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.