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，原因是寿命延长和肥胖，估计有1400万人 生活在这种损伤中的人。膝骨性关节炎导致活动量减少和生活方式改变，进一步 使个人的健康恶化。外骨骼技术(Keeogo™，B-Tia，Inc.)可能是一个可行的选择 通过提供动力支持来减少活动时的疼痛，从而达到标准的膝骨性关节炎治疗。初步 在6名膝骨性关节炎患者中使用Keeogo™的研究显示，在不同的时间段，Keeogo对减轻疼痛有效果 移动任务。然而，一个调整指南，以促进更好的可用性的临床医生和退伍军人膝盖骨关节炎， 了解该设备如何提供主动辅助的生物力学知识，并进行实验室评估 与标准的膝盖支架相比，缺乏更多的性能结果。没有已公布的处方， 退伍军人膝骨性关节炎的调整和一般使用指南也被认为是限制因素。 这项建议有四个目标：目标1)为KeeogoTM开发特定于膝关节骨关节炎的调整指南，该指南将 最大限度地提高用户的活动能力，同时减少不同程度膝盖骨关节炎的疼痛；目标2) 检测退伍军人膝骨性关节炎患者对Keeogo™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；目的3)在实验室内进行评估 与标准膝关节相比，KeeogoTM的活动效果、疼痛感受和用户满意度 支具；以及目标4)为处方和调整膝关节骨关节炎外骨骼的使用制定建议 设备。目标1和目标4是发展项目，不会产生任何假设。两个假设(H)是 测试的目标2是：H2.1)在站立阶段，使用KeeogoTM行走将显示较少的膝关节内收力矩 (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)、步长和脚 比起穿着标准的护膝行走更安全。这些变量已被证明与止痛步态有关 这是膝盖疼痛的结果。要为目标3测试的两个假设是：H3.1)以显示改进的性能 行动能力测试的结果，包括6分钟步行测试，计时起跑测试，13级楼梯测试，捡起便士 从地面测试和使用KeeogoTM时的短物理性能电池(SPPB)与 他们的处方膝关节支架和H3.2)，以通过数字疼痛分级标准显示KeeogoTM的疼痛减轻 (NPR)与他们在活动能力测试中指定的膝盖支撑进行比较。 这项研究将在退伍军人管理局的两个医疗中心进行。将开发特定于膝盖骨关节炎的调谐协议 (AIM 1)，并用于实验室内评估(AIM 3)，分别用于20和26名退伍军人膝骨性关节炎患者，在 詹姆斯·J·彼得斯退伍军人医疗中心，纽约布朗克斯。生物力学研究(目标2)将在24年进行。 弗吉尼亚州匹兹堡卫生系统-人类工程研究实验室的退伍军人患有膝骨性关节炎， 宾夕法尼亚州匹兹堡来自两个站点的调查人员将共同撰写处方和调整 指导方针(目标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 这项实验室研究预计将确定设备使用过程中潜在的作用机制 预计将表现出更好的步行速度、楼梯上升/下降时间、坐-立、站立- 坐姿和从地板上取回物体，减少了患者报告的疼痛；以及特定于膝盖骨关节炎 处方和调整指南将提供给公众使用。