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（莱亚）的个体经常经历他们的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。这种运动导致从远端假体部件到残肢的动态载荷传递效率低下，这可能导致严重的继发性后果，例如疼痛、步态偏差和限制移动性和自主性的不适。随着时间的推移，低效的载荷传递可能导致完好接头上的力升高，这可能导致更高的风险 和退行性疾病的发病率。在我们对动态活动过程中残肢-接受腔相互作用的复杂机制的理解方面存在很大的差距，这限制了改进假肢设计的能力。虽然已经进行了骨和假肢接受腔之间的相对运动的评估，目前几乎没有现有的数据动态，在体内残肢接受腔运动学。动态立体X射线（DSX）是当前唯一可用的技术，其可以在各种各样的功能运动期间实现亚毫米骨姿态（位置和取向）估计精度，但是当前的分析方法和工具通常依赖于主观输入并且极其耗时。DSX是一种用于可视化体内快速骨骼运动的3D成像技术。DSX将计算机断层扫描（CT）扫描得出的骨形态3D模型（需要生成受试者特定的股骨残端骨模型，以跟踪骨骼运动学）与双平面X射线视频的运动数据相结合，以创建在3D空间中移动的骨的高度准确的重新动画。它允许计算活动期间的关节角度和活动范围（ROM）。利用DSX，我们在该试点项目的2年目标是开发和验证 时间效率高的3D定量功能评估工具，以量化残肢和假肢接受腔之间的体内运动学，在6个自由度（DOF）的运动与经股截肢的个人。为了验证分析工具及其与TFA的相关性，我们将评估两种插座设计：传统封装插座和压缩/释放稳定（CRS）插座。为此，研究人员将致力于以下目标：（1）在6个运动自由度上，使用DSX量化动态活动期间残骨和假肢接受腔之间的相对运动;（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。为了实现这些目标，将随机分配5名患有TFA的受试者，开始研究时使用传统的封装式髋臼杯或装配式CRS髋臼杯。每名受试者将佩戴指定的插座在家使用4周。4周后，每例受试者使用第二个插座重复该过程。在每个家庭使用阶段后，将对受试者进行Trinity截肢和假体经验量表（TAPES）满意度量表以及从假体评价问卷（PEQ）和截肢者假体概况（PPA）中提取的与接受腔舒适度和适配性相关的项目。此外，定性评估将通过半指导式访谈进行。在家庭使用8周后，每例受试者将被运送至普罗维登斯，罗得岛（布朗大学），在那里进行CT扫描，并使用DSX记录以自选速度行走、快速行走（快10%）和突然停止时的动态X射线序列。步态和运动数据将在每个动态任务期间与XROMM同时收集。通过开发用于残肢-接受腔运动的高度准确的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，以增强假体适合性，从而有可能减少继发性身体合并症和退行性变化，这些并发症是由假体负荷传递不良引起的。