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研究生： 陳聖元
Sheng-yuan Chen
論文名稱： 退化性膝關節炎之楔型與客製化鞋墊的設計及評估
Design and Evaluation of Wedged and Personalized Insole for Knee Osteoarthritis
指導教授： 林上智
Shang-chih Lin
口試委員: 蔡文基
Wen-ji Tsai
許維君
Wei-chun Hsu
陳福基
Fu-ji Chen
學位類別： 碩士
Master
系所名稱： 應用科技學院 - 醫學工程研究所
Graduate Institute of Biomedical Engineering
論文出版年： 2012
畢業學年度： 100
語文別： 中文
論文頁數： 106
中文關鍵詞： 退性膝關節炎 、楔型鞋墊 、客製化鞋墊 、輔具
外文關鍵詞： Knee osteoarthritis, Wedged insole, Personalized insole, Orthotic device
相關次數： 點閱：396  下載：22 
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    • 隨著生活型態的改變及醫學工程進步，人類平均壽命逐年延長，根據內政部統計至2012年5月老年人口比例約為10.9%，台灣進入高齡化社會後疾病的醫療資源需求將會越來越高，其中退化性膝關節炎患者數目就是明顯的例子；臨床上治療方式有使用輔具、服用非類固醇類之消炎藥、注射藥物等，或是侵入式的外科手術修補或置換人工膝關節，若想非侵入式影響膝關節受力與排列情況下，鞋墊形式的輔具會是一種方法，更是避免藥物副作用、手術風險且患者最能接受的輔具。
    國外對鞋墊矯正已有相當的研究，但國內對楔形鞋墊使用於退化性膝關節炎患者不普及、生物力學研究欠缺，因此本研究目的是使用文獻研究中楔型鞋墊改良模組化角度，並取25位病患進行立即性改善數據分析；另一方面加入五大客製化元素有幾何、力學、材料、醫學、美學改良楔型鞋墊來符合醫療輔具實務上使用價值，並取20位病患針對長期穿著一個月進行滿意度測試及改善數據分析，其包含有WOMAC與Lequesne’s疼痛問卷評估、足型足壓、放射線檢查及行為活動疼痛困難測試，最後統計分析以了解楔型角度鞋墊其改善病患之疼痛有效性及客製元素是否能在維持原生物力學影響下，提升退化性膝關節炎病患使用客製化楔型鞋墊之滿意度。
    結果數據分析顯示：性別、體重和身高比例會增加罹患內側退化性膝關節炎發生率，在穿著模組化楔型鞋墊和客製化退化性膝關節炎鞋墊，都能讓內側膝關節炎病患穿著後，在主觀疼痛感受與活動行為上顯著改善，以及調整嚴重側足壓比例效果，嚴重退化者更在穿著楔型鞋墊後有股骨-脛骨角度改善差異；客製化楔型鞋墊能藉由五大元素達到楔型鞋墊舒適、穩定及美學上八成五以上滿意度。

    Due to lifestyle changes and medicine advances, the average age of the human being is gradually increased. The latest report form the Ministry of the Interior in Taiwan shows that the proportion of elder population in May 2012 is about 10.9%. After the Taiwan enters the high-aged society, both medical requirement and cost are significantly raised. One of the most obvious examples is knee osteoarthritis. Clinical treatments for knee osteoarthritis include orthotic devices, nonsteroidal anti-inflammatory drug, medicine injection, and invasive surgery such as total knee arthroplasty. Among them, the use of insoles is an alternative to treat the knee osteoarthritis that the worn cartilage is limited at the medial condyle. From the biomechanical viewpoint, the insoles can avoid side effect of drug and potential risk of surgery.
    In literature, there have a great many of studies devoted to investigate the influence of the insoles on the knee osteoarthritis. However, the insoles used in those studies were often designed with the wedged shape at the insole bottom. The effect of the three-dimensional profile at the insole surface on the patient’ comfort and pain relief were not considered. Consequently, the effects of wedged and personalized insoles on the knee osteoarthritis constructed the major motion of this study.
    The clinical trials of the wedged and personalized insoles were divided into two stages: immediately and one-month after wearing insoles. At the first stage, twenty-five patients were chosen to participate in the clinical trial of modular wedged insoles. After one month, twenty patients continued to take part in the second stage of the subsequent trial that the insoles were especially personalized according the pressure distribution and three-dimensional profile of the patient’ foot. The evaluation indices included the changes in the knee joint X-ray, the pain score of WOMAC and Lequesne's questionnaire assessment, the foot pressure of daily activities.
    The results of the current study revealed that sex and weight-height ratio (BMI) will increase the risk of medial knee osteoarthritis. There were significant changes in the WOMAC , Lequesne's pain score and behavioral activities after using the modular and personalized wedged insole. The satisfaction questionnaire results demonstrated that personalized laterally wedged insoles are significantly beneficial in the management of medial knee osteoarthritis.

