Combining Robot-Assisted Therapy With Neuro-muscular Electrical Stimulation on Sensorimotor Function, Daily Function, and Quality of Life in Patients With Stroke: A Randomized Controlled Trial

目的：探究機器輔助療法合併神經肌肉電刺激、機器輔助療法合併安慰性電刺激及劑量配對的職能治療對於慢性中風患者感覺動作功能、日常生活功能及生活品質之療效。 設計：單盲隨機分派、前後測之安慰劑控制組試驗 環境：五醫學中心 介入：29名慢性中風個案，隨機分派至機器輔助療法合併神經肌肉電刺激組(robot-assisted therapy combined with neuro-muscular electrical stimulation, RTES)、機器輔助療法合併安慰性電刺激組(robot-assisted therapy combined with placebo-controlled stimulation, RTPS)或劑量配對的職能治療組(control treatment, CT)，接受每日90至100分鐘、每週五天、持續四週共20次的介入。 成效評量：主要成效評量工具包含手臂動作調查測試表(Action Research Arm Test, ARAT)、動作活動日誌(Motor Activities Log, MAL)及中風影響量表(Stroke Impact Scale, SIS)；次要成效評量工具包含修訂版諾丁漢感覺評估量表(revised Nottingham Sensory Assessment, RNSA)、上肢肌力量表(Medical Research Council scale, MRC)、修訂版艾許沃斯量表(Modified Ashworth Scale, MAS)及艾德萊德活動量表(Adelaide Activities Profile, AAP)。針對疼痛及疲勞之不良反應，採用視覺類比量表(Visual Analogue Scale, VAS)。 結果：於MAL中的動作品質(quality of movement, QOM) (F2, 26 = 5.243, P = .013, partial η2 = .295)、SIS中的日常生活活動(activities of daily living, ADL) (F2, 26 = 3.779, P = .037, partial η2 = .232)及MAS中的遠端動作(distal subscore) (F2, 26 = 3.374, P = .050, partial η2 = .213)及手腕屈肌(wrist flexors) (F2, 26 = 4.319, P = .024, partial η2 = .257)分數達統計上顯著及高度效果值，後設分析結果顯示RTES組較RTPS組及CT組有較大的改善效果。ARAT量表中的捏(pinch)次量表(F2, 26 = 2.124, P = .141, partial η2 = .145)及粗大動作(gross motor)次量表(F2, 26 = 2.226, P = .129, partial η2 = .151)、及MAS中的手指屈肌(finger flexors) (F2, 26 = 2.491, P = .103, partial η2 = .166)未達顯著但達高度效果值，同樣顯示RTES組較RTPS組及CT組具較大效果。此外，RTES組在ARAT總分達中度效果值(F2, 26 = 1.261, P = .301, partial η2 = .092)。而RTES組及RTPS組相較於CT組在ARAT抓握(grip)次量表(F2, 26 = 1.038, P = .369, partial η2 = .077)及MAL的使用量(amount of use, AOU)次量表(F2, 26 = 1.526, P = .237, partial η2= .109)達中度效果值。RTPS組相較RTES組及CT組於SIS (F2, 26 = 2.272, P=.124, partial η2 = .154)達高度效果值；於SIS的移行(mobility)次量表(F2, 26 = 1.616, P = .219, partial η2 = .114)、AAP (F2, 26 = 1.433, P = .258, partial η2 = .103)及疲勞程度(F2, 26 = 1.496, P = .243, partial η2 = .107)達中度效果值。然而，於RNSA的觸覺(tactile)次量表中，CT組較RTES組及RTPS組具較好療效，達中度效果值(F2, 22 = 1.383, P = .273, partial η2 = .116)；另於MAS的近端分數達高度效果值(F2, 26 = 3.374, P = .050, partial η2 = .213)。 結論：本研究支持合併機器輔助療法及神經肌肉電刺激於慢性中風病人的精細動作功能、日常生活功能及生活品質有正向療效；但於感覺功能方面，劑量配對的職能治療組則呈現較好療效。但本研究中各組樣本數過小，須仔細解釋結果，建議未來研究擴大樣本數進一步探討療效。Purpose. This study aimed to investigate the differential effects of robot-assisted therapy combined with neuro-muscular electrical stimulation (RTES), robot-assisted therapy combined with placebo-controlled stimulation (RTPS), and control treatment (CT) on sensorimotor function, daily function, and quality of life in patients with chronic stroke. Design. A single-blinded, randomized, placebo-controlled pilot trial, with pretest and posttest measures. Settings. Rehabilitation units in five medical centers. Interventions. Twenty-nine participants received one of RTES, RTPS, or CT for 90-100 minutes per day, five days per week, lasting for four weeks. Outcome measures. Primary outcomes were Action Research Arm Test (ARAT), Motor Activity Log (MAL), and Stroke Impact Scale (SIS). Secondary outcomes were revised Nottingham Sensory Assessment (RNSA), Medical Research Council scale (MRC), modified Ashworth scale (MAS), and Adelaide Activities Profile (AAP). Outcome measures for the adverse effects were Visual Analogue Scale (VAS) on pain and fatigue. Results. There were statistically significant differences and large effects on quality of movement subscale for the ARAT (F2, 26 = 