Effects of Gait Treatment With a Single-Leg Hybrid Assistive Limb System After Acute Stroke: A Non-randomized Clinical Trial
Effects of Gait Treatment With a Single-Leg Hybrid Assistive Limb System After Acute Stroke: A Non-randomized Clinical Trial
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DOI：
10.3389/fnins.2019.01389
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发表时间：
2020-01-22
影响因子：
4.3
通讯作者：
Matsumura, Akira
中科院分区：
文献类型：
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作者：
Watanabe, Hiroki;Marushima, Aiki;Matsumura, Akira
我们假设，混合辅助肢体(HAL)系统的单腿版本可以改善中风后偏瘫患者的步态和身体功能。因此，在这项先导性研究中，我们比较了基于HAL的步态训练和常规步态训练(CGT)在急性中风患者中的疗效。住进大学医院的患者被分配到HAL组，而那些在同一康复计划下住进外部教学医院但没有使用HAL的患者被分配到对照组。在3周的时间里，所有参与者完成了9次20分钟的步态训练，使用HAL(即偏瘫一侧的HAL的单腿版本)或传统方法(即助行器和步态矫形器)。在九次培训之前和之后对结果进行评估。功能步行分类(FAC)是主要的结果评估指标，但也评估了以下次要结果评估：美国国立卫生研究院卒中评分、Fugl-Meyer评估(下肢)、舒适步行速度、步长、步频、6分钟步行距离、Barthel指数和功能独立性测量。总共有22名中风后参与者完成了临床试验：HAL组12人，CGT组10人。两组均未发生严重不良事件。治疗9次后，HAL组的FAC较CGT组有显著改善(P=0.014)。然而，次要结果在两组之间没有显著差异。我们的结果表明，基于HAL的步态疗法可以改善依赖于步行辅助的急性卒中偏瘫患者的独立行走。需要一项更大规模的随机对照试验来阐明单腿HAL治疗的有效性。
We hypothesized that a single-leg version of the Hybrid Assistive Limb (HAL) system could improve the gait and physical function of patients with hemiparesis following a stroke. In this pilot study, we therefore compared the efficacy of HAL-based gait training with that of conventional gait training (CGT) in patients with acute stroke. Patients admitted to the participating university hospital were assigned to the HAL group, whereas those admitted to outside teaching hospitals under the same rehabilitation program who did not use the HAL were assigned to the control group. Over 3 weeks, all participants completed nine 20 min sessions of gait training, using either HAL (i.e., the single-leg version of HAL on the paretic side) or conventional methods (i.e., walking aids and gait orthoses). Outcome measures were evaluated before and after the nine training sessions. The Functional Ambulation Category (FAC) was the primary outcome measure, but the following secondary outcome measures were also assessed: National Institutes of Health Stroke Scale, Fugl-Meyer Assessment (Lower Extremity), comfortable walking speed, step length, cadence, 6-min walk distance, Barthel Index, and Functional Independence Measure. In total, 22 post-stroke participants completed the clinical trial: 12 in the HAL group and 10 in the CGT group. No serious adverse events occurred in either group. The HAL group showed significant improvement in FAC after nine sessions when compared with the CGT group (P = 0.014). However, secondary outcomes did not differ significantly between the groups. Our results demonstrate that HAL-based gait therapy may improve independent walking in patients with acute stroke hemiplegia who are dependent on ambulatory assistance. A larger-scale randomized controlled trial is needed to clarify the effectiveness of single-leg HAL therapy.