    中文摘要I 英文摘要II 誌謝III 目錄IV 圖目錄VII 表目錄X 本文 第一章 緒論 1 1-1 研究背景 1 1-2 正常膝關節介紹 3 1-2-1 膝關節解剖構造介紹 3 1-2-2 膝關節運動穩定結構 7 1-3 退化性膝關節炎（Osteoarthritis knee） 10 1-3-1 退化性膝關節炎成因 10 1-3-2 退化性膝關節炎症狀 13 1-3-3 退化性膝關節炎分級 17 1-3-4 退化性膝關節炎治療 19 1-3-5 退化性膝關節炎評估 21 1-3-6 膝關節步態分析量測 22 1-4 退化性膝關節炎輔具治療原理 25 第二章 研究文獻回顧 27 2-1 退化性膝關節炎之生物力學研究 27 2-2 退化性膝關節炎之疼痛感受研究 30 2-3 退化性膝關節炎之放射線類研究 32 2-4 退化性膝關節炎之鞋墊設計研究 33 2-5 研究動機與目的 37 第三章 研究材料與方法 39 3-1 研究對象 39 3-2 研究設備 40 3-2-1 退化性膝關節炎鞋墊製作 40 3-2-2 臨床參數量測實驗之設備 43 3-3 退化性膝關節炎客製鞋墊研究 45 3-3-1 退化性膝關節炎鞋墊設計原理 45 3-3-2 退化性膝關節炎客製鞋墊改良 46 3-4實驗流程與評估項目 49 3-4-1 實驗兩階段時程規畫 49 3-4-2 基本資料與問卷評估 54 3-4-3 足形足壓與病理判斷 55 3-4-4 下肢膝關節外型拍照 57 3-4-5 角度與曲度模組選配 57 3-4-6 雙足膝關節Ｘ光拍攝 59 3-4-7 動靜態行動疼痛評估 61 3-5 實驗統計方法 61 第四章 結果 64 4-1 受測者基本資料 64 4-2 新型楔型鞋墊設計結果 65 4-2-1 客製化楔型鞋墊改良 65 4-2-2 鞋墊試穿滿意度評估 69 4-2-3 下肢外型改變量測結果 71 4-3 鞋墊臨床實驗量測結果 72 4-3-1 疼痛指數問卷評估 72 4-3-2 膝關節骨變形量測 76 4-3-3 足底壓力變化分析 79 4-3-4 壓力中心晃動紀錄 82 4-3-5 臨床活動行為測試 84 第五章 討論 89 5-1 受測者基本資料 89 5-2 客製化鞋墊設計 90 5-2-1幾何設計(雙流線型、半足楔型) 90 5-2-2力學設計(足壓均佈、吸震緩衝) 90 5-2-3材料設計(高硬度材、高彈性材) 91 5-2-4美學設計(表面貼皮、鞋款搭配) 92 5-3 疼痛問卷之評估 93 5-4 關節放射線檢查 93 5-5 足底壓力之數據 94 5-6 活動行為之評估 95 第六章 結論 97 參考文獻 100

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