Identification of New Biomarkers for Determining Risk of Lower Extremity Fracture during Exoskeleton-assisted Ambulation: Developing a Personal Rehabilitation Approach to Optimize Function after SCI

鉴定用于确定外骨骼辅助行走期间下肢骨折风险的新生物标志物：开发个人康复方法以优化 SCI 后的功能

• 批准号: 10507770
• 负责人: NOAM Y. HAREL
• 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: 2021-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10507770
• 关键词: 3-Dimensional; Acceleration; Acute; Biological Markers; Bionics; Body Composition; Bone Density; Chronic; Clinical; Community Integration; Competence; Complex; Computer Models; Computing Methodologies; Data; Development; Devices; Distal; Distant; Dual-Energy X-Ray Absorptiometry; Electromyography; Elements; Eligibility Determination; Exclusion; Femur; Fracture; Future; Geometry; Goals; Hip Joint; Hip region structure; Image; Immobilization; Incidence; Individual; Injury; Insurance; Joints; Knee; Knee joint; Knowledge; Laboratories; Lead; Leg; Lesion; Literature; Lower Extremity; Lower Extremity Fracture; Manuals; Measurement; Mechanical Stress; Mechanics; Medical Care Costs; Medical center; Metabolism; Methods; Minerals; Modeling; Morbidity - disease rate; Motion; Motor; Muscle; Musculoskeletal; New Jersey; Outcome; Participant; Pathologic; Pathological fracture; Pathway interactions; Patients; Peripheral; Persons; Population; Positioning Attribute; Privatization; Property; Psychology; Publications; Quality of life; Reaction; Rehabilitation therapy; Reporting; Research; Research Personnel; Risk; Robotics; Roentgen Rays; Scanning; Selection Criteria; Series; Site; Spinal cord injury; Technology; Time; Torque; Training; United States; United States Department of Veterans Affairs; Veterans; Walking; Weight-Bearing state; Wheelchairs; Work; X-Ray Computed Tomography; ankle joint; bone; bone epiphysis; bone health; bone loss; calcaneum; cost; eligible participant; evidence base; exoskeleton; exoskeleton device; foot; fracture risk; fragility fracture; high risk; human model; human-robot interaction; image processing; improved; improved mobility; insight; interest; long bone; novel; prevent; radiological imaging; recruit; risk minimization; risk prediction; robot exoskeleton; robotic device; simulation; standard care; tibia

Persons with acute SCI have rapid and progressive sublesional bone loss, with up to 73% bone at the epiphyses resorbed within the first few years after injury, placing them at high risk of fragility fractures and post- fracture complications. It is estimated that 70-76% of persons with spinal cord injury (SCI) will sustain a low- impact, or pathologic, fracture during their lifetime. Over 80% of fragility fractures occur in the lower extremities, with the most common fracture site being the knee region (e.g., distal femur and proximal tibia). Pathological fractures and post-fracture complications lead to patient morbidity and substantial cost. Robotic exoskeletons will become a viable option for routine mobility for people with SCI. The Department of Veterans Affairs has already committed to providing an exoskeleton to every eligible Veteran with SCI who wants one, and it is only a matter of time before private insurance companies include robotic exoskeletons for ambulation as a component of standard care, likely accelerating the general popularity of such devices. The question that may be raised is what is the optimal clinical approach to accurately predict the risk of fracture in persons with SCI prior to prescribing an exoskeletal-assisted walking (EAW) device? Although substantial improvements in body composition, metabolism, psychology, and overall quality of life have been observed with EAW use, exoskeletons place an already vulnerable SCI population at an even greater risk of fracture. Fractures in persons with SCI during EAW have been reported, with incidence ranging from 7.1% to 10.0%. Thus, it is plausible to speculate that if less stringent criteria are employed for the clinical prescription of exoskeleton devices when their use becomes more widespread that the incidence of fracture will be higher. The ability to predict which persons with SCI are at highest risk for fracture during EAW will allow appropriate and preemptive approaches to minimize the occurrence of fractures and to maximize participant eligibility. Building on prior work, the proposed study will provide a scientific rationale for evidence-based thresholds for prescribing EAW in Veterans. The proposed study will develop new evidence-based biomarkers to identify persons with SCI at highest risk of long-bone and/or calcaneus fractures when participating in upright rehabilitation activities. The ability to predict which persons with SCI are at highest risk for fracture during EAW will allow evidence-based approaches to minimize fractures and associated morbidity, as well as prevent avoidable medical costs. The Aims of this work are: (1) to determine biomarkers of bone health in persons with SCI from subject- specific finite element (FE) models from a wide range of bone densities at the hip, knee, and calcaneus; (2) to determine the forces at the hip, knee, and ankle joints of persons with SCI during exoskeleton-assisted sit-to- stand and stand-to-sit; and (3) to determine the forces at the hip, knee, and ankle joints of persons with SCI during EAW. Our partnerships with ReWalk Robotics, Parker Hannifin, and Ekso Bionics will provide the investigators with access to proprietary motor torque data, enabling us to build accurate musculoskeletal models of human-robot interaction. Forty-five (45) participants with SCI and 10 able-bodied (AB) controls will be recruited for dual x-ray absorptiometry (DXA), peripheral quantitative computed tomography (pQCT), and computed tomography (CT) that will be performed at the James J. Peters Veterans Affairs Medical Center (JJP VAMC). Training in the devices will be performed at the JJP VAMC. The computational models and FE-based biomarkers will be developed, and the motion capture analyses of exoskeletal maneuvers, will be performed at the New Jersey Institute of Technology. While in the each of the three exoskeletal devices (ReWalk, Ekso, and Indego), the forces at the hip, knee, and ankle joints will be quantified in conjunction with motion analysis during sit-to- stand maneuvers (in 19 SCI and 7 AB controls) and during EAW (In 10 SCI and 4 AB controls). Subject-specific FE models with hip, knee, and ankle joint forces will be developed to quantify mechanical stress/strain during EAW and correlated to FE-based biomarkers. Novel insights into human-robot interaction should be obtained.

