Design Improvements and Evaluation of a Knee Stress-Relief Powered Exoskeleton for Veterans with Knee Osteoarthritis

膝关节骨关节炎（OA）是一个日益严重的问题，由于增加寿命和肥胖，估计有1400万 有这种缺陷的人膝关节OA导致活动减少和生活方式改变，进一步 使一个人的健康恶化。外骨骼技术（Keeogo™，B-temia，Inc.）可能是一个可行的选择 标准膝关节OA治疗提供动力支持，以减少移动过程中的疼痛。初步 在6名膝关节OA患者中进行的Keeogo™研究显示，在不同的治疗期间， 机动性任务。然而，一个调整指南，以促进更好的可用性，由临床医生和退伍军人与膝关节OA， 关于器械如何提供主动辅助的生物力学知识，以及实验室评价 缺乏与标准膝关节支架相比的性能结果。无公开处方， 用于膝关节骨性关节炎退伍军人的调整和一般指南也被确定为局限性。 该提案有四个目标：目标1）为KeeogoTM开发一个膝关节OA特定的调谐指南， 最大限度地提高用户的移动性活动，减少不同严重程度膝关节OA的疼痛;目标2） 检查膝关节OA退伍军人对Keeogo™提供的主动辅助的生物力学反应 与标准护膝提供的被动辅助相比;目标3）在实验室内评估 与标准膝关节相比，KeeogoTM的移动性结局、疼痛感知和用户满意度 目的4）制定膝关节OA外骨骼使用的处方和调整建议 装置.目标1和目标4是开发项目，不产生假设。两个假设（H）是 针对目标2进行的测试包括：H2.1）在站立阶段，使用KeeogoTM行走时膝关节内收力矩较小 (KAM)、膝关节屈曲力矩（KFM）和肌肉协同收缩。这些 变量已被证明与内部关节负荷以及疾病进展和疼痛有关; H2.2） 在摆动阶段，使用KeeogoTM行走将显示出更大的膝关节活动范围（ROM）、步幅和脚 比标准的膝关节支架行走更安全。这些变量已被证明与止痛步态 因为膝盖疼痛。为目标3检验的两个假设是：H3.1）以显示改进的性能 活动性测试结果，包括6分钟步行测试、计时起身测试、13步楼梯测试、捡硬币测试 从地板测试，和短期物理性能电池（SPPB）时，使用KeeogoTM相比， 他们的规定膝盖支架和H3.2），以显示减少疼痛与KeeogoTM的数字疼痛评级量表 （NPRS）与规定的膝关节支架进行移动性测试。 该研究将在两个VA医疗中心进行。将制定膝关节OA特定的调整方案 (Aim 1）并分别用于20名和26名患有膝关节OA的退伍军人的实验室内评估（目标3） 詹姆斯J彼得斯退伍军人医疗中心，布朗克斯，纽约州。生物力学研究（目标2）将在24 退伍军人与膝关节OA在弗吉尼亚州匹兹堡卫生系统人类工程研究实验室， 宾夕法尼亚州匹兹堡两个研究中心的研究人员将共同撰写处方和调律 目标4：为公众服务。 预期结果：调整指南将有助于更快的拟合和参数调整，生物力学 预期研究将确定器械使用过程中的潜在作用机制，实验室研究 预期将表现出改善的步行速度、爬楼梯/下楼梯时间、改善的坐立、站立- 从地板上取回物体，减少患者报告的疼痛;膝关节OA特异性 处方和调音指南将提供给公众使用。

Knee osteoarthritis (OA) is a growing problem due to increased longevity and obesity with estimates of 14 million people living with this impairment. Knee OA results in decreased activity and lifestyle changes, further exacerbating an individual’s health. Exoskeleton technology (Keeogo™, B-temia, Inc.) may be a viable alternative to standard knee OA treatment by providing powered support to reduce pain during mobility. Preliminary studies with the Keeogo™ in six persons with knee OA showed efficacy for pain reduction during different mobility tasks. However, a tuning guide to promote better usability by clinicians and Veterans with knee OA, knowledge about the biomechanics of how the device provides active assistance, and an in-laboratory evaluation of performance outcomes compared with standard knee braces are lacking. Absence of published prescription, tuning and general guidelines for use in Veterans with knee OA were also identified as limitations. This proposal has four aims: Aim 1) to develop a knee OA-specific tuning guide for KeeogoTM that would maximize user mobility activities with reduced pain across different levels of severity of knee OA; Aim 2) to examine the biomechanical responses of Veterans with knee OA to the active assistance provided by the Keeogo™ as compared with the passive assistance provided by standard knee braces; Aim 3) to evaluate in-laboratory mobility outcomes, pain perception, and user satisfaction with the KeeogoTM as compare with standard knee braces; and Aim 4) to develop recommendations for prescribing and tuning the use of knee OA exoskeleton devices. Aims 1 and 4 are development projects and no hypotheses are generated. The two hypotheses (H) to be tested for Aim 2 are: H2.1) in stance phase, walking with KeeogoTM will show less knee adduction moment (KAM), knee flexion moment (KFM), and muscle co-contraction than walking with standard knee braces. These variables have been shown to be related to internal joint loading as well as disease progression and pain; H2.2) in swing phase, walking with KeeogoTM will show greater knee range of motion (ROM), stride length, and foot clearance than walking with standard knee braces. These variables have been shown to be related to antalgic gait as a result of knee pain. The two hypotheses to be tested for Aim 3 are: H3.1) to show improved performance outcomes on mobility tests, including a 6-minute walk test, timed up and go test, 13-step stair test, pick up penny from floor test, and the Short Physical Performance Battery (SPPB) when using the KeeogoTM as compared with their prescribed knee braces and H3.2) to show reduced pain with the KeeogoTM by the numeric pain rating scale (NPRS) as compared with their prescribed knee braces for the mobility tests. The study will be conducted at two VA medical centers. The knee OA-specific tuning protocol will be developed (Aim 1) and used in the in-laboratory evaluations (Aim 3) in 20 and 26 Veterans with knee OA, respectively, at the James J. Peters VA Medical Center, Bronx, NY. The biomechanical studies (Aim 2) will be conducted in 24 Veterans with knee OA at the VA Pittsburgh Health System-Human Engineering Research Laboratories, Pittsburgh, PA. The investigators from both sites will work together to write the prescription and tuning guidelines (Aim 4) for public use. Expected outcomes: The tuning guide will facilitate quicker fitting and parameter adjustment, the biomechanics studies are expected to identify underlying mechanisms of action during device use, the in-laboratory study is expected to demonstrate improved walking velocities, stair ascent/descent times, improved sit-to-stand, stand- to-sit, and object retrieval from the floor with reduced patient-reported pain; and the knee OA-specific prescription and tuning guidelines will be deliverable for public use.