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.

膝关节骨关节炎（OA）是一个日益严重的问题，这是由于寿命增加和肥胖，估计为1400万 患有这种障碍的人。膝盖OA导致活动和生活方式的变化减少，进一步 加剧个人的健康。外骨骼技术（Keeogo™，B-Temia，Inc。）可能是可行的替代方案 通过提供动力支撑以减轻活动期间的疼痛来进行标准的膝盖OA治疗。初步的 使用Keeogo™在六人膝盖OA中进行的研究表明，在不同 移动性任务。但是，一项调整指南，以促进具有膝盖OA的临床医生和退伍军人更好的可用性， 有关设备如何提供积极帮助的生物力学的知识，以及实验室内评估 与标准的膝盖括号相比，缺乏性能结果。没有出版的处方， 在具有膝盖OA的退伍军人中使用的调整和一般指南也被确定为局限性。 该提议有四个目标：目标1）为Keeogotm制定膝盖OA特定的调整指南 在不同程度的膝盖OA严重程度下疼痛减轻疼痛，最大化用户移动活动；目标2） 检查带有膝盖OA的退伍军人对Keeogo™提供的积极帮助的生物力学反应 与标准膝盖括号提供的被动援助相比；目的3）评估定位的 与标准膝关节相比，机动性结果，疼痛感和用户满意度 牙套；目标4）开发出处方和调整膝关节外骨骼的建议 设备。目标1和4是开发项目，没有产生任何假设。两个假设（h）为 AIM 2测试为：H2.1）在立场阶段，与Keeogotm一起行走将显示较少的膝盖添加力矩 （KAM），膝盖屈曲力矩（肯德基）和肌肉共同收缩，而不是带有标准的膝盖牙套。这些 已显示变量与内部关节负荷以及疾病进展和疼痛有关。 H2.2） 在挥杆阶段，与基奥格姆一起行走将显示出更大的膝盖运动范围（ROM），步幅长度和脚 间隙比带有标准膝盖的牙套行走。这些变量已被证明与静态步态有关 由于膝盖疼痛。 AIM 3要测试的两个假设是：H3.1）表现出改进的性能 移动性测试的结果，包括6分钟的步行测试，计时和进行进行测试，13步楼梯测试，拿起Penny 与地板测试以及使用Keeogotm相比，使用keeogotm时的短体性能电池（SPPB） 他们处方的膝盖牙套和H3.2）通过数字疼痛等级显示keeogotm的疼痛减轻 （NPRS）与其规定的膝盖牙套进行移动测试相比。 该研究将在两个VA医疗中心进行。将制定膝盖OA特定的调整协议 （AIM 1），并在20和26名退伍军人的膝盖OA中用于实验室内评估（AIM 3） 纽约州布朗克斯市的詹姆斯·J·彼得斯医学中心。生物力学研究（AIM 2）将在24中进行 VA匹兹堡卫生系统人类工程研究实验室的退伍军人，膝盖OA 宾夕法尼亚州匹兹堡。来自两个站点的调查人员将共同努力编写处方和调整 指南（AIM 4）供公众使用。 预期结果：调整指南将促进更快的拟合和参数调整，生物力学 期望研究在设备使用过程中确定基本的作用机理，实验室内的研究IS 预计将表现出改善的步行速度，雄鹿上升/下降时间，改善的静止状态，独立 待办事项，并从地板上检索出患者报告的疼痛；和膝盖特异性 处方和调整指南将供公众使用。