患有急性SCI的人具有快速和进行性的骨骼损失，骨头高达73％ 受伤后的头几年，epiphyses在脆弱性骨折和后的高风险中被吸引 断裂并发症。据估计，有70-76％的脊髓损伤患者（SCI）将维持低 - 撞击或病理性骨折一生。超过80％的脆性骨折发生在下肢， 最常见的断裂部位是膝盖区域（例如股骨远端和胫骨近端）。病理 骨折和骨折后并发症会导致患者发病率和大量成本。 机器人外骨骼将成为SCI患者常规移动性的可行选择。部门 退伍军人事务已经致力于为每位有资格的退伍军人提供外骨骼，SCI 想要一个 作为标准护理的组成部分，行动可能会加速此类设备的总体受欢迎程度。这 可能提出的问题是准确预测骨折风险的最佳临床方法 在开处方外骨骼辅助步行（EAW）设备之前，患有SCI的人？虽然很重要 已经观察到身体成分，新陈代谢，心理学和整体生活质量的改善 EAW使用，外骨骼将已经脆弱的SCI人群置于更大的骨折风险。断裂 据报道，在EAW期间患有SCI的人，发病率从7.1％到10.0％不等。因此，是 可以推测，如果使用较少严格的标准用于外骨骼的临床处方 当设备的使用变得更加普遍时，裂缝的发生率会更高。能力 预测哪些SCI患者在EAW期间有骨折的风险最高 最小化骨折的发生并最大化参与者资格的方法。在先前工作的基础上 拟议的研究将为开处方EAW的循证阈值提供科学理由 退伍军人。拟议的研究将开发新的基于证据的生物标志物，以识别患有SCI的人 参加直立康复活动时，长骨和/或钙骨骨折的最高风险。这 能够预测哪些SCI患者在EAW期间骨折的风险最高，将允许基于证据 减少骨折和相关发病率的方法，并防止可避免的医疗费用。 这项工作的目的是：（1）确定受试者SCI患者的骨骼健康生物标志物 - 来自髋关节，膝盖和钙的特定有限元（Fe）模型。 （2）至 确定外骨骼辅助坐姿的髋关节，膝盖和脚踝关节的SCI人的脚踝关节 站立和站立； （3）确定SCI患者的臀部，膝盖和踝关节的力 在EAW期间。我们与Rewalk Robotics，Parker Hannifin和Ekso Bionics的合作伙伴关系将提供 可以访问专有电动机扭矩数据的研究人员，使我们能够构建准确的肌肉骨骼模型 人类机器人相互作用。将招募有SCI和10个健美（AB）控制的45（45）名参与者 用于双X射线吸收法（DXA），外围定量计算机断层扫描（PQCT）和计算 将在James J. Peters退伍军人事务医疗中心（JJP VAMC）上进行的断层扫描（CT）。 设备的培训将在JJP VAMC进行。计算模型和基于FE的生物标志物 将开发，并将在新的 泽西技术学院。而在三个外骨骼设备中的每一个（Rewalk，Ekso和Indego）中， 臀部，膝盖和脚踝关节的力将与坐姿分析一起定量 站立动作（在19个SCI和7个AB对照中）和EAW期间（在10个SCI和4个AB对照中）。特定于主题 将开发带有髋关节，膝盖和踝关节力的Fe模型，以量化机械应力/应变。 EAW并与基于FE的生物标志物相关。应获得对人类机器人相互作用的新见解。