Age ProblemsNCT07221552
Evaluation of the PPAL
A study testing PPAL in people with Age Problems, run by Alicia Koontz at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Problems
- What is being tested?
- PPAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Edward J McClain, MA contact
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh: Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, 15206
Nikitha Deepak, MS, 412-407-2047, NID51@pitt.edu
Edward J McClain, MA, 412-407-2047, tjm290@pitt.edu
About this study
Official title: Development and Evaluation of PPAL Bedside Commode for Safe Independent Toileting Transfers
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.
Read more
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.
- Conditions
- Age Problems
- Being tested
- PPAL
- Keywords
- Activities of daily living, Falls, Assistive technologies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPALDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PPAL User | Experimental | Not described Receives: Device: PPAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fall efficacy with connection to toileting
We aim to determine whether the use of PPAL reduces fear of falling during toileting activities. To assess this, we will utilize the Fall Concerns Scale for individuals who use Wheelchairs and Scooters (FCS-WC/S). Items are scored on a scale of concern, with 1 being "Not at all concerned" and 4 being "Very Concerned". Scores can be analyzed from specific questions, or the questionnaire as a whole. For this result we will focus on the item specifically associated with getting on/off of a toilet or commode at home. A decrease in FCS-WC/S scores at the end of the study would indicate a reduction in fear of falling.
Measured: Change from pre to post 6 week trial
Secondary outcomes (2)
Change in GG Self-Care score for Toilet Transfer
We aim to observe a change in the GG Self-Care score for toilet transfers, specifically an improvement in the individual's ability to safely get on and off a toilet or commode. This item is scored on a scale from 1 (Dependent: completely reliant on a caregiver) to 6 (Independent: no assistance required). An increase in this score would indicate improved functional independence.
Measured: Change from pre to post 6 week trial
System Usability Scale (SUS)
We aim to find that PPAL will have at minimum an acceptable level of usability at the end of the trial. The SUS consists of items rated on a scale of 1 (strongly disagree) to 5 (strongly agree), assessing the participants perceived usability of the system in several domain areas. A total score is computed and a score of 68 or higher would be indicative of acceptable usability (scores ranging from 0 to 100 with higher scores indicating better usability).
Measured: At the end of the 6 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start20 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Age ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group longitudinal intervention study, conducted using descriptive survey design and data logs by the user.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alicia Koontz
- Sponsor type
- University, hospital or other
- Collaborators
- QUA Inc., National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Alicia Koontz, University of Pittsburgh
- Investigators
- Alicia M Koontz, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221552
- Sponsor's protocol ID
- STUDY25100178
- Other IDs
- 5R44NR019516-03
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
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.
PubMed 32644982Rice 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.
PubMed 28858096Kulich 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.
PubMed 33079646Kulich 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.
PubMed 32678780Macefield 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.
Mortenson WB, Demers L, Fuhrer MJ, Jutai JW, Lenker J, DeRuyter F. Development and preliminary evaluation of the caregiver assistive technology outcome measure. J Rehabil Med. 2015 May;47(5):412-8. doi: 10.2340/16501977-1952.
PubMed 25783142Boswell-Ruys CL, Harvey LA, Delbaere K, Lord SR. A Falls Concern Scale for people with spinal cord injury (SCI-FCS). Spinal Cord. 2010 Sep;48(9):704-9. doi: 10.1038/sc.2010.1. Epub 2010 Feb 2.
PubMed 20125107Hittle DF, Shaughnessy PW, Crisler KS, Powell MC, Richard AA, Conway KS, Stearns PM, Engle K. A Study of Reliability and Burden of Home Health Assessment Using OASIS. Home Health Care Serv Q. 2004 Feb 2;22(4):43-63. doi: 10.1300/J027v22n04_03.
PubMed 29016255Shew PA, Sanders SL, Arthur NC, Bush KW. OASIS inter-rater reliability and reimbursement: a study of inter-rater reliability of the Outcome and Assessment Information Set (OASIS): its effects on the Home Health Resource Group (HHRG) and reimbursement. Home Healthc Nurse. 2010 Jan;28(1):31-6. doi: 10.1097/01.NHH.0000366795.71528.ac.
PubMed 20032729Sundaram SA, Chung CS, Gebrosky B, Brown J, Grindle GG, Deepak N, Cooper R, Cooper RA. Participatory action design and engineering of a manual wheelchair virtual coach including in-home and community usage. J Spinal Cord Med. 2023 Jul;46(4):546-559. doi: 10.1080/10790268.2022.2107352. Epub 2022 Aug 22.
