單、雙肢複合療法改善慢性中風個案上肢功能的對比試驗

Abstract

背景及研究目的 大部分的中風患者留有長期上肢動作功能損傷，急性期過後的動作復原主要仰賴神經復健介入，機械輔助療法、侷限誘發療法及雙側上肢訓練等都被視為具有潛力的神經復健手法。不同的介入手法各有其特色、療效及限制，合併不同手法成為複合療法，也許能提供優於或異於單一療法的治療成效，並為神經復健帶來更多元化及個別化的介入選擇。此研究具以下三項研究目的：第一，檢驗複合療法相較於機械輔助療法的療效差異；第二，比較單、雙側複合療法於動作功能、日常活動、生活品質等不同面向之療效；第三，檢驗治療後三個月的持續療效及可能的延遲效應。 方法 此研究為隨機分派試驗，共募集45位慢性中風患者，並隨機分派至單側複合治療組、雙側複合治療組或機器輔助治療組中之一組，接受為期6週的療程、治療前、後評量及療程結束後3個月的追蹤測驗。主要成效評量工具包含傅格梅爾動作量表(Fugl-Meyer Assessment, FMA)及中風影響量表(Stroke Impact Scale Version 3.0, SIS)，次級成效評量工具包含醫學研究會議之肌力量表、Jamar握力測定器、 Jamar指捏力測定器、沃夫動作功能測驗(Wolf Motor Function Test, WMFT)、低功能動作活動紀錄表(Lower Functioning Motor Activity Log, LF-MAL)、諾丁漢延伸性日常生活量表(Nottingham Extended Activities of Daily Living scale, NEADL)、柯氏上臂與手部活動評量表(Chedoke Arm and Hand Activity Inventory, CAHAI)測量患者執行功能性活動的能力，及目標達成量表(Goal attainment scaling, GAS)。治療前後使用視覺類比量表評估疼痛及疲勞作為不良反應監測。復原率及達最小臨床重要差異(minimal clinically important difference, MCID)之比例用以檢視3組的復原模式。次群組比較中，則依治療前動作功能將受試者分為中度及重度動作損傷以檢視動作功能是否影響療效。 結果 在主要成效評量中，FMA總分及遠端分數具有顯著的組別與時間交互作用(F3.2, 66.4 = 3.39, p = 0.02; F4, 82 = 2.93, p = 0.03)，事後檢定發現，雙側複合治療組在治療後評量的FMA總分及遠端分數表現顯著優於單側複合治療組(p = 0.03及0.04)；雙側複合治療組在治療後三個月追蹤的FMA總分顯著優於單側複合治療組(p = 0.01)，治療後三個月追蹤的FMA遠端分數顯著優於單側複合治療組及機器輔助治療組(p = 0.047 及 0.03)。SIS中，3組間沒有顯著的組別與時間交互作用及組別間效應，但各項目均有顯著的時間效應，顯示3組在治療後均有顯著進步。次級評量結果顯示，在肌力、握力、捏力、WMFT、LF-MAL及CAHAI中，3組在治療後均顯著進步，但沒有組間差異；在NEADL移行項目中，3組具顯著組間差異(F 2, 40 = 4.14, p = 0.02, partial η2 =0.175)，事後檢定顯示機器輔助治療組顯著優於雙側複合治療組(p < 0.01)；在GAS中，3組具有顯著組間差異(F 2, 40 = 16.19, p < .01, partial η2 =0.454)，事後分析顯示雙側複合治療組優於單側複合治療組及機器輔助治療組(p = 0.05及p < 0.01)，而單側複合治療組又優於機器輔助治療組(p < 0.01)。次群組比較中顯示，治療前的動作功能會影響FMA總分、FMA近端分數、SIS手功能項目、及WMFT的進步幅度。 結論 研究結果顯示，中度到重度動作損傷的慢性中風患者經過六週的治療後，雙側複合療法在動作功能，尤其是遠端動作功能，療效優於單側複合療法；雙側及單側複合療法在功能性目標的效益優於機器輔助療法；而機器輔助療法在功能性移行上較有幫助。雙側複合療法在遠端動作功能的長期療效優於單側複合療法及機器輔助療法。三種療法在生活品質的進步均能維持至治療結束後三個月。動作功能的程度不同，可能會影響治療後，在上肢動作功能及日常活動的進步量。治療後患者的疲勞或疼痛感均無明顯增加，顯示複合療法為臨床可行且安全的介入手法。此研究幫助我們充實由機器輔助療法及任務導向組成的複合療法運用於慢性中風復健的成效，揭示功能性目標導向、個別化治療與高科技復健輔具結合的可能性，有助於未來複合療法的研究發展及科技輔具的實證應用。

