本研究之目的在於分析膝下截肢者在行走時，殘肢之受壓區/非受壓區與殘肢/義肢承筒之介面壓力的關係，從模擬與實驗量測上分別求得殘肢之受壓區/非受壓區在三種不同行走速度與穿戴兩種承筒(截肢者的原始承筒與田口方法設計的新承筒)情形下在站立期間的介面壓力變化，藉由瞭解受壓區/非受壓區之介面壓力變化之情形，作為編修殘肢曲面形狀變更之參考。以膝下截肢患者而言，義肢承筒是義肢系統中與人體殘肢直接接觸的元件，不僅僅是作為義肢在人體下肢負荷時的穩定支撐，同時，殘肢所承受的介面應力大小及分佈狀況更與承筒設計合適與否有極大關聯。然而，義肢承筒的設計製作一般來說是以純手工方式，憑義肢師的經驗與技巧，以及患者多次的試穿，最後經由多次的修改與校正方能完成。若承筒之設計不良會導致殘肢受力不均，產生穿戴的併發症，不但造成生活上的不便，更嚴重則需要再截肢。因此，在本研究中嘗試建立一套設計分析流程分析殘肢受壓區/非受壓區之介面壓力。從座標轉換原理、逆向動力學、田口方法與有限元素等分析方法與兩套量測設備之同步實驗探討殘肢之受壓區/非受壓區在站立期間的介面壓力變化。首先，利用電腦斷層掃描資料重建膝下截肢之三維模型，並且進而建立有限元素分析模型。其次，應用座標轉換原理推導出人體下肢無因次化運動模型，藉以分析人體下肢關節之運動特性。另外，利用逆向動力學推導出人體下肢動力模型，作為有限元素分析之基礎。接著，應用田口設計方法與曲面原理，搭配有限元素分析，並且建立一介面工具輔助殘肢曲面形狀之修改，設計一新承筒提供截肢者穿戴。利用兩套實驗儀器實測殘肢之12個受壓區與非受壓區在站立期時之介面應力，以作為有限元素分析結果比較的基礎，藉此瞭解殘肢所承受之介面壓力變化，期望將殘肢曲面形狀作量化編修，決定適宜之殘肢形狀來製作義肢承筒，改善手工製作義肢承筒的品質。

In the design stage of a prosthetic socket, the magnitude and distribution of the interface pressures between stump and socket are often used to evaluate whether the socket is well designed. Traditionally, socket design and manufacturing is entirely based on a prosthetist’s expertise and skill. In this study, the variation in interface pressures at pressure-tolerant (PT) and pressure-relief (PR) areas of below-knee (BK) residual limb during the stance phase at three walking speeds was investigated by employing finite element (FE) analysis and experimental measurement. Firstly, a three-dimensional FE model based on computed tomography (CT) images was established. Next, a dimensionless kinematic analysis was derived by using the coordinate transformation principle to analyze the kinematic characteristics of human lower limb. Moreover, a kinetic model of human lower limb was derived using the inverse dynamics to obtain the forces and moments applied at stump that was the foundation for boundary and loading conditions in FE analysis. Furthermore, the Taguchi method for experimental design and an interface tool were utilized to assist the shape modification of a stump at the PT and PR areas. Based on the modified stump model, a new socket was fabricated for a specific amputee to implement the experiments. Then, the interface pressures at 12 PT/PR areas of residual limb during the stance phase at three walking speeds were measured using two experimental tools (i.e. an interface pressure measurement system and a motion analysis system). From the experimental data, the interface pressure variations at the PT/PR areas of BK residual limb during walking were organized and used to validate the FE analysis results.
In this study, a computer-aided process for prosthetic socket design and analysis was established to determine stump shape by using the scanned data of the stump. The validated modified stump model was then used to fabricate a socket for the specific amputee. This proposed process for producing prosthetic socket is expected to improve the quality uncertainty and labor intensity and to prevent patient discomfort, which are pitfalls of the traditional manual method.

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