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，压力损伤是一种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。核心辅助技术 包括轮椅座椅系统，包括轮椅和 有效的减压垫。所有轮椅使用者的骨盆区域的风险增加 坐着时的压力。许多研究表明，虽然没有一个垫子可以满足 每个用户的需求，压力缓解垫是一个关键组成部分，在所有轮椅座椅 最大限度地发挥行动受限人员的功能并降低压力风险的系统 伤害发展。有效的缓冲防止组织破裂，促进姿势稳定性， 增加整体坐姿耐受性。 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使用的潜力。的一个关键方面 模块化垫的设计是它的能力，以配合和定制为每个用户使用垫配件 算法（CFA）。因此，模块化阵列优化了衬垫表面上的压力分布， 用户坐着。使用CFA，每个靠垫都可以为用户优化个性化界面 压力分布和保持固定组织健康。 目前的项目将提供下一代开发和用户评估的低成本 先进的模块化压力释放垫和配件算法，建立在以前的支持， 弗吉尼亚第一代模块化坐垫是为电动轮椅使用者设计的， 新一代的轮椅重量更轻，也适合手动轮椅使用者。低成本可压缩 SquishINS插入物将通过改良的方法使用市售硅进行增材制造 桌面Makerbot Replicator打印机（StrataSys，Brooklyn，NY）。临床前基准评价将 使用ISO 16840 - 2测试标准进行测试。成本分析将确保下一代 模块化缓冲垫继续采用价值驱动原则。对30名退伍军人进行的临床试点研究 全职轮椅使用者将采用重复测量临床研究设计， 研究参与者作为自己的控制。"基线前"就座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，并通过研究进行骨盆区域皮肤检查 研究护士然后，所有参与者都将获得适合用户的定制模块化靠垫， CFA为您打造个性化的坐垫衬垫布局。参与者将被随机分配到A组 或B组，使用修改的随机化方案。A组的参与者将首先使用一个凝胶球安装 坐在轮椅上进行所有日常生活活动时，使用2周的垫子， SquishINS安装了2周的垫子。B组将首先使用SquishINS贴合垫，然后使用凝胶 球垫。将通过安装垫在以下位置获得坐置界面压力分布： 每个测试周期的开始和结束。一个双温湿度传感器放置在垫子上 将能够在使用过程中持续监测微环境状态，以便在使用结束时下载 每个测试周期。研究护士还将重复盆腔区域皮肤检查， 参与者将根据QUEST 2.0用户满意度工具完成一份问卷。所有 响应将作为QS/DC程序的一部分进行记录。 我们的临床前开发和用户评估将为翻译 个性化的低成本高性能模块化座垫， 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.