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/摘要孩子从事体育锻炼的能力对于他们的健康，独立性和一般福祉至关重要。在美国的50万个儿童中，有许多脑瘫（CP），这是小儿最常见的原因身体残疾，步行困难并参加体育锻炼。这减少了体育锻炼 CP是代谢功能障碍，心血管疾病，心血管疾病的更大事件的主要因素骨质疏松症，疼痛和心理社会生活质量降低。不幸的是，在所有门诊儿童中有一半患有 CP失去了成年后独立行走的能力，表明当前的治疗方法个人不会随着时间的流逝而有意义地提高流动性。物理疗法（PT）对于治疗CP，但PT的量通常不足，PT的递送效率可能降低。有目前尚无可行的方法来提供足够的PT，这将导致移动性的长期改善和减少上面指出的负面身体和社会结果。 biomotum的（申请人）目标是创建一个可为患有CP儿童的可穿戴系统可偿还可穿戴系统，该系统将（1）使行走更轻松并改善自由生活移动性，（2）提高脚踝底线疗法的剂量和精度，以产生持久的改善神经肌肉功能，（3）创建一个虚拟社区，以激励系统的使用并跟踪改进。为了实现这些目标，该项目使用轻巧，低调，电池供电，可穿戴机器人脚踝辅助装置（RAAD）。该提案的总体目标是确定 RAAD系统以改善自由生活环境中的移动性，并确定RAAD作为提供的有效工具靶向踝部疗法的剂量和精度增加。第一个具体目的是完成个人使用踝关节活动援助的可行性分析。假设孩子们将能够安全行走更快当使用RAAD设备与没有设备的情况下，在社区中旅行。第二个特定目的是收集反馈，以设计和原型为临床和社区中使用的最低可行产品设置。第三个具体目的是量化RAAD系统提高有效性的潜力临床GIT疗法。 CP的个人将完成三个培训课程：RAAD援助，RAAD 阻力和护理标准。每次会议期间将测量肌肉活动和步骤活动。这是假设RAAD辅助和抵抗治疗将改善脚踝肌肉活动与传统的物理治疗师指导的聚集培训相比，治疗课程的质量。第四个特定目的是通过RAAD援助和抵抗来评估重复聚集培训的好处。患有CP的人将参加为期4周的援助或抵抗干预措施，并将量化流动性结果干预后。假设援助和抵抗训练都可以改善移动性结果。该建议为设备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。