Effect of Prosthetic Socket Design on Residual Limb Motion using Biplane X-Ray Video

使用双平面 X 射线视频研究假肢接受腔设计对残肢运动的影响

• 批准号: 9920006
• 负责人: Jason Maikos
• 金额: --
• 依托单位: VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9920006
• 关键词: 3-Dimensional; Address; Algorithms; Amputation; Amputees; Articular Range of Motion; Assessment tool; Biomechanics; Clinical; Complex; Consumption; Data; Degenerative Disorder; Development; Distal; Encapsulated; Evaluation; Femur; Fluoroscopy; Foundations; Freedom; Gait; Goals; Guidelines; Home environment; Imaging Techniques; Imaging technology; Incidence; Individual; Interview; Investigation; Joints; Lead; Limb Prosthesis; Lower Extremity; Measurement; Mechanics; Methods; Modeling; Morphology; Motion; Movement; Outcome Measure; Pain; Participant; Patients; Pilot Projects; Positioning Attribute; Process; Prosthesis; Prosthesis Design; Protocols documentation; Quality of life; Questionnaires; Randomized; Research Personnel; Residual state; Rhode Island; Roentgen Rays; Rotation; Scanning; Secure; Skin; Speed; Surface; Surveys; System; Tantalum; Techniques; Technology; Testing; Three-Dimensional Imaging; Time; Translations; Universities; Walking; X-Ray Computed Tomography; analytical method; analytical tool; animation; base; bone; bone prosthesis; clinical practice; comorbidity; evidence base; experience; high risk; improved; in vivo; kinematics; limb amputation; limb movement; prosthetic socket; public health relevance; residual limb; satisfaction; skeletal; skeletal movement; skin ulcer; socket design; three-dimensional modeling; transmission process

 DESCRIPTION (provided by applicant): Individuals living with a lower extremity amputation (LEA) often experience relative motion between their residual limb and the prosthetic socket, such as vertical translation and axial rotation. This motion causes inefficient dynamic load transmission from the distal prosthetic components to the residual limb, which can lead to significant secondary consequences, such as pain, gait deviations, and discomfort that limit mobility and autonomy. Over time, inefficient load transmission can lead to elevated forces on the intact joints, which can result in higher risk and incidences of degenerative diseases. There is a substantial gap in our understanding of the complex mechanics of the residual limb-socket interaction during dynamic activities that limit the ability to improve prosthetic design. Although assessments of the relative motion between the bone and the prosthetic socket have been performed, currently there is little existing data on dynamic, in vivo residual limb-socket kinematics. Dynamic Stereo X-ray (DSX) is the only currently available technology that can achieve sub- millimeter bone pose (position and orientation) estimation accuracy during a wide variety of functional movements, but current analytical methods and tools often rely on subjective input and are extremely time consuming. DSX is a 3D imaging technology for visualizing rapid skeletal movement in vivo. DSX combines 3D models of bone morphology derived from computed tomography (CT) scans (required to generate the subject specific bone models of the remnant femur for tracking skeletal kinematics) with movement data from biplanar x-ray video to create highly accurate re-animations of the bone moving in 3D space. It allows for the calculation of joint angles and range of motion (ROM) during activity. Utilizing DSX, our 2 year goals for this pilot project are to develop and validate time-efficient 3D quantitative functional assessment tools to quantify the in vivo kinematics between the residual limb and prosthetic socket, in 6 degrees of freedom (DOF) of motion for individuals with transfemoral amputation. To verify the analytical tools and their relevance to TFA, we will evaluate two socket designs: a traditional encapsulated socket and a Compression/Release Stabilization (CRS) socket. To do so, the investigators will address the following aims: (1) To quantify, in 6 degrees of freedom of motion, the relative motion between the residual bone and the prosthetic socket during dynamic activities using DSX; (2) To compare comfort, quality of life, satisfaction, perceived stability, and ease of use of two lower limb socket designs. To address these aims, 5 subjects with TFA will be randomly assigned to start the study with their traditional, encapsulated socket or a fabricated CRS socket. Each subject will wear the assigned socket for 4 weeks of home use. After 4 weeks, the process will be repeated with each subject utilizing the second socket. After each period of home use, subjects will be administered the Trinity Amputations and Prosthetics Experience Scale (TAPES) satisfaction scale, and items related to socket comfort and fit drawn from both the Prosthetic Evaluation Questionnaire (PEQ) and Prosthetic Profile of the Amputee (PPA). Furthermore, a qualitative assessment will be performed through semi-guided interview. Following 8 weeks of home use, each subject will then be transported to Providence, Rhode Island (Brown University), where a CT scan will be performed and DSX will be utilized to record dynamic X-ray sequences during walking at self-selected speed, fast walking (10% faster), and sudden stop. Gait and movement data will be collected simultaneously with the XROMM during each dynamic task. By developing the analytical tools for a highly accurate in-vivo assessment of residual limb-socket motion, we can provide vital foundational information to aid in the development of new methods and techniques to enhance prosthetic fit that have the potential to reduce secondary physical comorbidities and degenerative changes that result from complications of poor prosthetic load transmission.

