Interface Kinematics of Transhumeral Prosthetic Sockets using XROMM

描述（由申请人提供）： 背景资料：在过去的十年中，上肢接受腔设计和技术的进步已经被提出来增加假肢的舒适度和减少假肢的感知重量。优化DEKA机械臂的VA研究采用了一种这样的设计，即高保真关节窝界面，以增加DEKA假体的舒适性、稳定性和重量耐受性。然而，还没有进行研究来验证这些说法或将这种插座设计与更传统的设计进行比较。目的：本试验研究的目的是对两种候选插座设计进行头对头比较：传统TH插座设计和“高保真”插座设计。具体目标是：1）优化XROMM系统，以测量佩戴经肱骨假肢接受腔时的骨骼运动学; 2）比较两种上肢接受腔设计的舒适度、感知稳定性、感知假肢重量以及穿脱容易程度; 3）确定主动活动范围（ROM）、垂直载荷和抵抗活动期间的骨骼、关节和接受腔运动学。研究方法：将进行尸体研究，以检查XROMM系统的静态和动态准确性，并在用于研究的人类受试者部分之前完善运动跟踪和分析算法。两名经肱骨截肢的受试者将被随机分配到两组之一："传统接受腔"第一组或"高保真"接受腔第一组。每名受试者将安装适当的假肢接受腔，并将在家中使用该接受腔两周。在家庭使用第一个接受腔后，受试者将返回VA，以调查其假体的舒适性、稳定性、感知重量以及穿脱的容易性。该过程将在第二个插座设计中重复。将对调查结果进行定性比较。将使用XROMM以及传统光学运动捕捉来研究窝相对于远端剩余肱骨的运动。XROMM数据将在主动肩关节活动范围、高要求垂直载荷和抵抗活动期间生成。我们还将描述与基于皮肤标记的光学运动跟踪系统测量上肢运动相关的软组织运动伪影。使用这些技术，我们将检查：残余骨在窝内的运动、肢体周围软组织的轴向旋转、窝在肢体周围的轴向旋转、垂直载荷期间窝的滑动以及窝的平移：肢体周围界面的任何总体运动（不包括轴向旋转）。重要性：高保真上肢关节窝设计一直被提倡以改善舒适性、增加关节窝稳定性并改善负重活动期间的悬挂。然而，还没有进行研究来验证这些说法或将这种插座设计与更传统的设计进行比较。这项试点研究将使用主题调查，功能测试和先进的运动学分析来比较高保真和传统的插座设计。我们的研究将采用双平面视频放射摄影（XROMM）的尖端方法，以及使用XROMM作为动态骨骼运动测量的“金标准”来评估传统光学运动捕捉方法的能力和局限性。虽然已经进行了初步的研究，以检查接口的下肢假肢。双平面影像学尚未应用于上肢假肢适配性分析。这项试点研究将提供初步的数据，以指导决策上肢假肢接受腔处方为未来的VA研究先进的上肢假肢。

DESCRIPTION (provided by applicant): Background: In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. The VA Study to Optimize the DEKA Arm employs one such design, the high fidelity socket interface, to increase comfort, stability, and tolerance of the weight of the DEKA prosthesis. However, no research studies have been conducted to validate these claims or compare this socket design to a more traditional design. Objectives: The purpose of this pilot study is to conduct a head to head comparison of two candidate socket designs: the traditional TH socket design and the "high fidelity" socket design. The specific objectives are to: 1) optimize the XROMM system for the measurement of skeletal kinematics while wearing a transhumeral prosthetic socket, 2) compare comfort, perceived stability, perceived prosthetic weight, and ease of donning and doffing of two upper limb socket designs, and 3) determine bone, joint and sockets kinematics during active range of motion (ROM), vertical loading, and resisted activities. Methods: A cadaver study will be conducted to examine static and dynamic accuracy of the XROMM system, and to refine the motion tracking and analysis algorithms prior to use in the human subjects portion of the study. Two subjects with transhumeral amputation will be randomly assigned to one of two groups "traditional socket," first group or "high fidelity" socket first grop. Each subject will be fit with the appropriate prosthetic socket and will wear that socket for two weeks of home use. Following home usage of the first socket, the subject will return to the VA to be surveyed about comfort, stability, perceived weight of their prosthesis, and ease of donning and doffing. The process will be repeated with the second socket design. Survey results will be compared qualitatively. XROMM as well as conventional optical motion capture will be used to study the motion of the socket with respect to the distal residual humerus. XROMM data will be generated during active shoulder range of motion, high demand vertical loading, and resisted activities. We will also characterize soft tissue motion artifacts associated with measuring upper extremity motion with skin marker-based optical motion tracking systems. Using these techniques, we will examine: motion of residual bone within the socket, axial rotation of soft tissue around the limb, axial rotation of socket around the limb, slip of the socket during vertica loading, and translation of socket: any gross movement (excluding axial rotation) of the interface around the limb. Significance: The high fidelity upper limb socket design has been advocated to improve comfort, increase socket stability and improve suspension during weighted activities. However, no research studies have been conducted to validate these claims or compare this socket design to a more traditional design. This pilot study will use subject surveys, functional testing and advanced kinematic analysis to compare high fidelity and traditional socket designs. Our study will employ cutting edge methodology of bi-plane videoradiography (XROMM), as well as evaluate the capabilities and limitations of traditional optical motion capture methods using the XROMM as the "gold standard" for dynamic skeletal motion measurement. Although preliminary studies have been conducted to examine the interface of lower limb prosthetics. Bi-plane videoradiography has not been applied to analysis of the upper extremity prosthetic fit. This pilot study will provide preliminary data to guide decisions regarding upper limb prosthetic socket prescription for future VA studies of advanced upper limb prosthetics.