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

对于许多行动不便的人来说，压力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。人的核心辅助技术 行动不便的人包括轮椅座椅系统，包括轮椅和 有效的泄压垫。所有轮椅使用者患盆腔疾病的风险都有所增加。 坐着时受压伤。大量研究表明，尽管没有一个垫子可以满足 每个使用者的需求，减压垫是所有轮椅座椅的关键部件 系统最大限度地为行动受限的个人提供功能，并降低压力风险 伤害的发展。有效的坐垫防止组织分解，促进姿势稳定和 增加整体的坐姿耐受性。 初步工作研究了一系列新的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潜力。一个关键的方面是 模块化坐垫的设计是它能够使用坐垫配件为每个用户进行安装和定制 算法(CFA)。模块阵列因此优化了垫面上的压力分布，同时 用户正在坐着。使用CFA，可以对每个坐垫进行个性化，以供用户优化界面 压力分布和保持坐位组织健康。 目前的项目将提供下一代开发和用户评估的低成本 先进的模块化卸压缓冲和装配算法，建立在以前支持的基础上 弗吉尼亚州第一代模块化坐垫是为电动轮椅用户设计的，第二代 新一代轮椅重量更轻，也适用于手动轮椅用户。低成本可压缩 SquishINS插件将使用商业上可获得的硅通过修改添加制造 台式Makerbot复制器打印机(Stratasys，Brooklyn，NY)。临床前基准评估将 使用国际标准化组织16840-2测试标准进行测试。成本分析将确保下一代 模块化缓冲继续应用价值驱动的原则。30名退伍军人的临床初步研究 全职轮椅使用者将使用重复测量临床研究设计进行， 研究参与者作为他们自己的对照。“基线前”座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坐垫上，并由研究人员进行骨盆区域皮肤检查 研究护士。然后，所有参与者都将收到适合用户使用的定制模块化坐垫 CFA创建个性化的坐垫插页布局。参赛者将随机分配到A组 或B组，采用改进的随机化方案。A组参赛者将首先使用安装好的凝胶球 在所有日常生活活动中，坐在轮椅上两周，然后使用 SquishINs加垫2周。B组将首先使用SquishINS安装的垫子，然后使用凝胶 带球的坐垫。在安装了气垫的情况下，将获得座位界面的压力分布 每个测试期的开始和结束。在垫子中放置一个双温湿度传感器 将能够在使用过程中持续监测微环境状态，以便在 每个测试期。研究护士还将重复盆腔区域皮肤检查和 参与者将完成一份基于Quest 2.0用户满意度工具的调查问卷。全 答复将作为QS/DC计划的一部分进行记录。 我们的临床前开发和用户评估将为翻译 个性化、低成本、高性能的模块化缓冲，可实现有效的座椅压力重新分配 轮椅使用者。

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.