Development of a robotic ankle assist device to improve mobility in individuals with movement disorders.

开发机器人脚踝辅助装置，以改善运动障碍患者的活动能力。

• 批准号: 10418884
• 负责人: RAYMOND Clifton BROWNING
• 金额: $ 88.46万
• 依托单位: BIOMOTUM, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10418884
• 关键词: Development; robotic; ankle; assist; device

PROJECT SUMMARY/ABSTRACT A child’s ability to engage in physical activity is essential to their health, independence, and general well-being. Many of the 500k children in the United States with cerebral palsy (CP), the most common cause of pediatric physical disability, have difficulty walking and participating in physical activity. This reduced physical activity in CP is a primary contributor to the greater incidence of metabolic dysfunction, cardiovascular disease, osteoporosis, pain, and diminished psycho-social quality of life. Unfortunately, half of all ambulatory children with CP lose the ability to walk independently in adulthood, indicating that the current approaches for treating these individuals do not result in meaningfully improved mobility over time. Physical Therapy (PT) is essential for treating CP but the amount of PT is generally insufficient, and the delivery of PT can be inefficient. There is currently no viable way to provide a sufficient dose of PT that will lead to long-term improvements in mobility and reduce the negative physical and social outcomes noted above. BiOMOTUM’s (applicant) goal is to create a reimbursable wearable system for children with CP that will (1) make walking easier and improve free-living mobility, (2) increase the dose and precision of ankle plantar-flexor therapy to produce lasting improvements in neuromuscular function, and (3) create a virtual community to incentivize the use of the system and track improvement. To achieve these goals, this project uses a lightweight, low-profile, battery-powered, wearable Robotic Ankle Assistive Device (RAAD). The overall objectives of this proposal are to establish feasibility of the RAAD system to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy. The first specific aim is to complete a personal-use feasibility analysis of ankle mobility assistance. It is hypothesized the children will be able to safely walk faster and travel farther in the community when using the RAAD device vs. without the device. The second specific aim is to gather feedback to design and prototype a minimum viable product for use in clinical and community settings. The third specific aim is to quantify the potential for the RAAD system to increase the effectiveness of clinical gait therapy. Individuals with CP will complete three training sessions: RAAD assistance, RAAD resistance and standard of care. Muscle activity and step activity will be measured during each session. It is hypothesized that the RAAD assistance and resistance therapy will improve ankle plantar-flexor muscle activity and treatment session quality compared to traditional physical therapist-guided gait training. The fourth specific aim is to assess the benefits of repeated gait training with RAAD assistance and resistance. Individuals with CP will participate in a 4-week assistance or resistance intervention and mobility outcomes will be quantified pre and post intervention. It is hypothesized that both assistance and resistance training will improve mobility outcomes. This proposal paves the way for commercializing the device and implementing future longitudinal interventions that will investigate the potential for RAAD to improve quality of life and long-term clinical outcomes.

项目总结/摘要 儿童从事体育活动的能力对他们的健康、独立性和总体福祉至关重要。 在美国，50万儿童中有许多患有脑瘫（CP），这是小儿麻痹症最常见的原因。 身体残疾，行走和参加体育活动有困难。这减少了体力活动， CP是导致代谢功能障碍、心血管疾病 骨质疏松症、疼痛和心理社会生活质量下降。不幸的是，一半的流动儿童， CP在成年后失去了独立行走的能力，这表明目前治疗这些疾病的方法 随着时间的推移，个人并没有带来有意义的改善的流动性。物理治疗（PT）是必不可少的， 治疗CP，但PT的量通常不足，并且PT的递送可能是低效的。有 目前没有可行的方法来提供足够剂量的PT，这将导致长期改善流动性， 减少上述负面的身体和社会后果。BioMOTUM（申请人）的目标是创建一个 为脑瘫儿童提供可报销的可穿戴系统，该系统将（1）使行走更容易，并改善自由生活 活动性，（2）增加踝跖屈肌治疗的剂量和精度，以产生持久的改善， 神经肌肉功能，和（3）创建一个虚拟社区，以激励系统的使用和跟踪 改进.为了实现这些目标，该项目使用了一种轻便、低姿态、电池供电、可穿戴的 机器人踝关节辅助装置（RAAD）。本提案的总体目标是确定 RAAD系统，以改善自由生活环境中的流动性，并将RAAD确立为提供 增加了针对性踝关节治疗的剂量和精度。第一个具体目标是完成个人使用 踝关节活动辅助的可行性分析。据推测，孩子们将能够安全地走得更快 并且在使用RAAD设备与不使用该设备时在社区中行进得更远。第二特定 目的是收集反馈意见，设计和原型最低可行的产品，用于临床和社区 设置.第三个具体目标是量化RAAD系统提高以下方面的有效性的潜力： 临床步态治疗CP患者将完成三个培训课程：RAAD援助，RAAD 抵抗力和护理标准。肌肉活动和步活动将在每次会议期间进行测量。是 假设RAAD辅助和阻力治疗将改善踝关节跖屈肌活动 与传统的物理治疗师指导的步态训练相比，第四特定 目的是评估RAAD辅助和阻力下重复步态训练的益处。CP患者 将参加为期4周的援助或阻力干预，并将在术前和术后对移动性结果进行量化。 干预后。据推测，援助和阻力训练将改善流动性的结果。 这一提议为该设备的商业化和实施未来的纵向干预铺平了道路 该研究将调查RAAD改善生活质量和长期临床结局的潜力。