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: 10314390
• 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/10314390
• 关键词: 3-Dimensional; 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; Femur; Fracture; Future; Geometry; Goals; Hip Joint; Hip region structure; Image; Immobilization; Incidence; Individual; Injury; Institutes; 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; 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; Torsion; Training; United States; United States Department of Veterans Affairs; Veterans; Walking; Weight-Bearing state; Wheelchairs; Work; X-Ray Computed Tomography; ankle joint; base; bone; bone epiphysis; bone health; bone loss; calcaneum; cost; 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; 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.

急性脊髓损伤患者的病灶下骨丢失迅速且进行性， 骨骺在受伤后的最初几年内吸收，使其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）患者将持续低- 撞击性或病理性骨折。超过80%的脆性骨折发生在下肢， 最常见的骨折部位是膝盖区域（例如，股骨远端和胫骨近端）。病理 骨折和骨折后并发症导致患者发病率和大量费用。 机器人外骨骼将成为SCI患者日常移动的可行选择。部 退伍军人事务部已经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，这只是一个时间问题，私人保险公司包括机器人外骨骼， 这可能会加速此类设备的普遍普及。的 可能会提出的问题是，什么是准确预测骨折风险的最佳临床方法， SCI患者在处方外骨骼辅助行走（EAW）设备之前？虽然数量可观， 在身体组成，新陈代谢，心理和整体生活质量的改善已被观察到， EAW的使用，外骨骼使已经脆弱的SCI人群面临更大的骨折风险。骨折 据报道，在EAW期间发生SCI的患者中，发病率范围为7.1%至10.0%。照经上所 合理地推测，如果外骨骼的临床处方采用不太严格的标准， 当器械的使用变得更广泛时，断裂的发生率将更高。的能力 预测哪些SCI患者在EAW期间骨折风险最高， 最大限度地减少骨折发生率并最大限度地提高参与者资格的方法。在先前工作的基础上， 拟议的研究将为EAW处方的循证阈值提供科学依据， 老兵这项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。的 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的 最大限度地减少骨折和相关发病率的方法，以及防止可避免的医疗费用。 这项工作的目的是：（1）确定SCI患者骨健康的生物标志物， 来自髋关节、膝关节和跟骨广泛骨密度的特定有限元（FE）模型;（2） 在外骨骼辅助坐立期间，确定SCI患者髋关节、膝关节和踝关节处的力， 站立和站立到坐下;（3）确定SCI患者髋关节、膝关节和踝关节的力 在EAW期间。我们与ReWalk Robotics、帕克Hannifin和Ekso Bionics的合作伙伴关系将提供 研究人员可以访问专有的运动扭矩数据，使我们能够建立准确的肌肉骨骼模型 人机互动的方式。将招募45名SCI受试者和10名健全（AB）对照受试者 双能X线吸收测定法（DXA）、外周定量计算机断层扫描（pQCT）和计算机 将在James J. Peters Veterans Affairs Medical Center（JJP VAMC）进行断层扫描（CT）。 设备培训将在JJP VAMC进行。计算模型和基于FE的生物标志物 将开发，外骨骼机动的运动捕捉分析，将在新的 新泽西理工学院.而在三种外骨骼设备（ReWalk、Ekso和Indego）中的每一种中， 髋关节、膝关节和踝关节处的力将结合坐立期间的运动分析进行量化， 站立动作（19例SCI和7例AB对照）和EAW期间（10例SCI和4例AB对照）。对象特定 将开发具有髋关节、膝关节和踝关节力的FE模型，以量化在 EAW与基于FE的生物标志物相关。应该获得对人机交互的新见解。