Tele-FootX: Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

Tele-FootX：用于加速足底伤口愈合的虚拟监督远程锻炼平台

基本信息

批准号：
10701324
负责人：
Bijan Najafi
金额：
$ 27.5万
依托单位：
BIOSENSICS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-15 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10701324
关键词：
Acceleration Achievement Address Adherence Amputation Ankle Anxiety Architecture Area Award Blood capillaries Blood flow Caregivers Caring Cessation of life Clinical Code Collaborations Complications of Diabetes Mellitus Current Procedural Terminology Codes Data Security Dementia Development Diabetes Mellitus Diabetic Foot Diabetic Foot Ulcer Direct Costs Economic Burden Effectiveness Exercise Foot Diseases Foot Ulcer Generations Goals Health Professional Home Hospital Records Hospitalization Hour Inpatients Intervention Lower Extremity Malignant Neoplasms Marketing Measures Medicine Modeling Monitor Morbidity - disease rate Muscle Muscular Atrophy Near-Infrared Spectroscopy Notification Oxygen Participant Pathway interactions Patients Performance Perfusion Persons Phase Prevention Progress Reports Questionnaires Randomized, Controlled Trials Rest Risk Factors Safety Sampling Secure Series Small Business Innovation Research Grant Societies System Technology Telemedicine United States United States National Institutes of Health Visualization Work college commercialization cost dashboard data access data integration deconditioning design digital disability evidence base exercise prescription exercise program exergame experience feasibility trial foot healing improved joint mobilization mortality older patient participant interview phase 1 study pressure prevent programs prototype recruit remote assessment safety and feasibility sensor spectroscopic imaging standard care standard of care success tele-exercise tissue oxygenation tool uptake usability video chat virtual virtual coach wearable sensor technology web app web services wound care wound healing wound treatment

项目摘要

Abstract Foot ulceration is the most common and costly late complication of diabetes, with morbidity and mortality being worse than many cancers. It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer (DFU) in their lifetime. Non-healing DFUs are a leading cause of hospitalization, amputation, disability, and death among people with diabetes. In the United States, one-third of all diabetes-related costs are spent on diabetic foot care, with two-thirds of the costs incurred in inpatient settings, constituting a substantial economic burden to society. Therefore, every means possible should be used to try to heal DFU and prevent amputation. In this regard, there is a significant body of evidence related to the clinical benefits of exercise for people with DFU, including improving blood flow and oxygen supply, muscle loss prevention, and joint mobility. Despite this evidence, exercise is not part of the standard care for wound healing, mainly as there is no solution for promoting and managing home-based exercise programs for people with DFU. In this Phase I SBIR project, we will design an interactive foot and ankle exercise program for people with DFU using wearable sensors called Tele-FootX™. Tele-FootX will enable both remotely and virtually supervised evidence-based foot and ankle exercises and allow clinicians to educate, monitor, and coach patients. The gaming features of the platform will promote adherence to the prescribed exercise programs, and, subsequently, wound healing. This approach is supported by our proof-of-concept study, where we demonstrated the benefit of interactive foot and ankle exercises to improve lower extremity perfusion and increase activity in the calf muscle. To achieve this goal, in Aim 1, we will design an interactive game-based exercise platform using foot- mounted sensors and make it suitable for people with DFU by including game-based exercises inspired by the Buerger-Allen exercise program. In Aim 2, we will demonstrate the acceptability, feasibility, safety, and proof of concept effectiveness of the Tele-FootX in improving lower extremity perfusion by recruiting 15 participants with DFU. We will examine the perceived benefit, ease of use, technology acceptance, usability, and technology anxiety from the point of view of the 15 participants with DFU recruited in Aim 2, as well as 10 health care professionals with expertise in DFU management. In Phase II, we will introduce new gaming features to improve engagement, as well as features for clinicians to educate, manage and personalize the home-based exercise program for each patient. We will also integrate the proposed solution into existing hospital records and remote assessments (e.g., EPIC). We will validate the final product in a 12-week randomized control trial. There are existing CPT codes that cover tele-exercise programs. The existence of reimbursement codes (CPT codes 98975, 98977, 98980, and 98981), the large size of the market (26.1 million worldwide develop DUF annually), and the significant clinical benefits of the proposed solution will facilitate commercialization of Tele-FootX.

抽象的足部溃疡是糖尿病最常见，最昂贵的晚期并发症，发病率和死亡率是比许多癌症还糟。据估计，多达三分之一的糖尿病患者会发展糖尿病脚溃疡（DFU）一生。非治疗DFU是住院，截肢，残疾和糖尿病患者的死亡。在美国，所有与糖尿病有关的费用的三分之一用于糖尿病足护理，住院环境中产生的成本的三分之二，构成了实质性的经济负担社会。因此，应使用每种方法来尝试治愈DFU并防止截肢。在这方面，有大量证据与运动的临床益处有关 DFU，包括改善血流和氧气供应，预防肌肉损失和关节迁移率。尽管如此证据，运动不是伤口愈合的标准护理的一部分，主要是因为没有解决方案并为DFU患者管理基于家庭的锻炼计划。在这个I阶段I SBIR项目中，我们将为DFU患者设计一个互动脚和脚踝锻炼计划使用称为Tele-Footx™的可穿戴传感器。 Tele-Footx将启用远程和虚拟监督基于证据的脚和踝关节锻炼，允许临床医生对患者进行教育，监测和教练。平台的游戏功能将促进遵守规定的锻炼计划，然后，随后，伤口愈合。我们的概念证明研究支持了这种方法，我们证明了好处互动脚和脚踝锻炼以改善下肢灌注并增加小牛的活动肌肉。为了实现这一目标，在AIM 1中，我们将使用Foot-设计一个基于互动游戏的运动平台安装传感器，使其适合于DFU的人，包括受游戏启发的基于游戏的练习 Buerger-Allen锻炼计划。在AIM 2中，我们将证明可接受性，可行性，安全性和证明通过招募15名参与者 DFU。我们将研究感知到的收益，易用性，技术接受，可用性和技术从AIM 2中招募的15名参与者的观点以及10个医疗保健的焦虑具有DFU管理专业知识的专业人士。在第二阶段，我们将介绍新的游戏功能以改善参与度，以及临床医生的功能为每个患者教育，管理和个性化家庭锻炼计划。我们还将整合提出了对现有医院记录和远程评估的解决方案（例如Epic）。我们将验证决赛在12周的随机对照试验中产物。现有的CPT代码涵盖了远程运动计划。报销代码的存在（CPT代码98975、98977、98980和98981），市场（全球每年开发2610万个DUF），以及拟议中的重大临床益处解决方案将促进远程触发的商业化。