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

辅助外骨骼和外肌腱系统可增强糖尿病足溃疡后肢体功能的恢复

基本信息

批准号：
10406377
负责人：
Mark C Roser
金额：
$ 81.91万
依托单位：
RESULTS GROUP
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：
2021-05-17 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10406377
关键词：
3D Print Adherence Aftercare Amputation Anxiety Area Award Back Blood Budgets Cancer Survivor Caring Cellular Phone Chronic Disease Clinical Clinical effectiveness Control Groups Data Devices Diabetes Mellitus Diabetic Foot Ulcer Ecological momentary assessment Effectiveness Elderly Engineering Ensure Equilibrium Evaluation Fatigue Feedback Feeling Floor Foot Ulcer Fostering Frequencies Funding Future Gait Gait speed Goals Habilitation Healthcare Systems Home Hour Independent Living Individual Institutes Instruction International Learning Leg Legal patent Length Limb structure Lower Extremity Lung Malignant Neoplasms Malignant neoplasm of lung Measures Medical Mental Depression Mission Motor National Institute of Nursing Research Operative Surgical Procedures Participant Patients Persons Phase Physical Function Physical activity Prevalence Prevention Production Property Quality of life Randomized Controlled Trials Recurrence Rehabilitation therapy Research Risk Robotics Scanning Secondary Prevention Self-Help Devices Shelter facility Shoes Small Business Innovation Research Grant Spottings System Tendon structure Testing Time Ulcer United States National Institutes of Health Universities Walking Work achilles tendon ankle joint base clinically significant cost design diabetic disability exoskeleton experience fall risk follow-up foot group intervention healing high risk improved innovation invention light weight limb amputation member mortality mortality risk multidisciplinary novel phase 1 study phase 1 testing phase I trial pressure primary outcome prototype psychosocial rehabilitation research research clinical testing restoration robot rehabilitation secondary outcome sensor skin irritation social social metrics standard of care technology development walking speed wound closure wound healing

项目摘要

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.

项目概要/摘要与使命的相关性：申请符合 NINR 和 NIA 的 2019 年补充目标： NINR：辅助……设备可以……改善慢性病/病症患者的生活质量 NIA：开发技术/机器人以协助改善身体功能和活动能力择期/计划手术之前（康复前）或之后（康复）的老年人医疗需求：该应用程序侧重于糖尿病足溃疡（DFU）患者的二级预防 DFU 是截肢的主要原因，其费用比最昂贵的癌症还要高。下肢截肢幸存者的死亡率比十大癌症中的一半还要高。发明：结合患者的意见，团队设计了一种新型辅助外骨骼，并已展示在第一阶段研究中，通过部署康复机器人的颠覆性设计来减轻足部压力。在两项一期研究中，整合了结构性外骨骼，将下肢力量外化到体外。出乎意料的是，外骨骼还减少了前脚的受力。通过增加步幅来提高推进力，并在减少步行速度的同时证明步行速度该设备已收到多位患者的热情反馈。享受“脚步轻快”的感觉，并且对跌倒风险的衡量指标没有产生负面影响。目标 1) 产品细化工程：团队将改进第一阶段原型，以克服以下问题舒适度并确保耐用性和坚固性。目标 2) 步态和平衡、活动、心理社会的运动恢复：将对原型进行评估他们在伤口完成后 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的效果（复发率）超出了 SBIR 的可用预算，并将与合作大学主导的研究一起进行。理由：该团队最近通过 NIH/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 ACL/国家残疾、独立生活和康复研究所。结果表明，原型能够通过外部化力量来减轻巨大的压力。已获得 4 项美国专利和国际知识产权如果成功，这将是第一个颠覆性的。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。