穿戴式动力机器人在脑卒中康复中的步态训练：一项随机平行组试验。
Gait training with a wearable powered robot during stroke rehabilitation: a randomized parallel-group trial.
机构信息
Department of Rehabilitation, JA Nagano Koseiren Kakeyu-Misayama Rehabilitation Center Kakeyu Hospital, Ueda, Japan.
Department of Neurology, JA Nagano Koseiren Kakeyu-Misayama Rehabilitation Center Kakeyu Hospital, Ueda, Japan.
出版信息
J Neuroeng Rehabil. 2023 Apr 28;20(1):54. doi: 10.1186/s12984-023-01168-x.
BACKGROUND
We have developed a wearable rehabilitation robot, "curara®," and examined its immediate effect in patients with spinocerebellar degeneration and stroke, but its rehabilitative effect has not been clarified. The purpose of this study was to examine the effect of this device on gait training in stroke patients.
METHODS
Forty stroke patients were enrolled in this study. The participants were divided randomly into two groups (groups A and B). The participants assigned to group A received RAGT with curara® type 4, whereas those in group B received conventional therapist-assisted gait training. The clinical trial period was 15 days. The participants performed 10 sessions of gait training (5 times per week) each lasting 30 ± 5 min per day. The 10-m walking time (10mWT), and 6-minute walking distance (6MWD) were evaluated as the main outcomes. Timed up and go and Berg Balance Scale (BBS) were also examined. Gait parameters (stride duration and length, standard deviation of stride duration and length, cadence, ratio of the stance/swing phases, minimum/maximum knee joint angle, and minimum/maximum hip joint angle) were measured using a RehaGait®. The items other than BBS were measured on days 0, 7, and 14, whereas BBS was measured on days 0 and 14. The improvement rate was calculated as the difference of values between days 14 and 0 divided by the value on day 0. The improvement rates of the 10mWT and 6MWD were set as the main outcomes.
RESULTS
The data of 35 participants were analyzed. There was no significant difference in the main outcomes between both groups at the end of gait training. As for intragroup changes, gait speed, stride length, stride duration, and cadence were improved significantly between days 0 and 14 in each group. When examining the interaction effect between the day of measurement and group, stride duration (p = 0.006) and cadence (p = 0.012) were more significantly improved in group A than in group B.
CONCLUSIONS
This novel wearable powered robot may have the potential to improve gait speed of individuals in stroke rehabilitation.
TRIAL REGISTRATION
Japan Registry of Clinical Trials (jRCTs032180163). Registered on February 22, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs032180163 . UMIN CLINICAL TRIALS REGISTRY (UMIN000034237): Registered on September 22, 2018; https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000038939 .
背景
我们开发了一种可穿戴式康复机器人“curara®”，并在脊髓小脑变性和中风患者中检验了其即时效果，但它的康复效果尚未明确。本研究旨在检验该设备对中风患者步态训练的效果。
方法
本研究纳入了 40 名中风患者。参与者被随机分为两组（A 组和 B 组）。A 组接受 curara®type 4 型的 RAGT，而 B 组接受传统治疗师辅助的步态训练。临床试验期为 15 天。参与者进行 10 次步态训练（每周 5 次），每次 30±5 分钟。10 米步行时间（10mWT）和 6 分钟步行距离（6MWD）为主要结局。还检查了计时起立行走测试和 Berg 平衡量表（BBS）。使用 RehaGait®测量步态参数（步幅时长和长度、步幅时长和长度的标准差、步频、支撑/摆动阶段比、最小/最大膝关节角度、最小/最大髋关节角度）。除 BBS 以外的项目在第 0、7 和 14 天进行测量，而 BBS 在第 0 和 14 天进行测量。将第 14 天与第 0 天之间的差值除以第 0 天的值计算为改善率。10mWT 和 6MWD 的改善率为主要结局。
结果
对 35 名参与者的数据进行了分析。两组在步态训练结束时的主要结局无显著差异。就组内变化而言，两组的步速、步长、步幅时长和步频在第 0 天至第 14 天之间均有显著改善。当检查测量日期和组之间的交互作用时，组 A 的步幅时长（p=0.006）和步频（p=0.012）的改善明显优于组 B。
结论
这种新型可穿戴动力机器人可能有潜力改善中风康复患者的步行速度。
试验注册
日本临床试验注册（jRCTs032180163）。注册于 2019 年 2 月 22 日；https://jrct.niph.go.jp/en-latest-detail/jRCTs032180163。日本临床试验注册（UMIN000034237）：注册于 2018 年 9 月 22 日；https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000038939。
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