Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT)
Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT)
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DOI：
10.1186/s12887-017-0815-y
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发表时间：
2017-03-02
期刊：
影响因子：
2.4
通讯作者：
van Hedel, H. J. A.
中科院分区：
文献类型：
--
作者：
Ammann-Reiffer, C.;Bastiaenen, C. H. G.;van Hedel, H. J. A.
背景：在考虑治疗干预的重要领域时，步行能力是许多脑瘫 (CP) 儿童及其父母的首要考虑因素。部分体重支持的跑步机训练已成为满足这一需求的既定治疗方法。此外，新的机器人康复技术越来越多地在临床环境中实施，以允许更长的训练时间和增加的步骤重复次数，同时保持一致的运动模式。但目前关于其在儿科康复中的临床有效性的证据还很薄弱。因此，该研究项目的目的是调查机器人辅助步态训练对改善脑瘫儿童功能性步态参数的有效性。方法/设计：将在瑞士的两个儿科治疗中心招募6至18岁患有双侧痉挛性脑瘫的儿童，这些儿童无论有或没有助行器都能够行走至少14 m。在采用随机治疗顺序的务实交叉设计中，他们进行 5 周的机器人辅助步态训练（每周 3 次，每次步行时间最多 45 分钟）或 5 周的标准治疗期，根据儿童的需求单独定制，通常包括每周 1-2 次物理治疗以及额外的马术治疗、循环训练以及必要时的职业治疗。两种干预措施均在门诊环境中进行。在每个干预期之前和结束时，评估粗大运动功能测量 88 (GMFM-88) 维度 E 的百分比分数作为主要结果，以及 GMFM-88 维度 D、6 分钟和 10 米步行测试作为次要结果。此外，还为首先分配接受标准治疗的儿童安排了为期 5 周的随访评估。通过配对分析来分析治疗效果、期间效果以及随访效果，并使用独立的测试统计数据来评估残留效应。讨论：尽管机器人辅助步态训练已成为解决步态障碍的既定治疗选择，但其有效性的证据尚不清楚。这项务实的试验将提供有关其在临床门诊条件下的效果的重要信息。
Background: Walking ability is a priority for many children with cerebral palsy (CP) and their parents when considering domains of importance regarding treatment interventions. Partial body-weight supported treadmill training has become an established therapeutic treatment approach to address this demand. Further, new robotic rehabilitation technologies have increasingly been implemented in the clinical setting to allow for longer training sessions with increased step repetitions while maintaining a consistent movement pattern. But the current evidence about its clinical effectiveness in pediatric rehabilitation is weak. The aim of this research project is therefore to investigate the effectiveness of robot-assisted gait training on improvements of functional gait parameters in children with cerebral palsy.Methods/Design: Children aged 6 to 18 years with bilateral spastic cerebral palsy who are able to walk at least 14 m with or without walking aids will be recruited in two pediatric therapy centers in Switzerland. Within a pragmatic cross-over design with randomized treatment sequences, they perform 5 weeks of robot-assisted gait training (three times per week with a maximum of 45 min walking time each) or a 5-week period of standard treatment, which is individually customized to the needs of the child and usually consists of 1-2 sessions of physiotherapy per week and additional hippotherapy, circuit training as well as occupational therapy as necessary. Both interventions take place in an outpatient setting. The percentage score of the dimension E of the Gross Motor Function Measure-88 (GMFM-88) as primary outcome as well as the dimension D of the GMFM-88, 6-minute and 10-meter walking tests as secondary outcomes are assessed before and at the end of each intervention period. Additionally, a 5-week follow-up assessment is scheduled for the children who are assigned to the standard treatment first. Treatment effects, period effects as well as follow-up effects are analyzed with paired analyses and independent test statistics are used to assess carry-over effects.Discussion: Although robot-assisted gait training has become an established treatment option to address gait impairments, evidence for its effectiveness is vague. This pragmatic trial will provide important information on its effects under clinical outpatient conditions.