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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.

项目摘要/摘要儿童从事体育活动的能力对他们的健康、独立和总体幸福至关重要。美国50万儿童中的许多人患有脑瘫(CP)，这是儿科疾病最常见的原因身体残疾，行走和参与体力活动有困难。这减少了体力活动 CP是代谢功能障碍、心血管疾病、骨质疏松症、疼痛和生活心理社会质量下降。不幸的是，有一半的流动儿童患有 CP在成年后失去独立行走的能力，表明目前治疗这些疾病的方法随着时间的推移，个人并不会带来有意义的移动性改善。物理治疗(PT)对于治疗慢性支气管炎，但PT的量通常不足，PT的输送可能效率低下。的确有目前没有可行的方法来提供足够剂量的PT，从而长期改善机动性和减少上述负面的物质和社会后果。BiOMOTUM(申请人)的目标是创建一个为患有脑瘫的儿童提供可报销的可穿戴系统，将(1)使行走更轻松，并改善自由生活活动度，(2)增加脚踝足底屈肌疗法的剂量和精确度，以产生持久的改善神经肌肉功能，以及(3)创建虚拟社区以激励系统和跟踪的使用进步。为了实现这些目标，该项目使用了轻便、低调、电池供电、可穿戴的机器人踝关节辅助装置(RAAD)。这项建议的总体目标是确定 RAAD系统，以改善自由生活环境中的流动性，并将RAAD确立为有效的工具，以提供增加了靶向脚踝治疗的剂量和精确度。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与不使用RAAD设备相比，使用RAAD设备可以在社区中走得更远。第二个具体问题目的是收集反馈，以设计和原型最低限度可行的产品，用于临床和社区设置。第三个具体目标是量化RAAD系统提高以下方面效力的潜力临床步态疗法。患有CP的个人将完成三个培训课程：RAAD援助、RAAD 抵抗力和护理标准。肌肉活动和步态活动将在每次训练中进行测量。它是假设RAAD辅助和抵抗疗法将改善脚踝足底屈肌活动与传统的物理治疗师指导的步态训练相比，治疗会话质量更高。第四个具体问题目的是评估重复步态训练在RAAD辅助和抵抗下的益处。慢性支气管炎患者将参加为期4周的援助或抵抗干预，活动结果将在干预后。据推测，援助和抵抗训练都将改善流动性结果。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这将调查RAAD改善生活质量和长期临床结果的潜力。