Background and Purposes Most of stroke survivors are left with long-term deficits, especially the motor impairment in upper extremity that influences the participation in daily life. After the acute stage, the recovery of the motor function mainly depends on neurorehabilitation. Robot-assisted therapy (RT), constraint-induced therapy (CIT), and bilateral arm training (BAT) are three of promising strategies in neurorehabilitation. The characteristics, effects, and constraints are various among different strategies. Hybrid therapy that combines different strategies may provide treatment effects that better than or different from single intervention, and may further expand the diversity and individualized intervention strategy of stroke rehabilitation. The purposes of this study were threefold: first, to examine the effects of hybrid therapy relative to RT on clinical outcomes; second, to compare the treatment effects between unilateral hybrid and bilateral hybrid rehabilitation; and third, to examine the retention effects and possible delayed response of the interventions at 3-month follow-up. Methods This study was a randomized controlled trial. Forty-five participants with chronic stroke were randomized into the UHT, BHT, or the RT group for a 6-week intervention, before, immediately after and 3-month follow-up. Primary outcomes were Fugl-Meyer Assessment and Stroke Impact Scale Version 3.0 (SIS). Secondary outcomes included the Medical Research Council scale (MRC), Jamar dynamometer and pinch gauge, Wolf Motor Function Test (WMFT), Lower Functioning Motor Activity Log (LF-MAL), Nottingham Extended Activities of Daily Living (NEADL) scale, Chedoke Arm and Hand Activity Inventory (CAHAI), and the goal attainment scaling (GAS). The 2-way mixed-measures analysis of covariance (ANCOVA) and ANCOVA was used to investigate the effects among the 3 treatments. The recovery rate and the proportion of minimal clinically important difference (MCID) were used to examine the recovery pattern of the 3 groups. To investigate the impact of pretreatment motor ability on the treatment effects, in the subgroup analysis, we compared the treatment effects between participants with moderate motor impairment and severe motor impairment. Results On the primary outcomes, the significant group × time interactions were found on the FMA total score and FMA distal score (F3.2, 66.4 = 3.39, p = 0.02; F4, 82 = 2.93, p = 0.03). The BHT group performed significantly better than the UHT group on the posttest FMA total score, posttest FMA distal score and follow-up FMA distal score (p = 0.03, 0.04, and 0.047), and significantly better than the RT group on the follow-up FMA distal score (p = 0.03). No significant group × time interaction was found on any domain of SIS, but significant time effects were found on all domain of SIS, indicating 3 groups had significant improvement after the interventions. On the secondary outcomes, 3 groups improved significantly on MRC, grip power, pinch power, WMFT, LF-MAL, and CAHAI without between-group difference. On the mobility domain of NEADL, significant between-group difference was found (F 2, 40 = 4.14, p = 0.02, partial η2 =0.175), favoring the RT group than the BHT group (p < 0.01). On the GAS, there was significant between-group difference (F 2, 40 = 16.19, p < .01, partial η2 =0.454) favoring the BHT than the UHT and RT (p = 0.05 and p < 0.01), and favoring the UHT than the RT (p < 0.01). The subgroup analysis showed that the upper limb motor ability would have impact on FMA total score, FMA distal score, hand function domain of SIS, pinch power, WMFT, LF-MAL, and CAHAI. Conclusions The results of this study suggest that the BHT had better treatment effect on upper limb motor ability, especially on the distal part, than the UHT on patients of chronic stroke with severe to moderate motor impairment. The UHT and BHT showed better outcome on functional goal attainment than the RT. The RT showed benefit on independent ambulation. The BHT group showed better retention effect on distal motor ability than the UHT and RT group. The improvements on quality of life retained at least 3 months after the 3 interventions. The upper limb motor ability on the baseline would affect the treatment effect on upper limb motor ability in the BHT group. There was no significant increase on pain or fatigue after 3 treatments, indicating the feasibility and safety of hybrid therapy. Based on the results, the hybrid therapies were suggested to promote the attainment of individualized functional goal, and the BHT and RT were suggested to enhance the upper limb motor ability and independent ambulation respectively on stroke patients with severe to moderate motor impairment. The study enriched our understanding of the hybrid therapies that combined the RT and task-specific training in the stroke rehabilitation. The experiences showed the possibility of combining the high-tech assistive products with functional-oriented and individualized interventions. The promising results provide knowledge for future research on hybrid therapy and the evidence-based application of high-tech assistive products.