機器輔助療法於中風患者上肢動作功能、日常生活功能、疼痛與疲勞之影響

Abstract

背景與目的: 機械輔助療法乃是一種藉由高科技治療儀器，融合高治療強度的動作練習與多元的感覺動作刺激等治療原理，來達到促進中風患者上肢動作功能復原的治療方法。多有研究指出機械輔助療法有助於提升慢性中風患者的上肢動作功能，卻少有研究顯示此療效能有效改善患者的日常生活功能表現。本研究旨在探討高強度機械輔助治療(Intensive Robot-assisted Therapy, IRT)，是否比治療劑量配對的控制療法 (Control Intervention, CI) 更能促成上肢動作復健療效與功能性活動表現。我們並藉由了解患者主觀的疼痛、疲勞反應，以期探討慢性中風個案對此治療方式的耐受性。 研究方法：本研究設計為多中心單盲隨機分派試驗。自民國99 年7 月1 日至民國100 年6 月19 日止，共收納20 位慢性中風半側偏癱患者。受試者分別被隨機分派至高強度機械輔助治療組(IRT group)與治療劑量(時間)配對控制治療組(CIgroup)，並接受每次105-120 分鐘、每週4-6 次、為期3-4 週，共18-20 天的治療。應世界衛生組織(WHO)於2001 修訂之「國際健康功能與身心障礙分類系統(International Classification of Functioning, Disability and Health)」，我們使用傅格-梅爾動作復原評估量表(Fugl-Meyer Assessment)評估患者上肢動作功能(Body function)、雙手操作能力問卷(ABILHAND)與生活功能獨立程度量表(Functional Independent Measure)評估患者活動與參與的表現(Activity and Participation)，並以視覺化類比量尺(Visual Analogue Scale)探知患者主觀疼痛與疲勞反應，評量環境影響因素。 研究方法： 受試者皆全數完成試驗，兩組個案在臨床特徵與上肢動作功能表現 皆無顯著差異。患者在接受合併式高密度機械輔助治療 (cHRT) ，以及劑量配對控制治療組 (CI) 後，兩組別的自評疼痛程度 (F(1,19)= 8.062, P= .011, η2= .322)與疲勞程度 (F(1,19)=.090, P= .767, η2= .005) 並未呈現顯著差異。高強度機械輔助治療組(IRT group) 的動作功能改善較控制治療組 (CI) 佳，組間差異達統計顯著 (Fugl-Meyer Assessment , F(1,19)= 7.66, P= .013, η2= .31)。前者療效亦呈現較好的趨勢，該組在上肢動作近遠端的進步幅度皆優於控制治療組 (CI)。在活動與參與層面 (Activity and Participation) ， 兩組不論在雙手操作能力問卷(ABILHAND, F(1,19)= .374, P= .549, η2= .022) 或生活功能獨立程度量表(Functional Independent Measure, F(1,19)= 3.025, P= .097, η2= .131) 都未達統計顯著。然而，高強度機械輔助治療組(IRT group)雙手操作能力改善程度具有較好的進步趨勢，控制治療組 (CI) 則在日常生活功能層面顯示較好的進步趨勢。 結論: 高強度機械輔助治療 (IRT)應可適用於改善輕度至中度偏癱慢性中風患者的上肢近、遠端動作功能。然而，此療法在促進功能性活動的面向，並未優於劑量配對的傳統治療。

Background: Stroke survivors are limited in their daily functions due to restrictedmotor function. None Robot-assisted Therapies (RTs), providing intensive sensorimotor approaches, has been established as effective on both upper extremity(UE) motor function and performance of daily livings for patients with chronic stroke. Objective: To determine whether the Intensive Robot-assisted Therapy (IRT) is safe, tolerable and effective on both UE motor recovery and functional performance of chronic stroke survivors. Methods: Multi-centered randomized controlled trial involved 20 chronic stroke participants with mild to moderate hemiparesis between July 1, 2010, and June 19,2011. Patients were randomly assigned to IRT and dose-matched (i.e.,matched on therapy hours) control intervention (CI) to receive 18-20 sessions (105-120 mins/day,4-6 days/wk, 3-4 weeks). Based on the ICF model, we choose Fugl-Meyer Assessment (FMA) as primary outcome measure to assess the body function domain; ABILHAND and Functional Independent Measure (FIM) as the secondary outcomes to measure the activities and participation domain; Visual Analogue Scale as the contextual domain to assess adverse effects. Results: 20 participants completed our intervention protocols, no significant between-group differences were found in baseline characteristics. Significant between-group difference and large effect were shown on the FMA total score(F(1,19)= 7.66, P= .013, η2= .31) after treatment. The IRT group, as compared to CI, showed greater improvements in both proximal shoulder-elbow level and distal forearm-wrist-hand level on FMA scale; however, non-significant differences were reported on both ABILHAND scale (F(1,19)= .374, P= .549, η2= .022) and FIM(F(1,19)= 3.025, P= .097, η2= .131) after treatment. IRT did not show excessive adverse effects in comparison to CI. Conclusions: It may be feasible to deliver the IRT for chronic stroke patients with mild to moderate hemiparesis. The current results suggest that IRT is beneficial to improve UE motor function at both proximal and distal level without causing excessive adverse effects; however, this new intervention regimen may not adequate to drive significant differences on functional performance in comparison to CI.