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。

基本信息

批准号：
10472074
负责人：
RAYMOND Clifton BROWNING
金额：
$ 77.24万
依托单位：
BIOMOTUM, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10472074
关键词：
Activities of Daily Living Adult Ankle Cardiovascular Diseases Cerebral Palsy Child Childhood Clinical Clinical Trials Clinical effectiveness Communities Data Development Devices Dose Effectiveness Family Feedback Financial Hardship Flexor Foundations Functional disorder Funding Future Gait Gait abnormality Goals Health Home Impairment Incentives Incidence Individual Intervention Interview Manufacturer Name Measures Mechanics Medical Device Metabolic dysfunction Modality Movement Disorders Muscle Muscle function Osteoporosis Outcome Pain Parents Personal Satisfaction Persons Phase Physical activity Physical therapy Quality of life Reporting Research Resistance Robotics Safety School-Age Population Self-Help Devices Social outcome Stress System Technology Testing Time Training Travel United States United States National Institutes of Health Validation Walking clinical efficacy community setting cost cost effective design engineering design gait rehabilitation improved improved mobility light weight mobility aid neuromuscular neuromuscular function online community peer physical therapist physically handicapped post intervention prototype psychosocial recruit robot exoskeleton standard of care strength training tool wearable sensor technology

项目摘要

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.

项目概要/摘要孩子参与体育活动的能力对于他们的健康、独立性和整体福祉至关重要。美国 50 万儿童中有许多患有脑瘫 (CP)，脑瘫是儿科最常见的病因身体残疾，行走和参加体力活动有困难，这减少了体力活动。 CP 是导致代谢功能障碍、心血管疾病、不幸的是，一半的流动儿童患有骨质疏松症、疼痛和社会心理生活质量下降。 CP 在成年后失去独立行走的能力，表明目前治疗这些的方法随着时间的推移，个人不会显着改善活动能力。治疗 CP，但 PT 的量通常不足，且 PT 的输送效率较低。目前没有可行的方法来提供足够剂量的 PT 来长期改善活动能力和 BiOMOTUM（申请人）的目标是减少上述负面的身体和社会后果。为脑瘫儿童提供可报销的可穿戴系统，该系统将 (1) 让行走变得更轻松并改善自由生活活动能力，(2) 增加踝关节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，以及（3）创建一个虚拟社区来激励系统的使用并跟踪为了实现这些目标，该项目采用了轻质、低调、电池供电的可穿戴设备。该提案的总体目标是确定机器人踝关节辅助装置（RAAD）的可行性。 RAAD 系统旨在改善自由生活环境中的流动性，并将 RAAD 建立为提供增加剂量和精确度的靶向踝关节治疗的第一个具体目标是完成个人使用。开发脚踝活动辅助装置的可行性分析，孩子们将能够安全地走得更快。与不使用 RAAD 设备相比，使用 RAAD 设备可以在社区中走得更远。目的是收集反馈，设计和制作用于临床和社区的最小可行产品原型第三个具体目标是量化 RAAD 系统提高有效性的潜力。临床步态治疗脑瘫患者将完成三个培训课程：RAAD 辅助、RAAD 每次训练期间都会测量肌肉活动和步数活动。准备好 RAAD 辅助和阻力疗法将改善踝关节跖屈肌活动与传统物理治疗师指导的步态训练相比，治疗过程的质量和质量。目的是评估在 RAAD 辅助和阻力下进行重复步态训练的益处。将参加为期 4 周的援助或抵抗干预，并且行动结果将在行动前和行动前进行量化干预后，加强援助和阻力训练将改善行动能力。该提案为该设备的商业化和实施未来的纵向干预措施铺平了道路这将调查 RAAD 改善生活质量和长期临床结果的潜力。