PubMed 35994022Daveler B, Gebrosky B, Eckstein I, Cooper R, Grindle GG, Cooper RA. Air-powered shopping carts in grocery stores: a pilot study. Disabil Rehabil Assist Technol. 2022 Jan;17(1):116-122. doi: 10.1080/17483107.2020.1767221. Epub 2020 May 19.
PubMed 32427527Daveler B, Wang H, Gebrosky B, Grindle GG, Schneider U, Cooper RA. Integration of Pneumatic Technology in Powered Mobility Devices. Top Spinal Cord Inj Rehabil. 2017 Spring;23(2):120-130. doi: 10.1310/sci2302-120.
PubMed 29339888
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of PPAL Bedside Commode for Safe Independent Toileting Transfers
- ClinicalTrials.gov ID
- NCT07221552
- Acronym / sponsor ID
- STUDY25100178
- Conditions
- Age Problems
- Keywords
- Activities of daily living, Falls, Assistive technologies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Alicia KoontzUniversity, hospital or other
- Collaborators
- QUA Inc., National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group longitudinal intervention study, conducted using descriptive survey design and data logs by the user.
| Arm | Type | Receives |
|---|---|---|
| PPAL User | Experimental | Device: PPAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPALPPAL 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. | Device | PPAL User |
Primary outcome
Change in fall efficacy with connection to toileting
Time frame: Change from pre to post 6 week trial
We aim to determine whether the use of PPAL reduces fear of falling during toileting activities. To assess this, we will utilize the Fall Concerns Scale for individuals who use Wheelchairs and Scooters (FCS-WC/S). Items are scored on a scale of concern, with 1 being "Not at all concerned" and 4 being "Very Concerned". Scores can be analyzed from specific questions, or the questionnaire as a whole. For this result we will focus on the item specifically associated with getting on/off of a toilet or commode at home. A decrease in FCS-WC/S scores at the end of the study would indicate a reduction in fear of falling.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- BackgroundOkoli C, Pawlowski SD. The Delphi method as a research tool: an example, design considerations and applications. Information & management. 2004;42(1):15-29.
- BackgroundBrown BB. Delphi process: a methodology used for the elicitation of opinions of experts. Rand Corp Santa Monica CA; 1968.
- Background: PubMed 32644982Moreland 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.
- Background: PubMed 28858096Rice 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.
- Background: PubMed 33079646Kulich 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.
- Background: PubMed 32678780Kulich 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.
- BackgroundMacefield R. How to specify the participant group size for usability studies: a practitioner's guide. Journal of Usability Studies. 2009;5(1):34-45.
- BackgroundDemers 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.
- Background: PubMed 25783142Mortenson WB, Demers L, Fuhrer MJ, Jutai JW, Lenker J, DeRuyter F. Development and preliminary evaluation of the caregiver assistive technology outcome measure. J Rehabil Med. 2015 May;47(5):412-8. doi: 10.2340/16501977-1952.
- Background: PubMed 20125107Boswell-Ruys CL, Harvey LA, Delbaere K, Lord SR. A Falls Concern Scale for people with spinal cord injury (SCI-FCS). Spinal Cord. 2010 Sep;48(9):704-9. doi: 10.1038/sc.2010.1. Epub 2010 Feb 2.
- Background: PubMed 29016255Hittle DF, Shaughnessy PW, Crisler KS, Powell MC, Richard AA, Conway KS, Stearns PM, Engle K. A Study of Reliability and Burden of Home Health Assessment Using OASIS. Home Health Care Serv Q. 2004 Feb 2;22(4):43-63. doi: 10.1300/J027v22n04_03.
- Background: PubMed 20032729Shew PA, Sanders SL, Arthur NC, Bush KW. OASIS inter-rater reliability and reimbursement: a study of inter-rater reliability of the Outcome and Assessment Information Set (OASIS): its effects on the Home Health Resource Group (HHRG) and reimbursement. Home Healthc Nurse. 2010 Jan;28(1):31-6. doi: 10.1097/01.NHH.0000366795.71528.ac.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward J McClain, MA contact
Alicia M Koontz, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPAL in people with Age Problems, run by Alicia Koontz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikitha Deepak, MS (412-822-3669, NID51@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fall efficacy with connection to toileting (time frame: Change from pre to post 6 week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221552, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.