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

NIH RePORTER · VA · I01 · · view on reporter.nih.gov ↗

Abstract

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 wi...

Key facts

NIH application ID
10910106
Project number
5I01RX002434-07
Recipient
LOUIS STOKES CLEVELAND VA MEDICAL CENTER
Principal Investigator
KATH BOGIE
Activity code
I01
Funding institute
VA
Fiscal year
2024
Award amount
Award type
5
Project period
2018-05-01 → 2025-12-31