Development of advanced personalized modular pressure relief seating cushion systems: Testing and user evaluation

先进个性化模块化减压座垫系统的开发：测试和用户评估

• 批准号: 10631894
• 负责人: KATH BOGIE
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10631894
• 关键词: 3D Print; Activities of Daily Living; Advanced Development; Algorithms; Area; Benchmarking; Caring; Charge; Clinic; Clinical; Clinical Research; Clinical assessments; Cost Analysis; Custom; Data; Development; Disinfection; Elderly; Engineering; Enrollment; Ensure; Evaluation; Foundations; Frequencies; Gel; Generations; Goals; Health; Health Status; Health care facility; Humidity; Individual; Inpatients; Life; Long-Term Care; Manual wheelchair; Maps; Mattresses; Measures; Mechanics; Medical center; Monitor; Nursing Research; Ohio; Participant; Pelvis; Performance; Permeability; Persons; Pilot Projects; Positioning Attribute; Posture; Powered wheelchair; Price; Process; Property; Protocols documentation; Questionnaires; Randomized; Recovery; Research Design; Risk; Scheme; Self-Help Devices; Silicon; Silicones; Skin; Spinal cord injury; Support System; Surface; System; Technology; Telephone; Temperature; Testing; Time; Tissues; Translations; United States Department of Veterans Affairs; Veterans; Weight; Wheelchairs; Willow; Wood material; Work; base; commercialization; cost; cost effective; daily functioning; decubitus ulcer; design; innovation; instrument; mechanical properties; next generation; novel; pre-clinical; preclinical development; pressure; prevent; programs; prototype; repaired; replicator; research study; response; satisfaction; sensor; wound

Pressure injuries are a significant secondary complications for many individuals with reduced mobility, including elderly Veterans and those with spinal cord injury (SCI). Core assistive technology for persons with limited mobility includes a wheelchair seating system, comprising both a wheelchair and an effective pressure relief cushion. All wheelchair users are at some increased risk of pelvic region pressure injuries while sitting. Numerous studies have shown that although no one cushion can meet every user's needs, pressure relieving cushions are a critical component in all wheelchair seating systems to maximize function for individuals with mobility restrictions and decrease the risk of pressure injury development. An effective cushion prevents tissue breakdown, promotes postural stability and increases overall sitting tolerance. Preliminary work investigated a range of novel low-cost dynamically responsive materials developed for the non-medical market and which showed potential for use in seating design. A key aspect of the modular cushion's design is its ability to be fitted and customized for each user using a cushion fitting algorithm (CFA). The modular array thus optimizes pressure distribution over the cushion surface while the user is sitting. Using the CFA, each cushion can be personalized for the user to optimize interface pressure distribution and maintain seated tissue health. The current project will provide next-generation development and user evaluation of a low-cost advanced modular pressure relief cushion and fitting algorithm, building on the previous support from VA. The first generation modular cushion was designed for power wheelchair users, the second generation will be lower weight and also suitable for manual wheelchair users. Low cost compressible SquishINS inserts will be additively manufactured using commercially available silicon by modified desktop Makerbot Replicator printers (StrataSys, Brooklyn, NY). Pre-clinical benchmark evaluation will be carried out using ISO 16840-2 testing standards. Cost analysis will ensure that the next- generation modular cushion continues to apply value-driven principles. A clinical pilot study of 30 Veterans who are full-time wheelchair users will be carried out using a repeated measures clinical study design, with study participants as their own controls. `Pre-baseline' seated interface pressures will be assessed with study participants sitting on their own cushions and pelvic region skin checks carried out by the study Research Nurse. All participants will then receive customized modular cushions fit to the user using the CFA to create a personalized cushion insert layouts. Participants will be randomly assigned to Group A or Group B using a modified randomization scheme. Group A participants will first use a gel ball fitted cushion for 2 weeks during all daily living activities while seated in their wheelchair followed by use of a SquishINS fitted cushion for 2 weeks. Group B will first use the SquishINS fitted cushion then a gel ball fitted cushion. Seated interface pressure distribution will be obtained with the fitted cushion at the beginning and end of each test period. A dual temperature and humidity sensor placed in the cushion will enable continuous monitoring of microenvironmental status during use for download at the end of each test period. The study Research Nurse will also repeat the pelvic region skin check and participants will complete a questionnaire based on the QUEST 2.0 user satisfaction instrument. All responses will be documented as part of the QS/DC program. Our pre-clinical development and user evaluation will provide a strong foundation for translation of personalized low-cost high-performance modular cushions for effective seated pressure redistribution in wheelchair users.

对于许多行动不便的人来说，压力性损伤是一个重要的继发性并发症， 包括老年退伍军人和脊髓损伤 (SCI) 患者。人员核心辅助技术 行动不便的人士包括轮椅座椅系统，包括轮椅和轮椅 有效的减压垫。所有轮椅使用者骨盆区域的风险都会增加 坐着时受压受伤。大量研究表明，虽然没有一种坐垫能够满足 满足每个用户的需求，减压坐垫是所有轮椅座椅的关键组件 最大限度地提高行动不便人士的功能并降低压力风险的系统 损伤的发展。有效的坐垫可防止组织分解、促进姿势稳定性和 增加整体坐姿耐受力。 初步工作研究了一系列新型低成本动态响应材料 非医疗市场，并显示出在座椅设计中的应用潜力。的一个关键方面是 模块化坐垫的设计在于它能够使用坐垫配件为每个用户进行安装和定制 算法（CFA）。因此，模块化阵列优化了垫子表面上的压力分布，同时 用户坐着。使用 CFA，每个垫子都可以为用户进行个性化优化界面 压力分布并保持就位组织健康。 当前的项目将提供下一代开发和用户评估的低成本 先进的模块化减压垫和贴合算法，建立在之前的支持之上 弗吉尼亚州。第一代模块化坐垫专为电动轮椅使用者设计，第二代 一代将重量更轻，也适合手动轮椅使用者。低成本可压缩 SquishINS 刀片将使用经过改良的商用硅进行增材制造 桌面 Makerbot Replicator 打印机（StrataSys，布鲁克林，纽约）。临床前基准评估将 使用 ISO 16840-2 测试标准进行。成本分析将确保下一代 模块化坐垫继续应用价值驱动的原则。一项针对 30 名退伍军人的临床试点研究 全职轮椅使用者将采用重复测量临床研究设计进行， 研究参与者作为自己的对照。 “基线前”就位界面压力将通过以下方式进行评估 研究参与者坐在自己的垫子上，并进行研究进行的骨盆区域皮肤检查 研究护士。然后，所有参与者都将收到适合用户的定制模块化坐垫，使用 CFA 创建个性化的坐垫插入布局。参与者将被随机分配到A组 或 B 组使用修改后的随机化方案。 A组参赛者将首先使用安装的凝胶球 坐在轮椅上，在所有日常生活活动中使用坐垫两周，然后使用 SquishINS 坐垫可使用 2 周。 B 组将首先使用 SquishINS 安装垫，然后使用凝胶 球垫。就座界面压力分布将通过在安装垫处获得 每个测试周期的开始和结束。放置在坐垫内的温度和湿度双传感器 将能够在使用过程中持续监测微环境状态，并在结束时下载 每个测试期。研究护士还将重复骨盆区域皮肤检查和 参与者将完成基于 QUEST 2.0 用户满意度工具的调查问卷。全部 回应将被记录为 QS/DC 计划的一部分。 我们的临床前开发和用户评估将为翻译提供坚实的基础 个性化的低成本高性能模块化坐垫，可有效重新分配坐姿压力 轮椅使用者。