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: 9901367
• 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 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9901367
• 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; 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.

压力损伤对于许多迁移率降低的人来说是重要的次要并发症， 包括老年退伍军人和脊髓损伤的人（SCI）。人的核心辅助技术 机动性有限，包括轮椅座椅系统，包括轮椅和 有效的压力缓解垫。所有轮椅使用者都有骨盆区域的风险增加 坐着时受到压力伤害。许多研究表明，尽管没有一个垫子可以满足 每个用户的需求，减压垫子是全轮椅座椅的关键组成部分 为具有行动率限制并降低压力风险的个人最大化功能的系统 伤害发展。有效的缓冲可防止组织分解，促进姿势稳定性和 增加整体坐姿。 初步工作调查了一系列新型低成本动态响应材料 非医疗市场，显示出在座位设计中使用的潜力。一个关键方面 模块化垫的设计是使用垫子配件为每个用户进行安装和定制的能力 算法（CFA）。因此，模块化阵列优化了靠垫表面的压力分布 用户坐着。使用CFA，可以个性化每个垫子以供用户优化接口 压力分布并保持座椅健康。 当前项目将提供下一代开发和低成本的用户评估 先进的模块化压力缓解垫和安装算法，以先前的支持为基础 VA。第一代模块化垫是为电动轮椅使用者设计的 生成的重量较低，也适合手动轮椅使用者。低成本可压缩 Squishins插入物将通过修改 桌面Makerbot复制器打印机（Stratasys，Brooklyn，NY）。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 模块化垫继续应用价值驱动的原理。一项对30名退伍军人的临床试点研究 全职轮椅使用者将使用重复措施进行临床研究设计，并以 研究参与者作为自己的控制。 ``基本前''座位界面压力将通过 研究参与者坐在自己的靠垫和骨盆区域皮肤检查上进行的研究参与者进行了研究 研究护士。然后，所有参与者都将使用该垫子收到适合用户的自定义模块化垫子 CFA创建个性化的垫子插入布局。参与者将被随机分配给A组 或B组使用修改的随机化方案。 A组参与者将首先使用安装的凝胶球 坐在轮椅上的所有日常生活活动中，垫子持续了2周，然后使用 鱿鱼安装了垫子2周。 B组将首先使用安装垫子然后凝胶 球安装垫子。坐着的界面压力分布将通过安装的垫子在 每个测试期的开始和结束。垫子中放置的双重温度和湿度传感器 将在使用期间连续监视微环境状态 每个测试期。研究研究护士还将重复骨盆区域的皮肤检查和 参与者将根据任务2.0用户满意度工具填写问卷。全部 响应将记录为QS/DC程序的一部分。 我们的临床前开发和用户评估将为翻译的坚实基础 个性化的低成本高性能模块化垫子，可有效座椅压力重新分布 轮椅使用者。