Assistive ExoSkeleton and ExoTendon System for Increased Return of Limb Function after Diabetic Foot Ulcer

项目摘要/摘要 与使命的关联性：应用程序与2019年NINR和NIA的补充目标保持一致： NINR：Assitive…可以…的设备提高慢性病患者的生活质量 NIA：开发技术/机器人，以帮助改善身体功能和机动性 在(康复前)或(康复)择期/计划手术之前或之后的老年人 医疗需求：此应用程序侧重于糖尿病足溃疡(DFU)的二级预防，当患者 是最脆弱的。DFU是截肢的主要原因，比最昂贵的癌症更昂贵，而且 截肢的幸存者的死亡率比排名前十的癌症中的一半更高。 发明：与患者的输入一起，团队设计了一种新型的辅助外骨骼，该外骨骼已经展示 在PhI中，我研究通过部署一种颠覆性的康复机器人设计来减轻脚上的压力。它 集成结构外骨骼以将肢体外力外化到身体外部。在两个第一阶段的研究中， 外骨骼已经显示出前脚下力量的减少。出乎意料的是，这款设备还 在降低步幅的同时增加步长和步行速度，显示出推进能力的改善 足底压力。该设备从多名参与者那里收到了热情的患者反馈 他们乐于感受“脚步中的春天”，也没有表现出对跌倒风险衡量的负面影响。 目标1)产品改进工程：团队将改进Ph I原型以克服以下问题 舒适，并确保耐用性和坚固性。 目标2)步态的运动恢复&平衡、活动、心理-社会：原型将被评估 在创面完成后1、3和6个月帮助恢复临床步态功能和平衡的能力 DFU治疗后的愈合情况及其对恢复日常体力活动水平的影响 和心理社会措施。疗效(复发率)超出SBIR的可用预算，并将 通过大学主导的合作研究进行研究。 基本原理：该团队最近通过NIH/美国国立卫生研究院完成了两项由SBIR资助的第一阶段研究 护理研究和前交叉韧带/国家残疾、独立生活和康复研究所。 结果表明，样机能够通过外力来卸载显著的压力。团队有 获得4项美国专利和国际知识产权。如果成功，这将是第一次颠覆性的 几十年来卸载方面的创新，并阐明了未来评估机器人卸载的关键设计因素 加载装置和传感器控制装置。

Project Summary / Abstract Relatedness to Mission: Application aligns with 2019 Supplemental Goals for both NINR & NIA.: NINR: Assistive…devices that can… improve quality of life for individuals with chronic diseases/conditions NIA: Development of technologies/robotics to assist in the improvement of physical function and mobility in older persons prior to (pre-habilitation) or following (rehabilitation) elective/planned surgery Medical need: This application focuses on secondary prevention of diabetic foot ulcer (DFU) when patients are most vulnerable. DFU is the leading cause of amputation, more costly than the most expensive cancer, and survivors of lower limb amputation have a higher mortality rate than half of the top 10 cancers. Invention: Together with patient input, team has designed a novel assistive exoskeleton that has been shown in Ph I studies to off-load pressure from the foot by deploying a disruptive design for rehabilitation robotics. It integrates a structural exo-skeleton to externalize lower limb forces outside of the body. In two Phase I studies, the exoskeleton has demonstrated reduction of force under the forefoot. Unexpectedly, the device has also demonstrated improved propulsion by increasing stride length and walking speed concurrent to reducing plantar pressures. The device has received enthusiastic patient feedback from multiple participants who enjoyed feeling a “spring in their step” and showed no negative impact on measures of fall risk. Aim 1) Product Refinement Engineering: Team will improve upon Ph I prototypes to overcome issues with comfort and to ensure durability and robustness. Aim 2) Motor Restoration of Gait & Balance, Activity, Psycho-Social: The prototypes will be evaluated for their ability to help restore clinical gait function and balance at 1, 3 and 6 months after completion of wound healing subsequent to DFU treatment as well as their impact on the restoration of daily physical activity level and psycho social measures. Efficacy (recurrence rates) are beyond the available budget of SBIR and will be pursued with collaborative university led research. Rationale: The team recently completed two Phase I SBIR funded studies through NIH/National Institute of Nursing Research and ACL/National Institute for Disability, Independent Living and Rehabilitation Research. Results show that the prototypes were able to off-load significant pressure by externalizing forces. Team has been awarded 4 issued US patents and international IP. If successful, this will be the first disruptive innovation in off-loading in decades and illuminates key design factors for future evaluation of robotic off- loading devices and sensor controlled devices.