Development and Evaluation of the PPAL Bedside Commode for Safe Independent Toileting Transfers

项目摘要：PPAL®第二阶段 洗手间对老年人和轮椅使用者来说是极其危险的。洗手间受伤，许多与 如厕，在≥85岁的人中以每100,000人中266.6的比率发生，并导致昂贵的、伤害性的跌倒 以及众多连锁的不利健康后果。转让辅助技术是重要的工具， 可以用来促进健康、独立、社区参与和生活质量。新的、易于使用的 为病人和照顾者提供更高效、更安全的厕所转移的技术正处于绝望之中 需要的。该SBIR第二阶段项目建议改进和评估PPAL®，这是一种辅助厕所设备， 使与厕所有关的跌倒风险的人能够安全地转移，而不需要护理者提供更少的物理帮助。 拟议的第二阶段活动将完善和测试由美国国立卫生研究院开发的概念验证原型 PPAL是一款获得专利的电动可调高度床边马桶，集成了 转接板。PPAL包含一个传送板，可以随着椅子座椅的升降或 降低，以便用户始终可以执行下坡传输。这项创新将使有限的个人 目前依赖照顾者帮助才能更独立地转移的机动性患者。这也将降低风险。 对于使用者和照顾者来说，跌倒和受伤是最重要的。第一阶段的结果表明，为了提高可制造性和 商业潜力，最初的原型应该为轮椅使用者提供更合适的高度水平 (WCU)，增加了座椅和定位功能，以及更灵活、更时尚的底座，可以保持在 在床边。拟议的第二阶段研究围绕三个目标进行。在目标1中，我们将开发一个预生产 能够在轮椅或床与PPAL之间进行水平和下坡转移的原型适用于 机构和家庭使用，专为可制造性而设计。这将通过进行设计来实现 与利益相关者进行评审，为可制造性进行设计，并根据 标准，与利益相关者一起在实验室进行评估，并根据反馈修改原型 收到了。在目标2中，我们将评估PPAL在现实世界家庭环境和短期环境中的可用性和实用性 对跌倒/险些跌倒的发生率、如厕辅助水平、对跌倒的恐惧和照顾者负担的影响。PPAL将 被安置在WCU及其正式或非正式照顾者的住所。结果将在基线上进行评估 在为期6周的设备试验结束时。AIM 3将开发和验证PPAL使用的临床指南。 由专家临床医生和安全患者处理和转移(SPHM)组成的跨学科利益相关者小组 将召集专业人员协助确定PPAL安全处方的临床参数。 该项目的长期商业目标是提供一种厕所解决方案，从而提高用户的独立性 并减少使用者和照顾者的伤害。PPAL将适合部署在家庭中，熟练的护理 以及康复设施和医院。

Project Summary: PPAL® Phase II Bathrooms are extremely hazardous for older adults and wheelchair users. Bathroom injuries, many related to toileting, occur at a rate of 266.6 per100,000 among persons aged ≥85 years and result in costly, injurious falls and numerous cascading adverse health consequences. Transfer assisting technologies are important tools that can be used to promote wellness, independence, community participation, and quality of life. New, easy-to-use technologies that enable more efficient and safer toilet transfers for patients and caregivers are desperately needed. This SBIR Phase II project proposes to refine and evaluate PPAL®, an assisted toileting device that enables persons at risk for toileting-related falls to safely transfer with less physical assistance from a caregiver. The proposed Phase II activities will refine and test theproof-of-concept prototype developed under an NIH Phase I project by QUA, Inc. PPAL is a patented, motorized, height adjustable bedside commode with integrated transfer boards. PPAL incorporates a transfer board that moves up and down as the Chair seat is raised or lowered so that the user can always perform a downhill transfer. This innovation will allow individuals with limited mobility who currently rely on caregiver assistance to transfer more independently. It will also decrease the risk of falls and injuries for users and caregivers. Phase I results show that to improve manufacturability and commercial potential, the initial prototype should offer more appropriate height levels for wheelchair users (WCUs), added seating and positioning features, and a more maneuverable, sleeker base that can be kept at bedside. The proposed Phase II study is organized around three aims. In Aim 1, we will develop a pre-production prototype that enables level and downhill transfers between a wheelchair or bed and the PPAL, is suitable for institutional and home use, and is designed for manufacturability. This will be accomplished by conducting design reviews with stakeholders, designing for manufacturability, conducting engineering testing in accordance with standards, performing in lab evaluations with stakeholders, and revising the prototypes based on feedback received. In Aim 2, we will assess the usability and utility of PPAL in real-world home settings and short-term impact on fall/near fall incidence, level of toileting assistance, fear of falling and caregiver burden. The PPAL will be placed in residences of WCUs and their formal or informal caregivers. Outcomes will be assessed at baseline and at the conclusion of a 6-week device trial. Aim 3 will develop and validate clinical guidelines for PPAL use. An interdisciplinary stakeholder group of expert clinicians and Safe Patient Handling and Movement (SPHM) professionals will be convened to assist with identifying clinical parameters for the safe prescription of the PPAL. The long-term commercial goal of the project is to provide a toileting solution that will increase user independence and decrease both user and caregiver injury. The PPAL will be suitable for deployment in homes, skilled nursing and rehabilitation facilities as well as hospitals.