机器人辅助步态训练对幕下卒中患者平衡和下肢功能的影响：一项单盲随机对照试验。
Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial.
机构信息
Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Seoul, South Korea.
Department of Rehabilitation Medicine, National Rehabilitation Center, 58, Samgaksan-ro, Gangbuk-gu, Seoul, 01022, Republic of Korea.
出版信息
J Neuroeng Rehabil. 2019 Jul 29;16(1):99. doi: 10.1186/s12984-019-0553-5.
BACKGROUND
Balance impairments are common in patients with infratentorial stroke. Although robot-assisted gait training (RAGT) exerts positive effects on balance among patients with stroke, it remains unclear whether such training is superior to conventional physical therapy (CPT). Therefore, we aimed to investigate the effects of RAGT combined with CPT and compared them with the effects of CPT only on balance and lower extremity function among survivors of infratentorial stroke.
METHODS
This study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation hospital. Patients (n = 19; 16 men, three women; mean age: 47.4 ± 11.6 years) with infratentorial stroke were randomly allocated to either group A (4 weeks of RAGT+CPT, followed by 4 weeks of CPT+CPT) or group B (4 weeks of CPT+CPT followed by 4 weeks of RAGT+CPT). Changes in dynamic and static balance as indicated by Berg Balance Scale scores were regarded as the primary outcome measure. Outcome measures were evaluated for each participant at baseline and after each 4-week intervention period.
RESULTS
No significant differences in outcome-related variables were observed between group A and B at baseline. In addition, no significant time-by-group interactions were observed for any variables, indicating that intervention order had no effect on lower extremity function or balance. Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention.
CONCLUSION
RAGT produces clinically significant improvements in balance and lower extremity function in individuals with infratentorial stroke. Thus, RAGT may be useful for patients with balance impairments secondary to other pathologies.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT02680691. Registered 09 February 2016; retrospectively registered.
背景
平衡障碍在幕下卒中患者中很常见。虽然机器人辅助步态训练（RAGT）对卒中患者的平衡有积极影响，但尚不清楚这种训练是否优于传统的物理疗法（CPT）。因此，我们旨在研究 RAGT 联合 CPT 的效果，并将其与单独使用 CPT 对幕下卒中幸存者的平衡和下肢功能的效果进行比较。
方法
这是一项在一家康复医院进行的单盲、随机对照、交叉设计的研究。将 19 名幕下卒中患者（16 名男性，3 名女性；平均年龄：47.4±11.6 岁）随机分配到 A 组（4 周 RAGT+CPT，然后 4 周 CPT+CPT）或 B 组（4 周 CPT+CPT，然后 4 周 RAGT+CPT）。以 Berg 平衡量表评分表示的动态和静态平衡变化被视为主要的观察指标。在基线和每个 4 周干预期结束时，对每个参与者进行评估。
结果
A 组和 B 组在基线时的结局相关变量无显著差异。此外，任何变量均未观察到时间-分组交互作用，这表明干预顺序对下肢功能或平衡没有影响。RAGT+CPT 干预后，下肢 Fugl-Meyer 评估（FMA-LE）和共济失调评估和评定量表（SARA）等次要功能结果的改善明显大于 CPT+CPT 干预后。
结论
RAGT 可显著改善幕下卒中患者的平衡和下肢功能。因此，RAGT 可能对其他病理引起的平衡障碍患者有用。
试验注册
ClinicalTrials.gov 标识符 NCT02680691。于 2016 年 2 月 9 日注册；回顾性注册。
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