2015-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646656摘要：中風在是健康照護負擔沈重的國人重大疾病之一，當代復健療法包含侷限誘發療法、雙側肢體訓練，和機械輔助療法等。侷限誘發療法與雙側肢體練習療法，分別基於單側和雙側肢體的密集功能練習概念。機械輔助療法雖已成為一項深具潛力的復健輔助科技，若能充分結合機械輔助治療和治療師導引的密集療法，可望增強既有療效。然而，「混合療法」雖具創新性與應用潛力，目前尚不具備充分的實證研究，亟需驗證，以利廣泛應用於臨床。此外，患肢與雙肢混合療法可能各有裨益，亟需研究釐清。有鑒於此，本研究案將檢驗： (1)單側複合式、雙側複合式、與對照療法（單側與雙側機械輔助療法）在動作功能、日常功能、移行、生活品質，以及動作控制策略上的療效；(2) 單側與雙側複合療法在不同面向的療效差異；(3) 三個月後的持續療效與可能的延遲效應；(4) 療效的預測因子，用以定義可自不同複合式療法中獲益的適用族群；(5) 所使用之活動功能與移位功能等評量的計量特性，以提供往後研究、臨床上使用複合式復健療法前後，評量工具的選擇參考。此五年期計畫將施行一個隨機控制試驗，預計於三家醫院招募108 位患者。病患將隨機分派至為期六週的三組療法中的一組：單側複合式、雙側複合式，或機械輔助療法。主要臨床評估為傅格梅爾動作量表（Fugl-Meyer Assessment）和沃夫動作功能測驗（Wolf Motor Function Test）等動作功能評估，將於治療前、治療中（治療3 週後）、治療後，還有治療後3 個月各施測一次。次要評估包含肌肉功能測量儀（MyotonPro）、十公尺步行測試（10-meter Walk Test）、加速規（Actigraphy）、功能性獨力量表（Functional Independence Measure）、動作活動記錄表（Motor Activity Log）、雙側上肢活動量問卷（ABILHAND Questionnaire）、諾丁漢延伸性日常生活量表（Nottingham Extended Activities of Daily Living Scale）、中風影響量表（Stroke Impact Scale Version 3.0），將於治療前、治療後，還有治療後3 個月各施測一次。資料分析將使用雙因素重覆測量（two-way repeated）共變數分析（ANCOVA）以檢驗不同治療組別在成效指標評量之效應，並以前測分數做為共變數。效應值η2 將用以計算三種治療組在不同成效指標上的療效大小。此外，此研究將使用對數迴歸分析找出各成效指標之顯著預測因子。各種臨床成效評量工具之反應性和效度將分別使用標準化反應平均值（standardized response mean）和Spearman 相關係數檢定之。完成此計畫後，我們預期將可廓清單側複合療法與雙側複合療法之相對成效、影響個別治療法療效之因子、與過去尚未檢驗的成效評量工具之計量特性等實證結果。研究結果將促使我們更了解複合療法提升中風患者功能之成效與機制。整體而言，此研究計畫將有助於促進我國實證復健之發展，驗證機械輔助任務導向密集治療之成效，充實中風復健成效之本土資料，並將治療性科技輔具與動作科學研究的知識與技術轉譯至中風等國人重大疾病之神經復健。<br> Abstract: Stroke remains a major health care burden and challenge for effective intervention. Contemporary approaches to stroke rehabilitation that have gained clinical popularity include constraint-induced therapy (CIT), bilateral arm training (BAT), and recently emerging robot-assisted therapy (RT). CIT and BAT are based on the concepts of unilateral and bilateral approaches to intensive practice on functional tasks, respectively. Although robot-assisted therapy (RT) has emerged as a promising assistive technology, stroke rehabilitation outcomes may be augmented by means of combining RT and task-oriented therapy. In addition, the unilateral and bilateral approaches to stroke rehabilitation may confer differential benefits that await scrutiny; therefore, this project will (1) compare the effects of unilateral hybrid therapy (unilateral RT + CIT), bilateral hybrid therapy (bilateral RT + BAT), and the control intervention (unilateral and bilateral RT) on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients; (2) examine the comparative treatment effects between unilateral hybrid and bilateral hybrid rehabilitation on various aspects of outcomes; (3) examine the retention effects and possible delayed response of the interventions at 3-month follow-up; (4) examine the predictors of treatment success to define the appropriate candidates for each therapy; and (5) examine the clinimetric properties, including responsiveness and clinically important difference of outcome measures of mobility and functional use of the upper limb that have yet to be established to inform research and practice.We will conduct a comparative efficacy trial with 108 stroke patients from three participating hospitals in this 5-year project. Patients will be randomly assigned to unilateral hybrid, bilateral hybrid, or RT treatment groups for 6 weeks. Primary clinical measures for motor function (i.e., Fugl-Meyer Assessment and Wolf Motor Function Test) will be administered at pretest, 3-week interim, posttest, and 3-month follow-up. Secondary clinical measures for motor capacity, motor function, and daily function (i.e., MyotonPro, 10-meter Walk Test, Actigraphy, Functional Independence Measure, Motor Activity Log, ABILHAND Questionnaire, Nottingham Extended Activities of Daily Living Scale, and Stroke Impact Scale Version 3.0) will be administered at pretest, posttest, and at the 3-month follow-up. Two-way repeated measures analysis of covariance will be applied to evaluate the between-group effects at two assessments, followed by a post hoc analysis using the Bonferroni test. The effect size of partial eta-squared (η2) will be calculated for each outcome variable to index the magnitude of the performance difference between groups. To identify the predictors, logistic regression analyses will be used. Multicollinearity will be examined for appropriate exercise of the regression analysis. The standardized response mean, defined as the mean change in score divided by the standard deviation of the changes in score, will be used to examine responsiveness of clinical outcomes.This research will provide scientific evidence of the treatment effects of unilateral vs. bilateral hybrid therapies in stroke care. The findings will help elucidate the factors relevant for success in hybrid therapies and possible mechanisms of change. The overall results will contribute to formulation of rationally based hybrid interventions and fill the gap in synergistic approaches in which robotic treatments (unilateral and bilateral) can be supplemented by therapist-mediated therapy to maximize the outcome of motor control recovery and functional gains following stroke.中風複合療法侷限誘發療法雙側肢體訓練機器輔助療法神經復健strokecombined therapyconstraint-induced therapybilateral arm trainingrobot-assisted therapyneurorehabilitation