5.243, P = .013, partial η2 = .295), activities of daily living domain for the SIS (F2, 26 = 3.779, P = .037, partial η2 = .232), the MAS distal subscore (F2, 26 = 3.374, P = .050, partial η2 = .213), and the wrist flexors (F2, 26 = 4.319, P = .024, partial η2 = .257); post hoc analysis showed the RTES group was superior to the RTPS and CT groups. Despite there was no significant difference between three groups, there were large effects on ARAT pinch (F2, 26 = 2.124, P = .141, partial η2 = .145) and gross motor subscale (F2, 26 = 2.226, P = .129, partial η2 = .151), and finger flexors score of the MAS (F2, 26 = 2.491, P = .103, partial η2 = .166); it revealed that the RTES group was superior to the RTPS and CT groups. Additionally, there was moderate effects on ARAT score (F2, 26 = 1.261, P = .301, partial η2 = .092) and represented that the RTES group was superior to the RTPS and CT groups. On the other hand, there were moderate effects on ARAT grip subscale (F2, 26 = 1.038, P = .369, partial η2 = .077) and amount of use subscale for the MAL (F2, 26 = 1.526, P = .237, partial η2= .109), and it suggested that the RTES and RTPS groups were superior to the CT group. There was large effect on the SIS (F2, 26 = 2.272, P=.124, partial η2 = .154) but revealed the RTPS group improved quality of life mostly. Also, there were moderate effects on mobility subscale for the SIS (F2, 26 = 1.616, P = .219, partial η2 = .114), the AAP (F2, 26 = 1.433, P = .258, partial η2 = .103), and the degree of fatigue (F2, 26 = 1.496, P = .243, partial η2 = .107); revealed that the RTPS group had the best improvement. Surprisingly, the CT group had the best effect on tactile subscale for the RNSA (F2, 22 = 1.383, P = .273, partial η2 = .116) and proximal subscore of the MAS (F2, 26 = 3.374, P = .050, partial η2 = .213). Conclusion. This study supports the positive effects of RT combined with NMES on fine motor function, daily function, and quality of life. For the sensory function, the CT group has the best effect than RTES and RTPS groups. Due to the small sample size in each group, the results should be interpreted carefully and need further studies to investigate.口試委員會審定書 I Acknowledgement II 中文摘要 IV ABSTRACT VI Table of Contents VIII List of Figures X List of Tables XI CHAPTER 1. INTRODUCTION 1 1.1 Background 1 1.2 Study Purposes and Hypotheses 5 CHAPTER 2. METHODS 6 2.1 Study Design and Procedures 6 2.2 Participants 7 2.3 Apparatus and Settings 8 2.3.1 Bi-Manu-Track (BMT) 8 2.3.2 Neuro-muscular electrical stimulation (NMES) 8 2.3.3 Settings 9 2.4 Interventions 10 2.4.1 Robot-assisted Therapy with Neuro-muscular Electrical Stimulation (RTES) group 10 2.4.2 Robot-assisted Therapy with Placebo-controlled Stimulation (RTPS) group 11 2.4.3 Control Treatment (CT) group 12 2.5 Outcome Measures 13 2.5.1 Primary Outcomes 14 2.5.2 Secondary Outcomes 15 2.5.3 Outcomes for Adverse Effects 17 2.6 Data Analysis 18 CHAPTER 3. RESULTS 19 3.1 Study Participation and Baseline Characteristics of the Participants 19 3.2 Effects of Interventions on Primary Outcomes 20 3.3 Effects of Interventions on Secondary Outcomes 22 3.4 Adverse Effects 24 CHAPTER 4. DISCUSSION 25 4.1 Summary of the Study Results 25 4.2 Superior Effects of the RTES to RTPS or CT 27 4.3 Effects of RTES and RTPS relative to CT 30 4.4 Tantamount Effects of RTES, RTPS, and CT 32 4.5 Implication of This Study 34 4.6 Study Limitations and Recommendation for Further Studies 35 CHAPTER 5. CONCLUSIONS 36 REFERENCES 3