NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait

NewGait：一种改善中风后步态的低成本康复系统

• 批准号: 10611686
• 负责人: CHANDRAMOULI KRISHNAN
• 金额: $ 34.48万
• 依托单位: ELITE ATHLETE PRODUCTS INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10611686
• 关键词: Address; Adoption; Adult; Affect; Biomechanics; Caregivers; Caring; Clinic; Clinical; Communities; Computer software; Cross-Over Studies; Data; Developing Countries; Devices; Economically Deprived Population; Effectiveness; Equilibrium; Exhibits; Fatigue; Feasibility Studies; Feedback; Foundations; Gait; Gait speed; Goals; Grant; Home; Impairment; Individual; Intervention; Joints; Legal patent; Length; Long-Term Effects; Lower Extremity; Mechanics; Medical; Michigan; Modeling; Modification; Muscle; Musculoskeletal; Nervous system structure; Neuronal Plasticity; Outcome; Participant; Patients; Periodicity; Phase; Physical therapy; Population; Power Sources; Randomized; Randomized Controlled Trials; Rehabilitation device; Rehabilitation therapy; Resources; Rural Community; Rural Population; Series; Small Business Technology Transfer Research; Specialist; Sports; Stroke; System; Techniques; Testing; Therapeutic; Traction; Training; United States; Universities; Walking; base; biomechanical model; biomechanical test; chronic stroke; comparative; cost; design; disability; disadvantaged population; dosage; evidence base; exosuit; experience; gait rehabilitation; human centered design; improved; innovation; insight; light weight; mechanical behavior; mobility rehabilitation; neurological rehabilitation; neurophysiology; novel therapeutic intervention; physical therapist; portability; post stroke; preference; prototype; restoration; robotic device; satisfaction; stroke rehabilitation; stroke survivor; treadmill; usability; walking speed; wearable sensor technology

PROJECT SUMMARY More than 795,000 individuals suffer from a stroke each year in the United States, making stroke a leading cause of adult disability in the United States and worldwide. More than half of stroke survivors exhibit reduced independence and functional mobility due to stroke-related gait impairments. Despite significant advancements in post-stroke medical care and rehabilitation, current treatments are not successful in optimally restoring gait function after stroke. It is well established that intense, repetitive task-oriented rehabilitation interventions are essential for inducing experience-dependent neuroplasticity (defined as the ability of the nervous system to adapt and optimize its resources through structural and functional changes)—which is a key factor for post-stroke gait recovery. Accordingly, new therapeutic approaches that rely on specialized gait training devices, such as treadmills, robotic devices, and exosuits have been developed. However, these devices are typically expensive, bulky, and not accessible for home use. Moreover, these devices often require uninterrupted power sources, which is a major barrier for rural communities in developing nations. While some lightweight and “low-cost” commercial devices exist, they are not often designed based on multi-user feedback and robust biomechanical data and their clinical utility have not been tested in stroke survivors, thereby limiting usability and effectiveness. Thus, there is a significant unmet clinical need for an effective, affordable, and portable gait mobility/rehabilitation device that is accessible for most stroke survivors. Elite Athlete Products (EAP) has designed a wearable gait rehabilitation system, NewGait, that specifically addresses this clinical need. In this Phase-I STTR, EAP has assembled an interdisciplinary team to pursue the following specific aims: (1) Identify an optimal NewGait design based on end-user feedback (design sprints) and musculoskeletal modeling to address the needs of stroke rehabilitation, (2) Refine the current prototype using data gathered from design sprints and think aloud technique and perform benchtop testing on the final prototype to validate durability, and (3) Examine short-term gait adaptations and clinical feasibility in stroke survivors by performing a comparative clinical feasibility study in stroke survivors to establish the clinical utility of the NewGait device in comparison with two competitive devices (TheraSuit and TheraTogs). This project combines EAP’s expertise in developing low-cost neurorehabilitation devices with the clinical, biomechanical, and neuroplasticity expertise of our academic partners at the University of Michigan and Wayne State University. The successful completion of this Phase-I STTR will lay the foundation for an evidence-based low-cost gait rehabilitation system that could positively affect the lives of millions of stroke survivors living across the globe.

项目摘要 在美国，每年有超过795，000人患有中风，使中风成为主要原因 在美国和全世界的成年残疾人中。超过一半的中风幸存者表现出减少 独立性和功能性活动性，由于中风相关的步态障碍。尽管取得了重大进步 在中风后医疗护理和康复中，目前的治疗不能成功地最佳地恢复步态 中风后的功能众所周知，密集的、重复的任务导向的康复干预是 对于诱导经验依赖性神经可塑性（定义为神经系统适应的能力）至关重要 并通过结构和功能变化优化其资源）-这是中风后步态的关键因素 复苏因此，依赖于专门的步态训练装置的新的治疗方法， 已经开发出了机器人、机器人设备和机器护甲。然而，这些装置通常是昂贵的， 体积大，并且不能用于家庭使用。此外，这些设备通常需要不间断的电源， 这是发展中国家农村社区的主要障碍。虽然一些轻量级和“低成本” 商业设备存在，它们通常不是基于多用户反馈和鲁棒的生物力学设计的。 数据及其临床效用尚未在中风幸存者中进行测试，从而限制了可用性和有效性。 因此，对于有效的、可负担的和便携的步态移动性/康复，存在显著的未满足的临床需求 大多数中风幸存者都可以使用的设备。精英运动员产品（EAP）设计了一种可穿戴步态 康复系统，新步态，专门解决这一临床需求。在本第一阶段STTR中，EAP已 我组建了一个跨学科的团队，以追求以下具体目标：（1）确定最佳的NewGait设计 基于最终用户反馈（设计冲刺）和肌肉骨骼建模，以满足中风的需求 康复，（2）使用从设计冲刺和大声思考技术收集的数据来完善当前原型 并对最终原型进行台架测试，以验证耐久性，以及（3）检查短期步态 适应性和临床可行性，通过进行比较临床可行性研究， 卒中幸存者，以确定NewGait器械与两种竞争器械相比的临床效用 （TheraSuit和TheraTogs）。该项目结合了EAP在开发低成本神经康复方面的专业知识 设备与我们的学术合作伙伴在大学的临床，生物力学和神经可塑性的专业知识 密歇根大学和韦恩州立大学。第一阶段短期试验计划的顺利完成，将为 以证据为基础的低成本步态康复系统，可以积极影响数百万中风患者的生活， 生活在地球仪各地的幸存者。