2011-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646090摘要：任務導向式肌力訓練可有效改善慢性期中風病人的行走能力。然而，此種運動訓練對於亞急性期中風病人的長期療效尚未被驗證。本研究三個主要目的為：探討4 週之任務導向式下肢肌力訓練對亞急性期中風病患大腦功能性連結、動作功能、體能活動度及生活品質評估之長期療效；這些療效評估間之相關性；及可預測這些療效之因子。本研究為單一中心、單盲設計之臨床隨機控制長期追蹤。將徵召120 位亞急性期初次中風病患，分層隨機將受試者分配至實驗組(60 位)及控制組(60 位)。實驗組將於中風後第30 天(D30)開始接受為期4 週的任務導向式下肢肌力運動訓練、每週3 次、每次1小時。控制組亦於D30 起接受相同運動劑量之非功能性活動式下肢訓練。訓練之療效分為主要及次要試驗指標。前者為臨床功能評估，含下肢動作能力、活動能力、體能活動度及生活品質。後者為受試者擴散頻譜造影之大腦皮質脊髓徑完整度及其在執行患側腳踝背屈時功能性磁振造影測得之大腦活化情形。兩種指標皆將於訓練前、訓練後、D90、D180 及D360 進行評估。此研究結果將提供應用任務導向式下肢肌力訓練於亞急性期中風病人之實證醫學證據，並進而找出訓練後患者在國際功能分類模式三功能層面進步程度之預測因子。<br> Abstract: Task-oriented exercises combined with strengthening have been shown effective inimproving walking functions in patients with chronic stroke. However, similar approaches oftherapeutic exercises have not been applied to subacute stroke with long-term follow-up,using outcome measures across the three levels of functioning (body functions/structure,activities, and participation) of the International Classification of Functioning, Disability, andHealth (ICF) model. Therefore, this study will be conducted to fulfill three purposes:1. To investigate the long-term effects of a four-week task-oriented lower extremitystrengthening training (TOLEST) program in patients with subacute stroke;2. To investigate the interrelationships among functional connectivity of the brain, lowerextremity motor functions, physical activity level, and quality of life in patients withstroke who have received this four-week TOLEST program in the subacute phase ofstroke; and3. To identify prognostic factors for recovery in functional connectivity of the brain, lowerextremity motor functions, physical activity level, and quality of life in patients withstroke who have received this four-week TOLEST program in the subacute phase ofstroke.This proposed research is a single-center, single-blind, randomized controlled trial (RCT)with long-term (one year) follow-up of outcomes. One hundred and twenty patients withfirst-onset cortical or subcortical ischemic stroke at the subacute stage (within 20 to 30 dayspost onset) will be recruited from the National Taiwan University Hospital and be randomizedinto the experimental (EXP) and control (CON) groups, with 60 subjects in each group. Therandomization will be stratified based on lesion location (cortical versus subcortical lesion)and the National Institutes of Health Stroke Scale (NIHSS, NIHSS≦6, 7-15, and ≧16). Onthe 30th day post stroke (D30), the EXP group will start to receive the TOLEST program forfour weeks, one hour per session and three sessions per week. The TOLEST focuses on usingtask-specific circuit training combined with strengthening of bilateral lower limbs. The CONgroup will receive equal-dose exercises starting on D30, with the emphasis on stretching andnon-functional movements of the affected lower extremity.The effects of the four-week intervention will be assessed with primary and secondaryend points, which cover assessments of the three levels of functioning of the ICF model. Theprimary end points consist of clinical assessments of the lower extremity motor functions,mobility, physical activity level, global functioning, and quality of life. The secondary endpoints are cortical activations associated with affected ankle dorsiflexion movements,measured by using functional MRI (fMRI), and the structural connectivity of corticospinaltracts, detected by using diffusion spectrum imaging (DSI). The primary and secondary endpoints will be performed on 5 time points: pre-training, post-training, 90th day post onset(D90), 180th day post onset (D180), and 360th day post onset (D360).Results of this study will shed light on the feasibility and its long-term impact onmultiple levels of functioning in subacute stroke. This study will also lead to identification ofprognostic factors for recovery across these three levels of functioning in subacute stroke.