A randomized controlled trial of an implantable 2-channel peroneal nerve stimulator on walking speed and activity in poststroke hemiplegia
A randomized controlled trial of an implantable 2-channel peroneal nerve stimulator on walking speed and activity in poststroke hemiplegia
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DOI：
10.1016/j.apmr.2007.05.002
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发表时间：
2007-08-01
影响因子：
4.3
通讯作者：
IJzerman, Maarten J.
中科院分区：
文献类型：
--
作者：
Kottink, Anke I.;Hermens, Hermie J.;IJzerman, Maarten J.
目的：探讨一种新型植入式2通道腓神经刺激器对慢性脑卒中落足患者步行速度和日常活动的影响，并与常规治疗方法进行比较。设计：随机对照试验。设置：所有受试者在步态实验室测量5次。参与者：29名中风幸存者，慢性偏瘫伴下垂足，符合预先设定的纳入和排除标准。干预：干预组接受植入式2通道腓神经刺激器矫治下垂足。对照组继续使用传统的步行设备，包括踝足矫形器、矫形鞋或不使用任何设备。主要结局指标：通过6分钟步行测试（6MWT）和10米步行测试评估的步行速度被选为主要结局指标，活动监测数据，包括行走、站立和坐/躺的时间百分比被选为次要结局指标。结果：功能性电刺激（FES）使6MWT测量的步行速度提高23%，而对照组的改善仅为3% （P= 0.010）。在10米人行道上测量的舒适步行速度也显著改善，有利于FES （P= 0.038）。踏步时间百分比下降，干预组为3%，对照组为0.8%，两组差异无统计学意义（P= 0.13）。结论：本研究显示了可植入的2通道腓神经刺激器对脑卒中幸存者步行速度的临床相关影响。
Objective: To determine the effect of a new implantable 2-channel peroneal nerve stimulator on walking speed and daily activities, in comparison with the usual treatment in chronic stroke survivors with a drop foot.Design: Randomized controlled trial.Setting: All subjects were measured 5 times in the gait laboratory.Participants: Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfill the predefined inclusion and exclusion criteria were included in the study.Intervention: The intervention group received an implantable 2-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device.Main Outcome Measures: Walking speed, assessed both by a six-minute walk test (6MWT) and by using a 10-m walkway, was selected as primary outcome measure and activity monitoring data, consisting of percentage time spent on stepping, standing, and sitting/lying were selected as secondary outcome measure.Results: Functional electric stimulation (FES) resulted in a 23% improvement of walking speed measured with the 6MWT, whereas the improvement in the control group was only 3% (P=.010). Comfortable walking speed measured on a 10-m walkway was also significantly improved in favor of FES (P=.038). The percentage time spent on stepping deteriorated with 3% in the intervention and 0.8% in control group, which was not statistically significant between both groups (P=.13).Conclusions: The present study shows a clinically relevant effect of the implantable 2-channel peroneal nerve stimulator on walking speed in the sample of stroke survivors included in our study.