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: 10396474
• 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/10396474
• 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; Lead; Length; Life Style; Longevity; 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; Time; United States; United States Department of Veterans Affairs; United States Food and Drug Administration; Veterans; Waiting Lists; Walking; Weight maintenance regimen; Work; Writing; active duty; addiction; combat; compare effectiveness; design; disability; exoskeleton; exoskeleton device; experience; foot; improved; improved mobility; injured; joint loading; knee pain; knee replacement arthroplasty; military veteran; 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，膝关节骨性关节炎（OA）是一个日益严重的问题，估计有1400万人