Kinematic and Kinetic effect of Orthotic Devices for subjects with stage II Poste

描述（由申请人提供）：矫形器是胫骨后腱功能障碍（PTTD）保守治疗方案的基本要素。目前使用设备的数据仍然有限。目前的设备设计是限制性的，并且侧重于纠正II期PTTD受试者的平足运动学。限制踝关节运动的限制性设计可能导致虚弱和步态动力学改变。对于II期PTTD患者，限制性较小的装置设计是否更理想尚不清楚。当前提案的目的是检查不同装置设计的体内生物力学，并使用结果来确定装置和设计II期PTTD患者的最佳方案。研究设计：本研究将采用基于实验室的重复测量设计，在60名基线为II期PTTD的受试者样本中探索四种不同矫形器的功能。然后，每位受试者将在佩戴矫形器的情况下进行为期12周的前瞻性随访。临床结果包括力量、肌腱形态和自我报告的结果将在12周时测量。基线足部运动学将使用三段足部模型（第一跖骨、跟骨、胫骨）收集，而踝关节动力学数据将从运动学数据和地面反作用力中得出。影响：目前在II期PTTD保守治疗中使用的各种器械之间没有正面比较。拟议的研究将提供必要的受控数据，以确定所选设备的运动学和动力学效应以及优化设备设计所需的特定组件。结果将用于确定哪种设计在临床上是成功的。

DESCRIPTION (provided by applicant): Orthotic devices serve as essential elements of conservative care programs for posterior tibial tendon dysfunction (PTTD). Data on currently used devices remain limited. Current device designs are restrictive and focus on correction of flatfoot kinematics in subjects with stage II PTTD. Restrictive designs that limit ankle motion may lead to weakness and altered gait dynamics. It remains unclear if less restrictive device designs would be more optimal for subjects with stage II PTTD. The aims of the current proposal are to examine the in- vivo biomechanics of different device designs and to use outcomes to identify the device and design optimal for subjects with stage II PTTD. Research Design: This study will use a laboratory based repeated measures design to explore the function of four different orthotic devices in a sample of 60 subjects with stage II PTTD at baseline. Then each subject will be followed prospectively for 12 weeks while wearing one of the orthotic devices. Clinical outcomes including strength, tendon morphology, and self-reported outcomes will be measured at 12 weeks. Baseline foot kinematics will be collected using a three segment foot model (first metatarsal, calcaneus, tibia) while data on ankle kinetics will be derived from the kinematic data and the ground reaction forces. Impact: There are currently no head-to-head comparisons available among the various devices used in the conservative management of stage II PTTD. The proposed study will provide the necessary controlled data to determine the kinematic and kinetic effects of selected devices and the specific components needed to optimize device design. Outcomes will be used to determine which designs are successful to use clinically. PUBLIC HEALTH RELEVANCE: The lack of high quality evidence to guide conservative care for patients with posterior tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic devices are available to avoid a costly and debilitating surgery but no consensus on which to use has been made. The current study aims to link biomechanical testing of selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.