAM)提供的间隔室卸载抵消了外膝 内收力矩(Kam)。不幸的是，传统的膝关节卸荷器支具的疗效参差不齐。 佩戴支具的好处(最小程度的减轻疼痛和轻微的功能改善)并不常见 胜过支架的不适和使用上的麻烦。传统的膝盖式卸料器支架的缺点之一 BAM必须由支具使用者通过背带和/或髁状突垫调整来手动设置。这 导致不频繁的调整，这通常会导致给定活动的BAM设置不适当，例如 背带松动导致BAM在步态过程中不能提供足够的膝关节卸载，或者 受试者处于静止状态，但BAM仍然较高，导致支架界面出现压力和不适。连 当步行时，一步内的BAM调制可能是有益的。在这种情况下，BAM可能会在 摆动阶段，但随后在站立阶段恢复到正常水平。基于这些原因，我们建议一个新的 一类智能主动大括号，可动态适应给定个体及其 活动。这种新类型的支架有可能提供更大的内侧膝关节间隙卸载和 在更舒适的同时，更好地缓解疼痛。因此，这项研究的目的是 研究是确定提供更好的内侧膝关节的最佳BAM调制轮廓 与传统的被动膝关节相比，卸载，提高支架舒适性，减少膝关节疼痛 卸料机支架。为了实现我们的目标，我们开发了一种非机载机器人膝关节外骨骼(RKE)，以 作为实验室工具，研究采用动态BAM调制的有源支撑的潜在优势。 在这项研究中，20名参与者将被招募在仪表式跑步机上行走，同时穿着 (RKE)。参与者将体验由BAM参数化的56种不同的BAM调制方案 打开时间(TON)、关闭时间(TOFF)和峰值Nm BAM电平(PK)。实时数据分析将使我们能够 立即比较每种BAM调制方案对内侧膝关节的疗效 卸载(膝内收角冲量，KaAI)和支具舒适性(支具外展角冲量，BAAI)。 然后，研究参与者将直接体验步行与RKE模拟传统 被动卸货机支架与RKE步行与确定最佳BAM编程的RKE。在这里， 参与者将为每种支架类型自行选择自己的首选卸载级别(BAM PK)。自我报告 膝关节疼痛和支具舒适度，以及被动支具与主动支具的KAAI和BAAI 比较一下。这些结果将使我们能够确定提供步内BAM的动态主动支架 调制可以提供相等或更好的内侧膝关节卸载(KaAI)，同时 更舒适，更好地缓解疼痛。改进的膝盖式卸料器支架的开发，它是智能的， 动态化、适应性强，有可能极大地提高支具效能。改进的保守治疗 膝内侧骨性关节炎的治疗策略可以减少手术干预及其相关风险 显著改善背负这种疾病的退伍军人的生活质量。

Symptomatic knee osteoarthritis (OA) is a painful condition that reduces mobility, independence, and quality of life for both men and women. About 10% of people aged over 55 years have painful disabling knee OA of whom one quarter are severely disabled. Although a variety of factors influence the pathogenesis of OA, medial compartment knee joint contact loading plays a significant role and importantly, is a modifiable risk factor. Traditional knee unloader braces are a common conservative treatment strategy for those with medial compartment knee OA. Unloader braces are designed to unload the medial compartment of the knee joint thereby slowing disease progression, reducing pain, and improving joint function and mobility. Medial compartment unloading provided by a brace abduction moment (BAM) counteracts the external knee adduction moment (KAM). Unfortunately, traditional knee unloader braces have mixed efficacy and the limited benefits (minimal reduction in pain and minor functional improvements) of wearing the brace do not often outweigh the brace discomfort and hassle of use. One of the shortcomings of traditional knee unloader braces is that the BAM must be manually set by the brace user through strapping and or condyle pad adjustment. This results in infrequent adjustment which often causes an inappropriate BAM setting for a given activity, e.g. strapping has loosened resulting in a BAM that doesn’t provide enough knee unloading during gait, or the subject is at rest but the BAM remains high causing pressure and discomfort at the brace interface. Even when walking BAM modulation within a step could be beneficial. In this scenario, BAM could be reduced during swing phase but then return to a normal level during stance phase. For these reasons, we propose that a new class of smart active braces that dynamically adapt the amount of unloading for a given individual and their activity. This new class of braces has the potential to provide greater medial compartment knee unloading and better pain relief while simultaneously being more comfortable. Therefore, the purpose of this research study is to determine optimal BAM modulation profiles that provide better medial compartment knee unloading, improve brace comfort and reduce knee pain as compared to conventional passive knee unloader braces. To achieve our aims, we have developed an offboard robotic knee exoskeleton (RKE) to serve as a laboratory tool to investigate the potential benefits of active braces with dynamic BAM modulation. For this study, twenty participants will be recruited to walk on an instrumented treadmill while wearing the (RKE). The participants will experience 56 different BAM modulation schemes as parameterized by the BAM turn on time (Ton), turn off time (Toff) and peak Nm BAM level (Pk). Real-time data analysis will allow us to immediately compare the efficacy of each BAM modulation scheme in terms of medial compartment knee unloading (knee adduction angular impulse, KAAI) and brace comfort (brace abduction angular impulse, BAAI). Study participants will then experience a direct comparison of walking with the RKE emulating a traditional passive unloader brace versus walking with the RKE programmed with the identified optimal BAM. Here the participants will self-select their own preferred unloading level (BAM Pk) for each brace type. Self-reported knee pain and brace comfort, as well as KAAI and BAAI of the passive versus active brace will then be compared. These results will allow us to determine if dynamic active braces that deliver intra-step BAM modulation can provide equal or better medial compartment knee unloading (KAAI) while simultaneously being more comfortable and greater pain relief. The development of improved knee unloader braces, that are smart, dynamic, and adaptive have the potential to greatly increase brace efficacy. Improved conservative treatment strategies for medial compartment knee OA could reduce surgical intervention and its associated risks and significantly improve the quality of life for veterans burdened by this disease.