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.

急性 SCI 患者会出现快速且进行性的病灶下骨质流失，高达 73% 的骨质流失 骨骺在受伤后的最初几年内吸收，使它们处于脆性骨折和术后骨折的高风险中。 骨折并发症。据估计，70-76% 的脊髓损伤 (SCI) 患者将持续处于低水平状态 在其一生中发生冲击或病理性骨折。 80%以上的脆性骨折发生在下肢， 最常见的骨折部位是膝关节区域（例如股骨远端和胫骨近端）。病理性的 骨折和骨折后并发症导致患者发病并产生大量费用。 机器人外骨骼将成为 SCI 患者日常活动的可行选择。部门 退伍军人事务部已承诺为每一位符合条件的 SCI 退伍军人提供外骨骼， 想要一个，私人保险公司为客户提供机器人外骨骼只是时间问题 移动作为标准护理的一部分，可能会加速此类设备的普遍普及。这 可能提出的问题是准确预测骨折风险的最佳临床方法是什么？ 患有 SCI 的人在使用外骨骼辅助行走 (EAW) 装置之前？虽然实质性 观察到身体成分、新陈代谢、心理和整体生活质量的改善 使用 EAW 外骨骼使本已脆弱的 SCI 人群面临更大的骨折风险。骨折 据报道，EAW 期间发生 SCI 的患者中发生 SCI 的几率为 7.1% 至 10.0%。因此，它是 可以推测，如果外骨骼的临床处方采用不太严格的标准 当设备的使用变得更加广泛时，骨折的发生率就会更高。有能力 预测哪些 SCI 患者在 EAW 期间骨折风险最高，将允许采取适当和先发制人的措施 最大限度地减少骨折发生并最大限度地提高参与者资格的方法。在之前的工作基础上， 拟议的研究将为 EAW 处方的循证阈值提供科学依据 退伍军人。拟议的研究将开发新的循证生物标志物，以识别 SCI 患者 参加直立康复活动时，长骨和/或跟骨骨折的风险最高。这 预测哪些 SCI 患者在 EAW 期间骨折风险最高的能力将允许基于证据 最大限度地减少骨折和相关发病率并防止可避免的医疗费用的方法。 这项工作的目的是：(1) 确定 SCI 患者骨骼健康的生物标志物—— 来自髋部、膝部和跟骨的各种骨密度的特定有限元 (FE) 模型； (2) 至 确定 SCI 患者在外骨骼辅助坐姿过程中髋关节、膝关节和踝关节处的力 站着和站着坐； (3) 确定 SCI 患者髋关节、膝关节和踝关节的受力 EAW期间。我们与 ReWalk Robotics、Parker Hannifin 和 Ekso Bionics 的合作伙伴关系将提供 研究人员可以获得专有的电机扭矩数据，使我们能够建立准确的肌肉骨骼模型 人机交互。将招募四十五 (45) 名 SCI 参与者和 10 名健全 (AB) 对照 用于双 X 射线吸收测定法 (DXA)、外周定量计算机断层扫描 (pQCT) 和计算机断层扫描 断层扫描 (CT) 将在 James J. Peters 退伍军人事务医疗中心 (JJP VAMC) 进行。 设备培训将在 JJP VAMC 进行。计算模型和基于有限元的生物标志物 将被开发，并且外骨骼操作的运动捕捉分析将在新的 泽西理工学院。在三种外骨骼设备（ReWalk、Ekso 和 Indego）中， 髋关节、膝关节和踝关节的受力将结合坐姿到运动过程中的运动分析进行量化 站立机动（在 19 SCI 和 7 AB 控制中）和 EAW 期间（在 10 SCI 和 4 AB 控制中）。特定主题 将开发具有髋关节、膝关节和踝关节力的有限元模型，以量化过程中的机械应力/应变 EAW 并与基于 FE 的生物标志物相关。应该获得关于人机交互的新见解。