A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton - The HALESTRO Study (HAL-Exoskeleton STROke Study)
A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton - The HALESTRO Study (HAL-Exoskeleton STROke Study)
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DOI：
10.3389/fnins.2019.00259
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发表时间：
2019-03-29
影响因子：
4.3
通讯作者：
Tegenthoff, Martin
中科院分区：
文献类型：
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作者：
Sczesny-Kaiser, Matthias;Trost, Rebecca;Tegenthoff, Martin
背景：外骨骼 HAL（混合辅助肢）已被证明在用于体重支撑跑步机训练（BWSTT）时可以改善脊髓损伤和慢性中风患者的步行功能。与其他机器人设备相比，它提供了主动发起运动的可能性。之前针对中风患者的研究并未将 HAL-BWSTT 与传统物理疗法 (CPT) 进行比较。因此，我们进行了一项交叉临床试验，即 HALESTRO 研究，比较 CPT 和 HAL-BWSTT 在慢性中风偏瘫患者中的作用。我们的假设是，与混合方法 CPT 相比，HAL 训练对步行和姿势功能有更大的影响。方法：共有 18 名慢性中风患者参与了这项研究。治疗包括 30 次 CPT 疗程和 30 次 BWSTT 疗程，采用双腿型 HAL 外骨骼，采用随机交叉研究设计。主要结果参数是 10 米步行测试 (10MWT) 中的步行时间和速度、定时启动测试 (TUG) 中的时间以及 6 分钟步行测试 (6MWT) 中的距离。次要结果参数是功能性步行类别（FAC）和伯格平衡量表（BBS）。在基线、交叉和研究结束时对数据进行评估，所有这些都没有使用和佩戴 HAL。 结果：我们的研究表明步行参数以及功能和平衡参数均没有显着差异。当 HAL-BWSTT 应用于初次接受治疗的患者时，步行参数和平衡能力得到改善。汇总所有数据，我们可以显示 10MVVT、6MWT、FAC 和 BBS 的显着效果，这两种疗法连续应用超过 12 周。因此，FAC 从依赖类别改进为独立类别（3 至 4）。一名患者因每次训练后严重疲劳而退出研究。结论：HAL-BWSTT 和混合方法 CPT 是慢性卒中患者的有效治疗方法。然而，与CPT相比，6周30次的HAL培训并没有更有效。两种疗法的结合改善了步行和平衡功能。仅针对步行障碍的机器人康复仍缺乏治疗慢性中风优越性的证据。机器人治疗疗法和经典的 CPT 康复概念应应用于个体化治疗计划。
Background: The exoskeleton HAL (hybrid assistive limb) has proven to improve walking functions in spinal cord injury and chronic stroke patients when using it for body-weight supported treadmill training (BWSTT). Compared with other robotic devices, it offers the possibility to initiate movements actively. Previous studies on stroke patients did not compare HAL-BWSTT with conventional physiotherapy (CPT). Therefore, we performed a crossover clinical trial comparing CPT and HAL-BWSTT in chronic stroke patients with hemiparesis, the HALESTRO study. Our hypothesis was that HAL-training would have greater effects on walking and posture functions compared to a mixed-approach CPT.Methods: A total of 18 chronic stroke patients participated in this study. Treatment consisted of 30 CPT sessions and of 30 sessions of BWSTT with a double leg type HAL exoskeleton successively in a randomized, crossover study design. Primary outcome parameters were walking time and speed in 10-meter walk test (10MWT), time in timedup-and-go test (TUG) and distance in 6-min walk test (6MWT). Secondary outcome parameters were the functional ambulatory categories (FAC) and the Berg-Balance Scale (BBS). Data were assessed at baseline, at crossover and at the end of the study, all without using and wearing HAL.Results: Our study demonstrate neither a significant difference in walking parameters nor in functional and balance parameters. When HAL-BWSTT was applied to naive patients, it led to an improvement in walking parameters and in balance abilities. Pooling all data, we could show a significant effect in 10MVVT, 6MWT, FAC and BBS, both therapies sequentially applied over 12 weeks. Thereby, FAC improve from dependent to independent category (3 to 4). One patient dropped out of the study due to intensive fatigue after each training session.Conclusion: HAL-BWSTT and mixed-approach CPT were effective therapies in chronic stroke patients. However, compared with CPT, HAL training with 30 sessions over 6 weeks was not more effective. The combination of both therapies led to an improvement of walking and balance functions. Robotic rehabilitation of walking disorders alone still lacks the proof of superiority in chronic stroke. Robotic treatment therapies and classical CPT rehabilitation concepts should be applied in an individualized therapy program.