基于正常行走模式的功能性电刺激对脑卒中患者行走功能即时影响的随机对照研究

Immediate effects of functional electrical stimulation based on a normal walking pattern on walking ability of patients with stroke: a randomized controlled trial

目的:通过三维步态分析系统,观察基于正常行走模式的功能性电刺激(FES)对脑卒中患者行走功能的即时影响,为其临床应用及推广提供依据。方法:将符合入组条件的47例脑卒中患者随机分为电刺激组(16例)、安慰电刺激组(15例)和对照组(16例)。电刺激组给予基于正常行走模式设计的四通道FES助行仪治疗,患者戴机行走5min;刺激肌肉分别为偏瘫侧胫前肌、股四头肌、腓肠肌及腘绳肌。安慰电刺激组的电刺激位置及行走时间与电刺激组相同,行走(5min)过程中没有电流输出;对照组不给予电刺激,只让患者行走5min。三组患者分别在治疗前及治疗5min后接受三维步态检查,并对结果进行分析。结果:三组组内治疗后与治疗前比较:电刺激组的步行周期、支撑时间、步行速度、步频、踝背伸角度、踝关节触地时角度均有改善(P<0.05);安慰电刺激组仅在踝关节背伸和踝关节触地时角度有改善(P<0.05);对照组所有参数均无改善,且跨步长缩短、踝关节背伸角度降低(P<0.05)。三组组间比较:治疗后只有触地时踝关节背伸角度差异有显著性意义(P<0.05)。进一步进行治疗前后变化率的组间比较,发现三组患者患侧步行周期、支撑时间、步行速度、步频、步长、跨步长、触地时踝关节背伸角度的差异均有显著性意义(P<0.05)。结论:应用基于正常行走模式的FES治疗5min即可改善脑卒中患者的即时步行功能,长期效果尚待研究。

Objective:In this study,a three-dimensional gait analysis system was applied to observe the immediate effects of FES based on normal gait patterns on the walking function of post-stroke patients, providing a basis for its clinical application. Method: total of 47 subjects were recruited and randomly allocated to a electrical stimulation group (n=16), a placebo-FES group(n=15) or a blank control group(n=16). Subjects in electrical stimulation subgroup received four-channel FES therapy and were asked to walk simultaneously, the electrodes were placed on musculi quadriceps femoris, hamstring tendon, musculi tibialis anterior and musculi gastrocnemius. For placebo-FES group, subjects also received the same four-channel FES therapy as electrical stimulation subgroup but without current output. For the control group, subjects received no FES therapy.Subjects in three groups were asked to walk 5 minutes and 3D gait analysis was conducted before and after 5 minutes’ walk. Result:Intra-group comparison: compared with those before treatment, electrical stimulation group demonstrated improvements in all outcome measurements, including stride time, stance time、mean velocity, cadence, maximum range of ankle, ankle-range of initial contact, while improvements were only observed in maximum range of ankle, ankle-range of initial contraction placebo-FES group and no improvement was observed in blank control group. Group-to-group comparison: Results showed that there was statistical difference in maximum range of ankle. Further, we compared the rate of change with statistical difference including stride time, stancetime, mean velocity, cadence,stride length and ankle-range of initial contact (P<0.05). Conclusion:It’s suggested that normal-gait-patterns-based functional electrical stimulation can improve patients’ walking function immediately, while profound studies are still needed to determine its long-term effect.