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，发病率和死亡率据估计，多达三分之一的糖尿病患者会患上糖尿病足。一生中患溃疡 (DFU) 不愈合的 DFU 是导致住院、截肢、残疾和残疾的主要原因。在美国，糖尿病相关费用的三分之一都花在了糖尿病患者的死亡上。糖尿病足部护理，其中三分之二的费用发生在住院环境中，构成了巨大的经济损失因此，应采取一切可能的手段来治愈 DFU 并防止截肢。在这方面，有大量证据表明运动对患有以下疾病的人有临床益处： DFU，包括改善血流和氧气供应、预防肌肉损失和关节活动度。证据表明，运动并不是伤口愈合标准护理的一部分，主要是因为没有促进伤口愈合的解决方案为 DFU 患者管理家庭锻炼计划。在这个第一期 SBIR 项目中，我们将为 DFU 患者设计交互式足踝锻炼计划使用名为 Tele-FootX™ 的可穿戴传感器将实现远程和虚拟监督。基于证据的足部和脚踝锻炼，可以教育、监测和指导患者。该平台的游戏功能将促进遵守规定的锻炼计划，随后，这种方法得到了我们的概念验证研究的支持，我们证明了这种方法的好处。交互式足部和踝关节练习，以改善下肢灌注并增加小腿的活动为了实现这一目标，在目标 1 中，我们将使用足部设计一个基于互动游戏的锻炼平台。安装了传感器，并通过包含受 DFU 启发的基于游戏的练习，使其适合 DFU 患者在目标 2 中，我们将论证 Buerger-Allen 练习计划的可接受性、可行性、安全性和证明。通过招募 15 名参与者，了解 Tele-FootX 在改善下肢灌注方面的概念有效性 DFU。我们将检查感知的好处、易用性、技术接受度、可用性和技术。从目标 2 中招募的 15 名 DFU 参与者以及 10 名医疗保健人员的角度来看，他们的焦虑程度具有 DFU 管理专业知识的专业人员。在第二阶段，我们将推出新的游戏功能以提高参与度，以及供顾客使用的功能我们还将为每位患者提供教育、管理和个性化的家庭锻炼计划。将提议的解决方案纳入现有医院记录和远程评估（例如，EPIC）。我们将验证最终结果。现有的 CPT 代码涵盖了远程锻炼计划。报销代码（CPT 代码 98975、98977、98980 和 98981）的存在、大尺寸市场（全球每年有 2610 万人开发 DUF），以及拟议的显着临床效益解决方案将促进 Tele-FootX 的商业化。