PDF(Pubmed)
Abstract：
UNASSIGNED: Early phase research suggests that physiotherapy paired with use of robotic walking aids provides a novel opportunity for children with severe mobility challenges to experience active walking. The Trexo Plus is a pediatric lower limb exoskeleton mounted on a wheeled walker frame, and is adjustable to fit a child\'s positional and gait requirements. It guides and powers the child\'s leg movements in a way that is individualized to their movement potential and upright support needs, and can provide progressive challenges for walking within a physiotherapy-based motor learning treatment paradigm.
UNASSIGNED: This protocol outlines a single group mixed-methods study that assesses the feasibility of physiotherapy-assisted overground Trexo use in school and outpatient settings during a 6-week physiotherapy block. Children ages 3-6 years (n = 10; cerebral palsy or related disorder, Gross Motor Function Classification System level IV) will be recruited by circle of care invitations to participate. Study indicators/outcomes will focus on evaluation of: (i) clinical feasibility, safety, and acceptability of intervention; (ii) pre-post intervention motor/functional outcomes; (iii) pre-post intervention brain structure characterization and resting state brain connectivity; (iv) muscle activity characterization during Trexo-assisted gait and natural assisted gait; (v) heart rate during Trexo-assisted gait and natural assisted gait; and (vi) user experience and perceptions of physiotherapists, children, and parents.
UNASSIGNED: This will be the first study to investigate feasibility indicators, outcomes, and experiences of Trexo-based physiotherapy in a school and outpatient context with children who have mobility challenges. It will explore the possibility of experience-dependent neuroplasticity in the context of gait rehabilitation, as well as associated functional and muscular outcomes. Finally, the study will address important questions about clinical utility and future adoption of the device from the physiotherapists\' perspective, comfort and engagement from the children\'s perspective, and the impressions of parents about the value of introducing this technology as an early intervention.
UNASSIGNED: https://clinicaltrials.gov, identifier NCT05463211.
UNASSIGNED: This protocol outlines a single group mixed-methods study that assesses the feasibility of physiotherapy-assisted overground Trexo use in school and outpatient settings during a 6-week physiotherapy block. Children ages 3-6 years (n = 10; cerebral palsy or related disorder, Gross Motor Function Classification System level IV) will be recruited by circle of care invitations to participate. Study indicators/outcomes will focus on evaluation of: (i) clinical feasibility, safety, and acceptability of intervention; (ii) pre-post intervention motor/functional outcomes; (iii) pre-post intervention brain structure characterization and resting state brain connectivity; (iv) muscle activity characterization during Trexo-assisted gait and natural assisted gait; (v) heart rate during Trexo-assisted gait and natural assisted gait; and (vi) user experience and perceptions of physiotherapists, children, and parents.
UNASSIGNED: This will be the first study to investigate feasibility indicators, outcomes, and experiences of Trexo-based physiotherapy in a school and outpatient context with children who have mobility challenges. It will explore the possibility of experience-dependent neuroplasticity in the context of gait rehabilitation, as well as associated functional and muscular outcomes. Finally, the study will address important questions about clinical utility and future adoption of the device from the physiotherapists\' perspective, comfort and engagement from the children\'s perspective, and the impressions of parents about the value of introducing this technology as an early intervention.
UNASSIGNED: https://clinicaltrials.gov, identifier NCT05463211.
摘要：
■早期研究表明，物理治疗与机器人助行器的使用相结合，为患有严重行动不便的儿童提供了一个新的机会来体验主动行走。TrexoPlus是安装在轮式助行器框架上的小儿下肢外骨骼，并且可以调整以适合孩子的位置和步态要求。它以个性化的方式引导和驱动孩子的腿部运动，以适应他们的运动潜力和直立支持需求，并且可以为基于物理治疗的运动学习治疗范式中的行走提供渐进的挑战。
■该方案概述了一项单组混合方法研究，该研究评估了在为期6周的物理治疗期间在学校和门诊环境中使用物理治疗辅助地面Trexo的可行性。3-6岁儿童（n=10；脑瘫或相关疾病，粗大运动功能分类系统IV级）将通过护理邀请圈招募参加。研究指标/结果将侧重于评估：(I)临床可行性，安全,和干预的可接受性；（ii）干预前的运动/功能结果；（iii）干预前的脑结构表征和静息状态脑连通性；（iv）Trexo辅助步态和自然辅助步态期间的肌肉活动表征；（v）Trexo辅助步态和自然辅助步态期间的心率；（vi）物理治疗师的用户体验和感知，孩子们,和父母。
■这将是第一个调查可行性指标的研究，结果，以及在学校和门诊环境中对行动不便的儿童进行基于Trexo的物理治疗的经验。它将在步态康复的背景下探索经验依赖性神经可塑性的可能性，以及相关的功能和肌肉结果。最后,该研究将从物理治疗师的角度解决有关该设备的临床实用性和未来采用的重要问题，从儿童的角度来看，舒适和参与，以及父母对引入这项技术作为早期干预的价值的印象。
■https://clinicaltrials.gov,标识符NCT05463211。
■该方案概述了一项单组混合方法研究，该研究评估了在为期6周的物理治疗期间在学校和门诊环境中使用物理治疗辅助地面Trexo的可行性。3-6岁儿童（n=10；脑瘫或相关疾病，粗大运动功能分类系统IV级）将通过护理邀请圈招募参加。研究指标/结果将侧重于评估：(I)临床可行性，安全,和干预的可接受性；（ii）干预前的运动/功能结果；（iii）干预前的脑结构表征和静息状态脑连通性；（iv）Trexo辅助步态和自然辅助步态期间的肌肉活动表征；（v）Trexo辅助步态和自然辅助步态期间的心率；（vi）物理治疗师的用户体验和感知，孩子们,和父母。
■这将是第一个调查可行性指标的研究，结果，以及在学校和门诊环境中对行动不便的儿童进行基于Trexo的物理治疗的经验。它将在步态康复的背景下探索经验依赖性神经可塑性的可能性，以及相关的功能和肌肉结果。最后,该研究将从物理治疗师的角度解决有关该设备的临床实用性和未来采用的重要问题，从儿童的角度来看，舒适和参与，以及父母对引入这项技术作为早期干预的价值的印象。
■https://clinicaltrials.gov,标识符NCT05463211。
