Introduction

Exercise therapy and neuromuscular electrical stimulation (NMES) during the initial 14 days after stroke may benefit recovery of gait. We aimed to determine whether poststroke NMES of vastus medial and tibial muscles during exercise therapy is more effective than exercise therapy alone.

Materials and methods

In this proof-of-concept randomised trial patients with first-ever acute ischemic stroke and a leg paresis (40–85 years of age) were randomised (1:1) to 10 min of daily NMES + exercise therapy or exercise therapy alone. Primary outcome was the between-group difference in change in 6 min Walk Test (6MWT) at 90 days post stroke estimated with a mixed regression model. Secondary outcomes included 10 m Walk Test, Fugl-Meyer Motor Assessment, Guralnik Timed Standing Balance, Sit to Stand, Timed Up and Go, EQ-5D-5L, Montreal Cognitive Assessment and Becks Depression Inventory.

Results

50 stroke survivors (25 in each group) with a mean age of 67 years (range 43–83) were included. An insignificant between-group difference in change of 28.3 m (95%CI -16.0 to 72.6, p = 0.23, adjusted for baseline) in 6MWT at 90-days follow-up was found, in favour of the NMES group. All secondary outcomes showed no statistically significant between-group difference. The conclusion was that adding NMES to exercise therapy had no effect on poststroke walking distance measured by the 6 MWT or any of the secondary outcomes.

Conclusions

In this proof-of-concept RCT, we demonstrated that NMES in addition to exercise therapy during the first 14 days after onset of ischemic stroke did not improve walking distance or any of the secondary outcomes. Future studies with a longer trial period, stratifying patients into subgroups with comparable patterns of expected spontaneous recovery – if possible within 48 h post stroke, and greater sample size, than in this study are suggestions of how rehabilitation research could go on exploring the potential for NMES as an amplifier in stroke recovery.

中文翻译：

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神经肌肉电刺激在急性缺血性中风引起的下肢麻痹患者的运动疗法之外。

介绍

中风后最初 14 天内的运动疗法和神经肌肉电刺激 (NMES) 可能有益于步态的恢复。我们的目的是确定运动疗法期间股内侧和胫骨肌肉的卒中后 NMES 是否比单独运动疗法更有效。

材料和方法

在这项概念验证随机试验中，首次患有急性缺血性中风和腿部麻痹的患者（40-85 岁）被随机分配 (1:1) 接受每天 10 分钟的 NMES + 运动疗法或单独运动疗法。主要结果是使用混合回归模型估计的卒中后 90 天 6 分钟步行测试 (6MWT) 变化的组间差异。次要结果包括 10 米步行测试、Fugl-Meyer 运动评估、Guralnik 计时站立平衡、坐到站、计时起走、EQ-5D-5L、蒙特利尔认知评估和 Becks 抑郁量表。

结果

50 名平均年龄为 67 岁（范围 43-83 岁）的中风幸存者（每组 25 名）被纳入。 发现在 90 天随访时 6MWT的 28.3 m（95%CI -16.0 至 72.6， p = 0.23，根据基线调整）变化的组间差异不显着，有利于 NMES 组。所有次要结果均未显示具有统计学意义的组间差异。结论是，在运动疗法中加入 NMES 对 6 MWT 测量的卒中后步行距离或任何次要结果没有影响。

结论

在此概念验证 RCT 中，我们证明了在缺血性中风发作后的前 14 天内，除了运动疗法外，NMES 并未改善步行距离或任何次要结果。未来的研究具有更长的试验期，将患者分为具有可比的预期自发恢复模式的亚组——如果可能的话，在中风后 48 小时内进行，并且样本量比本研究更大，这些都是康复研究如何继续探索潜在康复的建议NMES 作为中风恢复的放大器。