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: 10707261
• 负责人: Paolo Bonato
• 金额: $ 90.69万
• 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/10707261
• 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; Recurrence; Rehabilitation therapy; Reporting; Research Project Grants; Risk; Scanning; Secondary to; Skin; Small Business Innovation Research Grant; Sorting; Stroke; Techniques; Technology; Testing; Tissues; United States; Weight maintenance regimen; X-Ray Computed Tomography; biomechanical model; biomechanical test; biophysical model; cohort; computer framework; design; diabetic patient; digital; exercise intervention; exercise program; exercise regimen; experimental study; fabrication; fitness; improved; intervention program; limb amputation; manufacture; mortality; novel; patient population; pressure; prosthesis fitting; prosthetic socket; randomized, clinical trials; 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 血管截肢的人有威胁生命的心血管疾病的危险。尽管 运动已被证明可以降低这种风险，通常有时血管症状截肢者无法进行身体 由于假体插座拟合不良而产生的压力病变和疮的活性。这个小型企业 创新研究（SBIR）II期项目提出了计算得出的可交易率的部署 假肢界面技术，以促进对有远程医疗运动干预的依从性 血管截肢。假体接口是使用计算框架以数字化生成的 专注于从截肢的生物物理模型定量得出的衬里和插座 残留物。以前在麻省理工学院开发并在仿生皮肤上生产，该数据驱动设计和 制造框架是基于明确的科学原理，以最大程度地提高舒适感并避免通过 残留物和界面之间高接触压力的区域减小。 提出的SBIR II期活动被分为四个特定目标。在AIM 1中，血管血管的受试者 将招募单方面截肢，并将其均匀分为两组。第2组的数据 将使用计算机断层扫描（CT）收集，详细的生物力学模型将从 每次扫描用于计算框架。在AIM 2中，将组合有限元分析（FEA） 使用测试套接字评估以优化，然后为组中的所有受试者制造确定的衬里和套接字 2使用数字设计用于数字制造管道。在AIM 3中，所有人的初步生物力学评估 将使用插槽内进行两个队列的插座接口（数字设计和常规） 界面压力测量，残留物的热成像测量，插座评估 问卷和假肢组织评估。在AIM 4中，随机（优势）临床试验将是 进行了12个月的临床结局，以比较血管症的单侧三个月的临床结果 使用仿生皮肤的数字假肢时，截肢者参加了基于运动的干预计划 界面技术与使用传统（手工）技术制造的插座。这 AIM 3中概述的评估将在十二个月内定期进行，以收集纵向 数据。两组之间将有显着差异。 该项目的长期商业目标是产生证据表明仿生皮肤的计算 个性化的假肢界面优于舒适，适合和维护良好的传统界面 组织健康，因此是一个可行的选择，可以在各种与运动有关的干预措施中 膝盖截肢或每天的假肢接口选项。