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）： 下肢截肢 (LEA) 患者经常会经历残肢和假肢接受腔之间的相对运动，例如垂直平移和轴向旋转，这种运动会导致从远端假肢部件到残肢的动态负载传递效率低下。导致严重的次要后果，例如限制活动性和自主性的疼痛、步态偏差和不适。随着时间的推移，低效的负载传输可能会导致完好关节上的力增大，从而导致更高的风险。 尽管对骨骼和假肢承窝之间的相对运动进行了评估，但我们对动态活动期间残肢-承窝相互作用的复杂机制的理解存在很大差距。已经进行过，目前关于动态体内残肢窝运动学的现有数据很少，动态立体 X 射线（DSX）是目前唯一可以实现亚毫米骨姿势（位置和方向）的技术。 DSX 是一种用于可视化体内快速骨骼运动的 3D 成像技术，它结合了源自骨骼形态的 3D 模型。计算机断层扫描 (CT) 扫描（需要生成受试者特定的股骨残余骨模型，用于跟踪骨骼运动学）以及来自双平面 X 射线视频的运动数据，以创建高精度它允许在活动期间计算关节角度和运动范围 (ROM)，我们该试点项目的 2 年目标是开发和验证。 省时的 3D 定量功能评估工具，用于量化经股截肢患者的残肢和假肢接受腔之间的 6 自由度 (DOF) 体内运动学为了验证分析工具及其与 TFA 的相关性。将评估两种插槽设计：传统封装插槽和压缩/释放稳定 (CRS) 插槽 为此，研究人员将实现以下目标： (1) 以 6 个自由度进行量化。 (2) 比较两种下肢接受腔设计的舒适度、生活质量、满意度、感知稳定性和易用性。目标是，5 名患有 TFA 的受试者将被随机分配以使用传统的封装插座或制造的 CRS 插座开始研究，每位受试者将佩戴指定的插座在家使用 4 周。4 周后，将重复该过程。每个受试者使用第二个插座。在每次家庭使用后，受试者将接受 Trinity 截肢和假肢体验量表 (TAPES) 满意度量表，以及从假肢评估问卷 (PEQ) 和截肢者假肢概况 (PPA) 中抽取的与接受腔舒适度和贴合度相关的项目此外，在 8 周的家庭使用后，将通过半引导访谈进行定性评估，然后将每个受试者送往罗德岛州普罗维登斯（布朗大学），在那里进行 CT 扫描。 DSX 将用于记录以自选速度行走期间的动态 X 射线序列，快速行走（快 10%）以及在每个动态任务期间使用 XROMM 同时收集步态和运动数据。通过开发用于对残肢窝运动进行高精度体内评估的分析工具，我们可以提供重要的基础信息，以帮助开发新的方法和技术，以增强假肢的贴合性，从而有可能减少继发性身体合并症和退行性病变。由于假肢负荷传递不良的并发症而导致的变化。