■脑瘫(CP)是儿童最常见的发育性运动障碍。使用可穿戴机器人的机器人辅助步态训练(RAGT)可以提供密集的地面行走体验。
■为了调查地面RAGT在CP儿童中使用无系留,扭矩辅助,可穿戴的外骨骼机器人。
■这个多中心,单盲随机临床试验于2021年9月1日至2023年3月31日在韩国5家康复机构进行.90名患有粗大运动功能分类系统II至IV级CP的儿童被随机分组。
■RAGT组在6周内进行了18次RAGT,而对照组在同一时期接受相同次数的标准物理治疗。
■主要结局指标是粗大运动功能测量88(GMFM-88)评分。次要结局指标是GMFM-66,儿科平衡量表,下肢的选择性控制评估,残疾量表的儿科评估-计算机自适应测试(PEDI-CAT),6分钟步行测试成绩(距离和耗氧量),通过生物电阻抗分析肌肉和脂肪量,和步态参数测量通过三维分析。在基线时对所有患者进行所有评估,在为期6周的干预结束时,在4周的随访之后。
■在90名儿童中(平均[SD]年龄,9.51[2.48]岁;研究中男性49[54.4%],女性41[45.6%]),78人(86.7%)完成干预,有37名参与者(平均[SD]年龄,9.57[2.38]岁;19[51.4%]男性)和41名参与者(平均[SD]年龄,9.32[2.37]岁;26[63.4%]男性)随机分配到RAGT组和对照组,分别。RAGT组的变化显着超过GMFM-88总的对照组的变化(平均差异,2.64;95%CI,0.50-4.78),GMFM-E(平均差,2.70;95%CI,0.08-5.33),GMFM-66(平均差,1.31;95%CI,0.01-2.60),和PEDI-CAT责任域分数(平均差,2.52;95%CI,0.42-4.63),在干预后评估中表明日常生活的独立性。在为期4周的随访中,RAGT组在平衡控制方面表现出显著更大的改善(平均差,1.48;95%CI,0.03-2.94)和步态偏差指数(平均差,6.48;95%CI,2.77-10.19)与对照组相比。
■在这项随机临床试验中,地面RAGT使用可穿戴机器人显着改善粗大运动功能和步态模式。这种新型扭矩辅助可穿戴外骨骼机器人,基于必要的辅助控制,可以通过向CP儿童提供足够的援助和治疗支持来补充标准康复。
■CRIS标识符:KCT0006273。
UNASSIGNED: Cerebral palsy (CP) is the most common developmental motor disorder in children. Robot-assisted gait training (RAGT) using a wearable robot can provide intensive overground walking experience.
UNASSIGNED: To investigate the effectiveness of overground RAGT in children with CP using an untethered, torque-assisted, wearable exoskeletal robot.
UNASSIGNED: This multicenter, single-blind randomized clinical
trial was conducted from September 1, 2021, to March 31, 2023, at 5 rehabilitation institutions in Korea. Ninety children with CP in Gross Motor Function Classification System levels II to IV were randomized.
UNASSIGNED: The RAGT group underwent 18 sessions of RAGT during 6 weeks, whereas the control group received standard physical therapy for the same number of sessions during the same period.
UNASSIGNED: The primary outcome measure was the Gross Motor Function Measure 88 (GMFM-88) score. Secondary outcome measures were the GMFM-66, Pediatric Balance Scale, selective control assessment of the lower extremity, Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), 6-minute walking test scores (distance and oxygen consumption), muscle and fat mass via bioelectrical impedance analysis, and gait parameters measured via 3-dimensional analysis. All assessments were performed for all patients at baseline, at the end of the 6-week intervention, and after the 4-week follow-up.
UNASSIGNED: Of the 90 children (mean [SD] age, 9.51 [2.48] years; 49 [54.4%] male and 41 [45.6%] female) in the
study, 78 (86.7%) completed the intervention, with 37 participants (mean [SD] age, 9.57 [2.38] years; 19 [51.4%] male) and 41 participants (mean [SD] age, 9.32 [2.37] years; 26 [63.4%] male) randomly assigned to the RAGT and control groups, respectively. Changes in the RAGT group significantly exceeded changes in the control group in GMFM-88 total (mean difference, 2.64; 95% CI, 0.50-4.78), GMFM-E (mean difference, 2.70; 95% CI, 0.08-5.33), GMFM-66 (mean difference, 1.31; 95% CI, 0.01-2.60), and PEDI-CAT responsibility domain scores (mean difference, 2.52; 95% CI, 0.42-4.63), indicating independence in daily living at postintervention assessment. At the 4-week follow-up, the RAGT group showed significantly greater improvements in balance control (mean difference, 1.48; 95% CI, 0.03-2.94) and Gait Deviation Index (mean difference, 6.48; 95% CI, 2.77-10.19) compared with the control group.
UNASSIGNED: In this randomized clinical
trial, overground RAGT using a wearable robot significantly improved gross motor function and gait pattern. This new torque-assisted wearable exoskeletal robot, based on assist-as-needed control, may complement standard rehabilitation by providing adequate assistance and therapeutic support to children with CP.
UNASSIGNED: CRIS Identifier: KCT0006273.