 描述（由申请人提供）： 患有下肢截肢（LEA）的人通常会在残留的肢体和假肢插座（例如垂直翻译和轴向旋转）之间经历相对运动。这种运动导致从不同的假体成分到残留肢体的动态负载效率低下，这可能导致重大的次要后果，例如疼痛，步态出发和限制移动性和自主权的不适感。随着时间的流逝，负载效率低下会导致完整接头上的升高力，这可能导致较高的风险 和退化性疾病的发明。在动态活动期间，我们对残留肢体相互作用的复杂机制的理解存在很大的差距，这限制了改善假体设计的能力。尽管已经进行了对骨骼和假体插座之间的相对运动的评估，但目前几乎没有关于动态，体内残留肢体插槽运动学的现有数据。动态立体X射线（DSX）是唯一可以在各种功能运动中实现亚毫米骨姿势（位置和方向）估计精度的唯一一项技术，但是当前的分析方法和工具通常依赖于主题输入并且非常耗时。 DSX是一种3D成像技术，可在体内可视化快速骨骼运动。 DSX结合了源自计算机断层扫描（CT）扫描的骨形态的3D模型（需要生成用于跟踪骨骼运动学的残余股骨的特定主题骨模型）以及Biplanar X射线视频的移动数据，以创建高度准确的骨骼在3D空间中移动的骨骼。它允许在活动过程中计算关节角度和运动范围（ROM）。利用DSX，我们为该试点项目的2年目标是开发和验证 时间效率的3D定量功能评估工具，可量化残留肢体和假体插座之间的体内运动学，以6个自由度（DOF）的运动（DOF）运动（DOF），用于具有跨性截肢的人。为了验证分析工具及其与TFA的相关性，我们将评估两个插座设计：传统的封装套接字和压缩/释放稳定（CRS）插座。为此，研究人员将解决以下目的：（1）在6个运动自由度下，使用DSX量化残留骨和假体插座之间的相对运动； （2）比较舒适性，生活质量，满意度，可感知的稳定性以及两个下肢插座设计的易用性。为了解决这些目标，将随机分配5个具有TFA的受试者，以使用传统的，封装的插座或制造的CRS插座开始研究。每个受试者都会佩戴分配的插座，以持续4周的家庭使用。 4周后，将对每个受试者使用第二个插座重复该过程。在每个家庭使用期间之后，将对受试者进行三位一体截肢和假肢经验量表（磁带）满意度量表，以及与插座舒适度相关的项目，并从假肢评估问卷（PEQ）（PEQ）和截肢者（PPA）的假体概况中得出。此外，将通过半导体采访进行定性评估。在家使用8周后，每个受试者将被运送到罗德岛（布朗大学）的普罗维登斯，在那里将进行CT扫描，并在以自选择的速度行走，快速步行（快10％）的情况下，将DSX用于记录动态X射线序列，并突然停止。在每个动态任务期间，将使用Xromm来收集步态和运动数据。通过开发分析工具，以对残留肢体插座运动进行高度准确的体内评估，我们可以提供重要的基础信息，以帮助开发新方法和技术，以增强假体合并症的潜力，从而减少次要物理合并症和由于较差的假装负载传播的并发症而导致的变化。