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.

项目摘要/摘要 血管功能障碍截肢者患危及生命的心血管疾病的风险很大。而当 运动已被证明可以降低这种风险，血管障碍截肢者往往无法进行身体锻炼。 活动因受压损伤和假体插座适合性差而产生的溃疡。这家小型企业 创新研究(SBIR)第二阶段项目建议部署一个计算衍生的经胫骨 假体接口技术，以促进符合远程健康运动干预的患者 血管障碍性截肢。使用计算框架以数字方式生成假体界面 重点介绍了从截肢者的生物物理模型中定量推导出的衬垫和插座 残渣。之前在麻省理工学院开发并在仿生皮肤公司生产，这种数据驱动的设计和 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性并避免组织损伤 残渣与界面之间的高接触压力区逐渐减小。 拟议的SBIR第二阶段活动分为四个具体目标。在目标1中，患有血管障碍的受试者 将招募经胫骨一侧截肢，并将其平均分成两组。关于组2的数据 将使用计算机断层扫描(CT)收集，详细的生物力学模型将从 每一次扫描都用于计算框架。在目标2中，将结合有限元分析(FEA 通过测试插座评估优化，然后为小组中的所有受试者制造最终的衬垫和插座 2利用数字化设计到数字化制造的管道。在目标3中，所有患者的初步生物力学评估 这两组人的套接字接口(数字设计的和传统的)将使用套接字内 界面压力测量，残留物热成像测量，插座评估 问卷调查和假体组织评价。在目标4中，将进行随机(优势)临床试验 对单侧胫骨血管障碍患者12个月的临床结果进行比较 截肢者在使用仿生皮肤数字假体时参加基于运动的干预计划 接口技术与使用传统(手工)技术制造的插座。这个 目标3中概述的评估将在12个月内定期执行，以纵向收集 数据。两组之间的显著差异将被报告。 该项目的长期商业目标是产生证据，证明仿生皮肤在计算上 个性化假体界面在舒适性、适合性和良好的维护性方面优于传统界面 组织健康，因此是一种可行的选择，以包括在各种运动相关的干预措施的人 膝盖以下截肢，或作为日常假肢接口选项。