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

针对患有膝骨关节炎的退伍军人的膝关节应力消除动力外骨骼的设计改进和评估

• 批准号: 10574518
• 负责人: Dan Ding
• 金额: --
• 依托单位: JAMES J PETERS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10574518
• 关键词: Activities of Daily Living; Address; Adult; Age; Analgesics; Articular Range of Motion; Biomechanics; Canada; Clinic; Clinical Trials; Degenerative polyarthritis; Development; Devices; Disease Progression; Evaluation; Floor; Gait; Guidelines; Health; Health system; Healthcare Systems; Human Engineering; Impairment; Individual; Intake; International; Interruption; Intervention; Knee; Knee Osteoarthritis; Knowledge; Laboratories; Laboratory Research; Laboratory Study; Length; Life Style; Longevity; Marketing; Mechanics; Medical; Medical center; Mental Depression; Military Personnel; Motor; Muscle; Obesity; Operative Surgical Procedures; Opioid; Outcome; Pain; Pain management; Participant; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Physical Performance; Physical activity; Physical therapy; Population; Protocols documentation; Publishing; Quality of life; Quebec; Questionnaires; Recommendation; Reporting; Research; Research Personnel; Retrieval; Sensory; Severities; Site; Socialization; Societies; Stress; Symptoms; System; Technology; Testing; United States; United States Department of Veterans Affairs; United States Food and Drug Administration; Veterans; Veterans Health Administration; Waiting Lists; Walking; Weight maintenance regimen; Work; Writing; active duty; addiction; adduct; combat; compare effectiveness; design; disability; exoskeleton; exoskeleton device; experience; foot; improved; improved mobility; injured; joint loading; knee pain; knee replacement arthroplasty; neurological rehabilitation; pain perception; pain reduction; powered exoskeleton; response; robot exoskeleton; satisfaction; trend; usability; walking speed; weight loss program

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.

由于寿命延长和肥胖，膝骨关节炎 (OA) 成为一个日益严重的问题，估计有 1,400 万人患有膝骨关节炎 (OA) 患有这种损伤的人会进一步导致活动减少和生活方式改变。 加剧个人健康状况的外骨骼技术（Keeogo™，B-temia，Inc.）可能是一种可行的替代方案。 通过提供动力支持来减轻初步活动期间的疼痛，以达到标准的膝关节 OA 治疗。 对 6 名膝关节 OA 患者进行的 Keeogo™ 研究表明，Keeogo™ 在不同时期可有效减轻疼痛。 然而，一个调整指南可以提高患有膝骨关节炎的殖民者和退伍军人的可用性， 有关设备如何提供主动帮助的生物力学知识以及实验室评估 与标准护膝相比，缺乏公开的处方， 对于患有膝骨关节炎的退伍军人来说，调整和一般指南也被认为是其局限性。 该提案有四个目标： 目标 1) 为 KeeogoTM 开发膝关节 OA 特定调整指南，该指南将 最大限度地提高用户的活动能力，减少不同严重程度的膝关节 OA 的疼痛 目标 2)； 检查患有膝骨关节炎的退伍军人对 Keeogo™ 提供的主动帮助的生物力学反应 与标准护膝提供的被动辅助进行比较；目标 3) 进行实验室评估 与标准膝关节相比，KeeogoTM 的活动结果、疼痛感知和用户满意度 目标 4) 制定膝关节骨关节炎外骨骼的处方和调整建议 目标 1 和 4 是开发项目，没有生成任何假设 (H)。 目标 2 的测试为：H2.1) 在站立阶段，使用 KeeogoTM 行走将显示较少的膝盖附加力矩 (KAM)、膝关节屈曲力矩 (KFM) 和肌肉协同收缩与使用标准护膝行走相比。 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 行走将显示更大的膝盖运动范围 (ROM)、步幅长度和足部 与使用标准护膝行走相比，这些变量已被证明与镇痛步态有关。 目标 3 所要测试的两个假设是：H3.1) 以表现出改善的表现。 行动能力测试结果，包括 6 分钟步行测试、计时即走测试、13 步楼梯测试、捡起便士 地板测试，以及使用 KeeogoTM 时的短期物理性能电池 (SPPB) 与 他们规定的护膝和 H3.2) 通过数字疼痛评级表显示 KeeogoTM 减轻了疼痛 （NPRS）与他们为活动测试指定的护膝进行比较。 该研究将在两个 VA 医疗中心进行，并将制定针对膝关节 OA 的调整方案。 （目标 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）， 纽约布朗克斯 James J. Peters VA 医疗中心 生物力学研究（目标 2）将于 24 日进行。 退伍军人事务部匹兹堡卫生系统人类工程研究实验室患有膝骨关节炎的退伍军人， 来自宾夕法尼亚州匹兹堡的研究人员将共同制定处方和调整。 供公众使用的指南（目标 4）。 预期成果：调整指南将有助于更快地拟合和参数调整，生物力学 预计研究将确定设备使用过程中的潜在作用机制，实验室研究是 预计将展示步行速度、上下楼梯时间的改善、从坐到站、站立的改善 坐下，从地板上取回物体，减少患者报告的疼痛和膝骨关节炎的特异性； 处方和调整指南将可供公众使用。