Evaluation of the PPAL

Official title

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

Overview

This research study is being conducted to better understand the impact of the PPAL assisted toileting device. The PPAL consists of a powered, height-adjustable commode chair with integrated transfer boards. The system is designed to allow users to assist with their own transfers to and from the bed or chair to the PPAL for toileting, with minimal manual assistance from caregivers. Users who require assistance with transfers, and their caregivers, have a high likelihood of experiencing injury during transfers. The purpose of this study is to evaluate the PPAL bedside commode in a home setting to better understand the impact of the device during a six-week at-home trial. Participants will be asked to schedule a home visit with the research team to screen their home, answer questions, and observe the participant's current transfer methods to their toilet or commode to ensure that both the participant and caregiver are appropriate candidates for the device. Once approved, a delivery date will be arranged to deliver the PPAL to the participant's home. At the end of the six-week trial, the study team will arrange a final visit to retrieve the PPAL and again ask questions and observe a toilet transfer using both the PPAL and the customary commode. Finally, the investigators will interview the participant and caregiver to assess their satisfaction with the device. This interview will be audio recorded. This study involves minimal risks, which are expected to occur infrequently. There is a possibility that the participant could experience a scrape, bruise, cut, or pinch injury while using a device with which they are not familiar. There is also the possibility that the participant could fall when attempting to transfer to or from the device; however, the investigators will thoroughly demonstrate the device and monitor its use to minimize this risk. There is also a risk of breach of confidentiality, as text messages and emails may not be encrypted or secure during transmission or storage, and it is possible they could be intercepted or accessed by individuals not associated with this study. There will be no direct benefit to the participant from participating in the study, but participation will help developers of the PPAL better understand the opinions, needs, and abilities of caregivers and patients who may use the device.

Interventions

• Device PPAL
  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.

Primary outcome measures

• Change in fall efficacy with connection to toileting [Time frame: Change from pre to post 6 week trial]

Secondary outcome measures (2)

• Change in GG Self-Care score for Toilet Transfer [Time frame: Change from pre to post 6 week trial]
• System Usability Scale (SUS) [Time frame: At the end of the 6 week trial]

Eligibility criteria

Toileter Inclusion Criteria:

• Age 18 years or above
• Weighs 300 pounds or less and is able to fit within the dimensions of the PPAL - Has difficulty with getting on or off a toilet or commode at any point in a typical 24-hour period
• Resides in either a home, independent living residence, assisted living or extended care residence
• Able to maintain sitting balance independently (without human assistance) for at least 2 minutes
• If sitting for longer than 2 minutes (with or without assistance), does not get dizzy or lightheaded
• Residence is able to accommodate the PPAL in the Bedroom or designated space.

Toileter Exclusion Criteria:

• Ventilator users
• Free of acute medical events within the last 3 months
• Had Stage 2 or greater pressure ulcer within the last 3 months
• Upcoming planned medical procedures or surgeries in the next 3 months.

Caregiver Inclusion Criteria:

• Age 18 years or above
• Formal/paid or informal/unpaid caregiver for the patient participant (toileter) who provides toileting assistance at least 3 days per week

Caregiver Exclusion Criteria:

-Physical limitations that prevent caregiver from manually assisting with PPAL transfer or from maneuvering the PPAL around the end-user's residence

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Pittsburgh: Human Engineering Research Laboratories — Pittsburgh

Publications

• Okoli C, Pawlowski SD. The Delphi method as a research tool: an example, design considerations and applications. Information & management. 2004;42(1):15-29.
• Brown BB. Delphi process: a methodology used for the elicitation of opinions of experts. Rand Corp Santa Monica CA; 1968.
• Moreland B, Kakara R, Henry A. Trends in Nonfatal Falls and Fall-Related Injuries Among Adults Aged >/=65 Years - United States, 2012-2018. MMWR Morb Mortal Wkly Rep. 2020 Jul 10;69(27):875-881. doi: 10.15585/mmwr.mm6927a5. PMID 32644982
• Rice L, Kalron A, Berkowitz SH, Backus D, Sosnoff JJ. Fall prevalence in people with multiple sclerosis who use wheelchairs and scooters. Medicine (Baltimore). 2017 Sep;96(35):e7860. doi: 10.1097/MD.0000000000007860. PMID 28858096
• Kulich HR, Bass SR, Koontz AM. Rehabilitation professional and user evaluation of an integrated push-pull lever drive system for wheelchair mobility. Assist Technol. 2024 Sep;36(5):329-337. doi: 10.1080/10400435.2020.1836068. Epub 2020 Nov 12. PMID 33079646
• Kulich HR, Bass SR, Griscavage JS, Vijayvargiya A, Slowik JS, Koontz AM. An ergonomic comparison of three different patient transport chairs in a simulated hospital environment. Appl Ergon. 2020 Oct;88:103172. doi: 10.1016/j.apergo.2020.103172. Epub 2020 Jun 8. PMID 32678780
• Macefield R. How to specify the participant group size for usability studies: a practitioner's guide. Journal of Usability Studies. 2009;5(1):34-45.
• Demers L, Weiss-Lambrou R, Ska B. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): An overview and recent progress. Technology and Disability. 2002;14:101-5.

Identifiers

NCT: NCT07221552 · STUDY25100178 · 5R44NR019516-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