Improving the health status of dysvascular amputees by deploying digital prosthetic interface technology in combination with exercise intervention

通过部署数字假肢接口技术结合运动干预来改善血管障碍性截肢者的健康状况

• 批准号: 10547407
• 负责人: Paolo Bonato
• 金额: $ 105.28万
• 依托单位: BIONIC SKINS LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547407
• 关键词: Adherence; Amputation; Amputees; Area; Bionics; Cardiovascular Diseases; Cardiovascular system; Clinical; Clinical Trials; Data; Data Collection; Diabetes Mellitus; Etiology; Evaluation; Exercise; Finite Element Analysis; Glycemic Index; Goals; Health; Health Status; Image; Individual; Intervention; Knee; Lead; Lesion; Life; Lower Extremity; Maintenance; Measurement; Modeling; Myocardial Infarction; Outcome; Pain; Pain-Free; Patients; Performance; Peripheral Vascular Diseases; Persons; Phase; Physical activity; Prosthesis; Psyche structure; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Recurrence; Rehabilitation therapy; Reporting; Research Project Grants; Risk; Scanning; Secondary to; Skin; Small Business Innovation Research Grant; Stroke; Techniques; Technology; Testing; Time; Tissues; United States; Weight maintenance regimen; X-Ray Computed Tomography; base; biomechanical model; biomechanical test; biophysical model; cohort; computer framework; design; diabetic patient; digital; exercise intervention; exercise program; exercise regimen; experimental study; fitness; improved; intervention program; limb amputation; mortality; novel; patient population; pressure; prosthesis fitting; prosthetic socket; recruit; residual limb; skin irritation; skin ulcer; socket design; soft tissue; synergism; telehealth; tissue injury

Project Summary/Abstract Persons with dysvascular amputations are at great risk for life-threatening cardiovascular disease. While exercise has been shown to reduce this risk, often times dysvascular amputees are unable to perform physical activity due to pressure lesions and sores generated by poor prosthetic socket fit. This Small Business Innovation Research (SBIR) Phase-II project proposes the deployment of a computationally derived transtibial prosthetic interface technology to promote adherence to a tele-health exercise intervention for persons with dysvascular amputation. The prosthetic interface is digitally generated using a computational framework focused on the creation of a liner and socket quantitatively derived from a biophysical model of the amputated residuum. Previously developed at MIT and productized at Bionic Skins, this data-driven design and manufacturing framework is based on a clear scientific rationale to maximize comfort and avoid tissue injury by diminishing areas of high contact pressure between the residuum and interface. The proposed SBIR Phase-II activities are sorted into four specific aims. In Aim 1, subjects with dysvascular transtibial unilateral amputations will be recruited and be separated evenly into two groups. Data on Group 2 will be collected using Computed Tomography (CT) and detailed biomechanical models will be derived from each scan for use in the computational framework. In Aim 2, Finite Element Analysis (FEA) will be combined with test socket evaluations to optimize and then fabricate a definitive liner and socket for all subjects in Group 2 using the Digital Design to Digital Manufacturing pipeline. In Aim 3, initial biomechanical assessments of all socket interfaces (digitally designed and conventional) for both cohorts will be performed using intra-socket interface pressure measurements, thermal imaging measurements of the residuum, a socket evaluation questionnaire, and prosthetist tissue evaluation. In Aim 4 a randomized (superiority) clinical trial will be conducted to compare clinical outcomes over a period of 12 months in dysvascular unilateral transtibial amputees participating in an exercise-based intervention program when using Bionic Skins’ digital prosthetic interface technology vs. a socket that is manufactured using a traditional (artisanal) technique. The assessments outlined in Aim 3 will be performed periodically over the twelve months to gather longitudinal data. Significant differences between the two groups will be reported. The long-term commercial goal of the project is to generate evidence that Bionic Skins’ computationally personalized prosthetic interface is superior to conventional interfaces in comfort, fit, and maintenance of good tissue health and thus a viable option to include in various exercise-related interventions for persons with below-knee amputations, or as an everyday prosthetic interface option.

项目概要/摘要 血管障碍性截肢患者面临着危及生命的心血管疾病的巨大风险。 运动已被证明可以降低这种风险，通常情况下，血管障碍性截肢者无法进行身体活动 由于假肢接受腔贴合不良而产生的压力损伤和溃疡引起的活动。 创新研究（SBIR）二期项目建议部署计算得出的跨胫骨 假肢接口技术可促进患有以下疾病的人坚持远程健康锻炼干预 使用计算框架以数字方式生成血管障碍放大。 专注于根据截肢者的生物物理模型定量地创建衬垫和插座 这种数据驱动的设计和产品先前在 MIT 开发并在 Bionic Skins 生产。 制造框架基于明确的科学原理，通过以下方式最大限度地提高舒适度并避免组织损伤： 残留物和界面之间的高接触压力区域减少。 拟议的 SBIR II 期活动分为四个具体目标：目标 1：患有血管障碍的受试者。 将招募经胫骨单侧截肢者并将其平均分为第 2 组数据的两组。 将使用计算机断层扫描（CT）收集，详细的生物力学模型将来自 在目标 2 中，将结合有限元分析 (FEA) 进行每次扫描。 通过测试插座评估来优化，然后为组中的所有受试者制造最终的衬里和插座 2 使用数字设计到数字制造流程 在目标 3 中，对所有内容进行初始生物力学评估。 两个队列的套接字接口（数字设计和传统）将使用套接字内执行 界面压力测量、残留物热成像测量、插座评估 在目标 4 中，将进行一项随机（优效性）临床试验。 旨在比较单侧经胫骨血管障碍患者 12 个月的临床结果 使用 Bionic Skins 数字假肢参与基于运动的干预计划的截肢者 接口技术与使用传统（手工）技术制造的插座。 目标 3 中概述的评估将在 12 个月内定期进行，以收集纵向数据 将报告两组之间的显着差异。 该项目的长期商业目标是提供证据，证明仿生皮肤的计算能力 个性化假肢接口在舒适性、贴合性和维护性方面优于传统接口 组织健康，因此是纳入各种与运动相关的干预措施的可行选择 膝下截肢，或作为日常假肢接口选项。