There have been significant advances in the technologies for robot-assisted lower limb rehabilitation in the past decade. However, the development of similar systems for children has been slow despite the fact that children with conditions, such as cerebral palsy, spina bifida, and spinal cord injury (SCI), can benefit greatly from these technologies. Robotic-assisted gait therapy (RAGT) has emerged as a way to increase gait training duration and intensity while decreasing the risk of injury to therapists. Robotic walking devices can be coupled with motion sensing, electromyography, scalp electroencephalography, or other noninvasive methods of acquiring information about the user's intent to design brain–computer interfaces (BCI) for neuromuscular rehabilitation and control of powered exoskeletons. For users with SCI, BCIs could provide a method of overground mobility closer to the natural process of the brain controlling the body's movement during walking than mobility by wheelchair. For adults, there are currently four Food and Drug Administration (FDA) approved lower limb exoskeletons that could be incorporated into such a BCI system, but there are no similar devices specifically designed for children, who present additional physical, neurological, and cognitive developmental challenges. The current state-of-the-art for pediatric RAGT relies on large clinical devices with high costs that limit accessibility. This can reduce the amount of therapy a child receives and slow the rehabilitation progress. In many cases, the lack of gait training can result in a reduction in the mobility, independence, and overall quality of life for children with lower limb disabilities. Thus, it is imperative to facilitate and accelerate the development of pediatric technologies for gait rehabilitation, including their regulatory path. In this article, an overview of the U.S. FDA clearance/approval process is presented. An example device has been used to navigate important questions facing device developers focused on providing lower limb rehabilitation to children in home based or other settings beyond the clinic.

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为儿科下肢外骨骼器械导航 FDA 医疗器械监管途径

在过去十年中，机器人辅助下肢康复技术取得了重大进展。然而，尽管患有脑瘫、脊柱裂和脊髓损伤 (SCI) 等疾病的儿童可以从这些技术中受益匪浅，但针对儿童的类似系统的开发却进展缓慢。机器人辅助步态治疗 (RAGT) 已成为一种增加步态训练持续时间和强度，同时降低治疗师受伤风险的方法。机器人步行设备可以与运动传感、肌电图、头皮脑电图或其他非侵入性方法相结合，以获取有关用户设计脑机接口 (BCI) 意图的信息，用于神经肌肉康复和动力外骨骼控制。对于有SCI的用户，BCI 可以提供一种地面移动方法，它更接近于大脑在步行过程中控制身体运动的自然过程，而不是轮椅移动。对于成年人来说，目前有四种食品和药物管理局 (FDA) 批准的下肢外骨骼可以整合到这种 BCI 系统中，但没有专门为儿童设计的类似设备，他们会带来额外的身体、神经和认知发育挑战. 目前儿科 RAGT 的最新技术依赖于成本高昂的大型临床设备，这限制了可及性。这可以减少孩子接受的治疗量并减缓康复进程。在许多情况下，缺乏步态训练会导致活动能力、独立性、和下肢残疾儿童的整体生活质量。因此，必须促进和加速儿科步态康复技术的发展，包括其监管路径。在本文中，概述了美国 FDA 的批准/批准过程。一个示例设备已被用于解决设备开发人员面临的重要问题，这些问题专注于为在家中或诊所以外的其他环境中的儿童提供下肢康复。