目的:评估在脑卒中患者上肢运动功能恢复和神经肌肉改善方面,采用新型三维末端执行器机器人进行双侧或单侧上肢机器人辅助康复训练是否优于常规治疗。
方法:随机化,控制,平行,评估者盲化,三臂临床试验。
方法:东南大学南京中大医院,江苏,中国。
方法:将70例脑卒中偏瘫患者随机分配到常规训练中(对照组,n=23)或单边(URT,n=23),或双边机器人训练(BRT,n=24)。常规组接受常规康复治疗,60分钟/天,6天/周,三个星期。针对URT和BRT增加了上肢机器人辅助康复训练。这是60分钟/天,6天/周,三个星期。主要结果是用Fugl-Meyer-上肢量表(FMA-UE)评估上肢运动功能。次要结局是用改良Barthel指数(MBI)评估的日常生活活动(ADL),运动诱发电位(MEP)评估皮质脊髓束连通性,均方根(RMS)值,并整合表面肌电图记录的肌电图(iEMG)值以评估肌肉收缩功能。
结果:主要结果指标FMA-UE(最小二乘均值(LSMEAN):31.40,95%置信区间(95%CI):27.74-35.07)和次要结果指标MBI(LSMEAN:69.95,95%CI:66.69-73.21)在BRT中显着改善,而不是对照(FMA-UE,LSMEAN:24.79,95%CI:22.23-27.35;MBI,LSMEAN:62.75,95%CI:59.42-66.09);和单边(FMA-UE,LSMEAN:25.97,95%CI:23.57-28.36;MBI,LSMEAN:64.34,95%CI:61.01-67.68)。BRT还显示,在RMS(LSMEAN:257.79,95%CI:211.45-304.12)和iEMG(LSMEAN:202.01,95%CI:167.09-236.94)所示的肌肉收缩功能方面,前三角肌束得到了更大的改善。与对照相比(RMS,LSMEAN:170.77,95%CI:148.97-192.58;iEMG,LSMEAN:132.09,95%CI:114.51-149.68),和URT(RMS,LSMEAN:179.05,95%CI:156.03-202.07;iEMG,LSMEAN:130.38,95%CI:107.50-153.26)。对于任何结果,URT和常规训练之间没有统计学上的显着差异。两组治疗后MEP提取率无显著差异(URTp=0.54,p=0.08对于BRT)。
结论:仅在双侧分娩的情况下,使用针对肘关节和肩部的三维末端执行器对上肢进行60分钟的每日训练,并添加常规康复治疗,似乎可以促进中风患者的上肢功能和ADL。URT似乎没有比传统康复更好的结果。电生理结果表明,使用双侧上肢机器人进行训练可以增加运动神经元的募集,而不是改善皮质脊髓束的传导功能。
OBJECTIVE: To evaluate if bilateral or unilateral upper limb robot-assisted rehabilitation training using a new three-dimensional end-effector robot that targets shoulder and elbow flexion and abduction is superior to conventional therapy with regard to upper extremity motor function recovery and neuromuscular improvement in stroke patients.
METHODS: Randomized, controlled, parallel, assessor-blinded, three-arm clinical trial.
METHODS: Southeast University Zhongda Hospital Nanjing, Jiangsu,
China.
METHODS: Seventy patients with hemiplegic stroke were randomly assigned to conventional training (Control, n = 23) or unilateral (URT, n = 23), or bilateral robotic training (BRT, n = 24). The conventional group received routine rehabilitation, 60 min/day, 6 days/week, for 3 weeks. For URT and BRT upper limb robot-assisted rehabilitation training was added. This was 60 min/day, 6 days/week, for 3 weeks. The primary outcome was upper limb motor function assessed with Fugl-Meyer-Upper Extremity Scale (FMA-UE). Secondary outcomes were activities of daily living (ADL) assessed with the Modified Barthel Index (MBI), Motor Evoked Potential (MEP) to assess corticospinal tract connectivity, Root Mean Square (RMS) value, and integrate Electromyography (iEMG) value recorded by surface electromyography to evaluate muscle contraction function.
RESULTS: The primary outcome indicator FMA-UE (least square mean (LSMEAN): 31.40, 95% confidence interval (95% CI): 27.74-35.07) and the secondary outcome indicator MBI (LSMEAN: 69.95, 95% CI: 66.69-73.21) were significantly improved in BRT as opposed to control (FMA-UE, LSMEAN: 24.79, 95% CI: 22.23-27.35; MBI, LSMEAN: 62.75, 95% CI: 59.42-66.09); and unilateral (FMA-UE, LSMEAN: 25.97, 95% CI: 23.57-28.36; MBI, LSMEAN: 64.34, 95% CI: 61.01-67.68). BRT also showed greater improvement in the anterior deltoid bundle with regard to muscle contraction function indicated by RMS (LSMEAN: 257.79, 95% CI: 211.45-304.12) and iEMG (LSMEAN: 202.01, 95% CI: 167.09-236.94), as compared to the controls (RMS, LSMEAN: 170.77, 95% CI: 148.97-192.58; iEMG, LSMEAN: 132.09, 95% CI: 114.51-149.68), and URT (RMS, LSMEAN: 179.05, 95% CI: 156.03-202.07; iEMG, LSMEAN: 130.38, 95% CI: 107.50-153.26). There was no statistically significant difference between URT and conventional training for any outcome. There was no significant difference in MEP extraction rate after treatment between groups (p = 0.54 for URT, p = 0.08 for BRT).
CONCLUSIONS: A 60 min daily training for upper extremities using a three-dimensional end-effector targeting elbow and shoulder adding conventional rehabilitation appears to promote upper limb function and ADL in stroke patients only if delivered bilaterally. URT does not seem to result in better outcomes than conventional rehabilitation. Electrophysiological results suggest that training using a bilateral upper limb robot increases the recruitment of motor neurons rather than improving the conduction function of the corticospinal tract.