Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-08
Study Completion Date
2026-08-31
Brief Summary
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This research study is being done 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 the user to assist with their own transfers to/from bed or chair to the PPAL for toileting, with little manual help provided by user's caregivers. Users who require assistance with transfers and their caregivers have a high likelihood of experiencing and 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 in a 6-week at home trial. Participants will be asked to schedule a home visit with the research team to screen their home and ask questions and observe the participant's current transfer methods to their toilet/commode to ensure that they and the caregiver are an appropriate candidate 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 6-week trial, the study team will arrange a final study visit date 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 the caregiver to ask them about their satisfaction with device. This interview will be audio recorded.
This study involves minimal risks which are expected to occur infrequently. There is the possibility that the participant could obtain a scrape, bruise, cut or pinch injury as you will be working with a device that they are not familiar with. 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 your use of it to minimize this risk. There is a risk of breach of confidentiality as text messages and emails may not be encrypted or secure during their transmission or storage and it is possible they could be intercepted and used by others not associated with this study.
There will be no direct benefit to the participant from participating in the study, but it will help the developers of the PPAL better understand the opinions, needs and abilities of the caregivers and patients who may use the device.
The purpose of this study is to evaluate the PPAL bedside commode in a home setting to better understand the impact of the device in a 6-week at home trial. Participants will be asked to schedule a home visit with the research team to screen their home and ask questions and observe the participant's current transfer methods to their toilet/commode to ensure that they and the caregiver are an appropriate candidate 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 6-week trial, the study team will arrange a final study visit date 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 the caregiver to ask them about their satisfaction with device. This interview will be audio recorded.
This study involves minimal risks which are expected to occur infrequently. There is the possibility that the participant could obtain a scrape, bruise, cut or pinch injury as you will be working with a device that they are not familiar with. 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 your use of it to minimize this risk. There is a risk of breach of confidentiality as text messages and emails may not be encrypted or secure during their transmission or storage and it is possible they could be intercepted and used by others not associated with this study.
There will be no direct benefit to the participant from participating in the study, but it will help the developers of the PPAL better understand the opinions, needs and abilities of the caregivers and patients who may use the device.
Detailed Description
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Conditions
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Age Problems
Keywords
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Activities of daily living
Falls
Assistive technologies
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a single group longitudinal intervention study, conducted using descriptive survey design and data logs by the user.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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PPAL user
This is the experimental group. These participants will trial the PPAL.
Group Type
EXPERIMENTAL
PPAL
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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
* 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.
* 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
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.
-Physical limitations that prevent caregiver from manually assisting with PPAL transfer or from maneuvering the PPAL around the end-user's residence
* 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.
-Physical limitations that prevent caregiver from manually assisting with PPAL transfer or from maneuvering the PPAL around the end-user's residence
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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QUA Inc.
UNKNOWN
Sponsor Role
collaborator
National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
Alicia Koontz
OTHER
Sponsor Role
lead
Responsible Party
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Alicia Koontz
Professor - School of Health and Rehabilitation Science
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Alicia M Koontz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh: Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
Central Contacts
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY25010091
Identifier Type: -
Identifier Source: org_study_id