PDF(Pubmed)
Abstract：
OBJECTIVE: The objective of this study was to analyze the safety and efficacy of using a robotic hip exoskeleton designed by Samsung Electronics Co., Ltd., Korea, called the Gait Enhancing and Motivating System-Hip (GEMS-H), in assistance mode only with the poststroke population in an outpatient-rehabilitation setting.
METHODS: Forty-one participants with an average age of 60 and average stroke latency of 6.5 years completed this prospective, single arm, interventional, longitudinal study during the COVID-19 pandemic. Significant modifications to the traditional outpatient clinical environment were made to adhere to organizational physical distancing policies as well as guidelines from the Centers for Disease Control. All participants received gait training with the GEMS-H in assistance mode for 18 training sessions over the course of 6-8 weeks. Performance-based and self-reported clinical outcomes were assessed at four time points: baseline, midpoint (after 9 training sessions), post (after 18 training sessions), and 1-month follow up. Daily step count was also collected throughout the duration of the study using an ankle-worn actigraphy device. Additionally, corticomotor excitability was measured at baseline and post for 4 bilateral lower limb muscles using transcranial magnetic stimulation.
RESULTS: By the end of the training program, the primary outcome, walking speed, improved by 0.13 m/s (p < 0.001). Secondary outcomes of walking endurance, balance, and functional gait also improved as measured by the 6-Minute Walk Test (47 m, p < 0.001), Berg Balance Scale (2.93 points, p < 0.001), and Functional Gait Assessment (1.80 points, p < 0.001). Daily step count significantly improved with and average increase of 1,750 steps per day (p < 0.001). There was a 35% increase in detectable lower limb motor evoked potentials and a significant decrease in the active motor threshold in the medial gastrocnemius (-5.7, p < 0.05) after training with the device.
CONCLUSIONS: Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke. Day-to-day activity also improved as evidenced by increased daily step count. Additionally, corticomotor excitability changes suggest that training with this device may help correct interhemispheric imbalance typically seen after stroke.
BACKGROUND: This study is registered with ClinicalTrials.gov (NCT04285060).
METHODS: Forty-one participants with an average age of 60 and average stroke latency of 6.5 years completed this prospective, single arm, interventional, longitudinal study during the COVID-19 pandemic. Significant modifications to the traditional outpatient clinical environment were made to adhere to organizational physical distancing policies as well as guidelines from the Centers for Disease Control. All participants received gait training with the GEMS-H in assistance mode for 18 training sessions over the course of 6-8 weeks. Performance-based and self-reported clinical outcomes were assessed at four time points: baseline, midpoint (after 9 training sessions), post (after 18 training sessions), and 1-month follow up. Daily step count was also collected throughout the duration of the study using an ankle-worn actigraphy device. Additionally, corticomotor excitability was measured at baseline and post for 4 bilateral lower limb muscles using transcranial magnetic stimulation.
RESULTS: By the end of the training program, the primary outcome, walking speed, improved by 0.13 m/s (p < 0.001). Secondary outcomes of walking endurance, balance, and functional gait also improved as measured by the 6-Minute Walk Test (47 m, p < 0.001), Berg Balance Scale (2.93 points, p < 0.001), and Functional Gait Assessment (1.80 points, p < 0.001). Daily step count significantly improved with and average increase of 1,750 steps per day (p < 0.001). There was a 35% increase in detectable lower limb motor evoked potentials and a significant decrease in the active motor threshold in the medial gastrocnemius (-5.7, p < 0.05) after training with the device.
CONCLUSIONS: Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke. Day-to-day activity also improved as evidenced by increased daily step count. Additionally, corticomotor excitability changes suggest that training with this device may help correct interhemispheric imbalance typically seen after stroke.
BACKGROUND: This study is registered with ClinicalTrials.gov (NCT04285060).
摘要：
目的：本研究的目的是分析使用三星电子公司设计的机器人髋关节外骨骼的安全性和有效性。Ltd.,韩国,称为步态增强和激励系统-髋关节(GEMS-H)，仅在门诊康复环境中的卒中后人群处于辅助模式。
方法：41名平均年龄为60岁、平均卒中潜伏期为6.5年的参与者完成了这项前瞻性研究，单臂,介入,COVID-19大流行期间的纵向研究。对传统的门诊临床环境进行了重大修改，以遵守组织的身体距离政策以及疾病控制中心的指导方针。所有参与者都接受了GEMS-H的步态训练，在6-8周的过程中进行了18次训练。在四个时间点评估基于性能和自我报告的临床结果：基线，中点(在9次培训课程之后)，员额(18次培训课程后)，并随访1个月。在整个研究过程中，每天的步数也使用踝部佩戴的活动描记术设备进行收集。此外,使用经颅磁刺激在基线和术后测量4条双侧下肢肌肉的皮质运动兴奋性。
结果：在培训计划结束时，主要结果,步行速度,提高了0.13m/s(p<0.001)。步行耐力的次要结果，balance,通过6分钟步行测试（47m，p<0.001)，伯格平衡量表(2.93分，p<0.001)，和功能步态评估(1.80分，p<0.001)。每日步数显着改善，平均每天增加1,750步（p<0.001）。在用该装置训练后,可检测到的下肢运动诱发电位增加35%,腓肠肌内侧的主动运动阈值显著降低(-5.7,p<0.05)。
结论：使用GEMS-H外骨骼进行的步态训练显示出步行速度的显着改善，行走耐力，慢性中风患者的平衡。日常活动也得到改善,如增加的每日步数所证明的。此外,皮质运动兴奋性变化表明，使用该设备进行训练可能有助于纠正中风后通常出现的半球间失衡。
背景：本研究已在ClinicalTrials.gov（NCT04285060）注册。
方法：41名平均年龄为60岁、平均卒中潜伏期为6.5年的参与者完成了这项前瞻性研究，单臂,介入,COVID-19大流行期间的纵向研究。对传统的门诊临床环境进行了重大修改，以遵守组织的身体距离政策以及疾病控制中心的指导方针。所有参与者都接受了GEMS-H的步态训练，在6-8周的过程中进行了18次训练。在四个时间点评估基于性能和自我报告的临床结果：基线，中点(在9次培训课程之后)，员额(18次培训课程后)，并随访1个月。在整个研究过程中，每天的步数也使用踝部佩戴的活动描记术设备进行收集。此外,使用经颅磁刺激在基线和术后测量4条双侧下肢肌肉的皮质运动兴奋性。
结果：在培训计划结束时，主要结果,步行速度,提高了0.13m/s(p<0.001)。步行耐力的次要结果，balance,通过6分钟步行测试（47m，p<0.001)，伯格平衡量表(2.93分，p<0.001)，和功能步态评估(1.80分，p<0.001)。每日步数显着改善，平均每天增加1,750步（p<0.001）。在用该装置训练后,可检测到的下肢运动诱发电位增加35%,腓肠肌内侧的主动运动阈值显著降低(-5.7,p<0.05)。
结论：使用GEMS-H外骨骼进行的步态训练显示出步行速度的显着改善，行走耐力，慢性中风患者的平衡。日常活动也得到改善,如增加的每日步数所证明的。此外,皮质运动兴奋性变化表明，使用该设备进行训练可能有助于纠正中风后通常出现的半球间失衡。
背景：本研究已在ClinicalTrials.gov（NCT04285060）注册。
