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

 描述(由申请人提供)： 下肢截肢(LEA)患者通常会经历残肢和假肢承窝之间的相对运动，如垂直平移和轴向旋转。这种运动会导致从远端假体部件到残肢的动态载荷传递效率低下，这可能会导致严重的次要后果，如疼痛、步态偏差和限制行动能力和自主性的不适。随着时间的推移，低效的载荷传递可能会导致完整关节上的力升高，从而导致更高的风险。 和退行性疾病的发病率。在限制假体设计改进能力的动态活动中，我们对残肢-窝相互作用的复杂机制的理解有很大的差距。虽然已经对骨骼和假肢窝之间的相对运动进行了评估，但目前几乎没有关于动态的活体残肢-窝运动学的现有数据。动态体视X射线(Dynamic Stereo X-ray，简称DSX)是目前唯一能在多种功能运动中达到亚毫米级骨位姿(位置和方位)估计精度的技术，但目前的分析方法和工具往往依赖于主观输入，而且非常耗时。DSX是一种3D成像技术，用于可视化活体中的快速骨骼运动。DSX将从计算机断层扫描(CT)扫描获得的骨骼形态的3D模型(生成用于跟踪骨骼运动学的特定于受试者的剩余股骨骨骼模型)与来自双平面X射线视频的运动数据相结合，以创建骨骼在3D空间中移动的高精度重新动画。它允许在活动过程中计算关节角度和活动范围(ROM)。利用DSX，我们这个试点项目的两年目标是开发和验证 时间效率高的3D定量功能评估工具，用于量化残肢和假体承窝之间的活体运动学，在6个自由度(DOF)的运动中，接受经股截肢的患者。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：传统的封装式插座和压缩/释放稳定(CRS)插座。为此，研究人员将致力于以下目标：(1)使用DSX在6个运动自由度下量化动态活动期间残骨和假肢插座之间的相对运动；(2)比较两种下肢插座设计的舒适性、生活质量、满意度、感知稳定性和易用性。为了达到这些目标，将随机分配5名患有TFA的受试者，让他们使用传统的、封装的插座或制作的CRS插座开始研究。每个受试者将佩戴指定的插座，在家中使用4周。4周后，每个受试者将使用第二个插座重复这一过程。在每次家庭使用后，受试者将接受三位一体截肢和假体体验量表(Tapes)满意度量表，以及从假体评估问卷(PEQ)和截肢者假体轮廓(PPA)中提取的与插口舒适度和适合性相关的项目。此外，定性评估将通过半引导式面谈进行。在8周的家庭使用后，每个受试者将被运送到罗德岛普罗维登斯(布朗大学)，在那里将进行CT扫描，并使用DSX记录以自己选择的速度行走、快走(快10%)和突然停止时的动态X射线序列。在每个动态任务期间，将使用XROMM同时收集步态和运动数据。通过开发高精度在体评估残馀肢体-关节窝运动的分析工具，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来增强假体适合性，这些方法和技术有可能减少因假体负荷传递不良的并发症而导致的继发性物理并发症和退行性变化。

 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.