Evaluation of the PPAL

NCT07221552 | Recruiting FDA Device

• 2 other identifiers: STUDY251001785R44NR019516-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Age Problems

Keywords

Activities of daily living; Falls; Assistive technologies

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from pre to post 6 week trial

Secondary Outcomes (2)

• Change in GG Self-Care score for Toilet Transfer

  Change from pre to post 6 week trial

• System Usability Scale (SUS)

  At the end of the 6 week trial

Study Arms (1)

PPAL User

EXPERIMENTAL

Device: PPAL

Interventions

PPAL 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.

PPAL User

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alicia Koontz: lead
• QUA Inc.: collaborator
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Pittsburgh: Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

RECRUITING

Related Publications (55)

• Okoli C, Pawlowski SD. The Delphi method as a research tool: an example, design considerations and applications. Information & management. 2004;42(1):15-29.

  BACKGROUND

• Brown BB. Delphi process: a methodology used for the elicitation of opinions of experts. Rand Corp Santa Monica CA; 1968.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25783142 BACKGROUND

• Boswell-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.

  PMID: 20125107 BACKGROUND

• Hittle 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.

  PMID: 29016255 BACKGROUND

• Shew 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.

  PMID: 20032729 BACKGROUND

• Sundaram 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.

  PMID: 35994022 BACKGROUND

• Daveler 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.

  PMID: 32427527 BACKGROUND

• Daveler 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.

  PMID: 29339888 BACKGROUND

• Grindle GG, Wang H, Jeannis H, Teodorski E, Cooper RA. Design and user evaluation of a wheelchair mounted robotic assisted transfer device. Biomed Res Int. 2015;2015:198476. doi: 10.1155/2015/198476. Epub 2015 Feb 22.

  PMID: 25793190 BACKGROUND

• Virzi RA. Refining the Test Phase of Usability Evaluation: How Many Subjects Is Enough? Human Factors. 1992;34(4):457-68.

  BACKGROUND

• Gagnon MP, Orruno E, Asua J, Abdeljelil AB, Emparanza J. Using a modified technology acceptance model to evaluate healthcare professionals' adoption of a new telemonitoring system. Telemed J E Health. 2012 Jan-Feb;18(1):54-9. doi: 10.1089/tmj.2011.0066. Epub 2011 Nov 14.

  PMID: 22082108 BACKGROUND

• Friesen EL. Measuring AT Usability with the Modified System Usability Scale (SUS). Stud Health Technol Inform. 2017;242:137-143.

  PMID: 28873790 BACKGROUND

• Sauro J. Measuring Usability with the System Usability Scale (SUS) Measuring 2011

  BACKGROUND

• Hyman WA. A generic fault tree for medical device error. Journal of Clinical Engineering. 2002;27(2):134-40.

  BACKGROUND

• Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018 Oct 8;8(10):e019993. doi: 10.1136/bmjopen-2017-019993.

  PMID: 30297341 BACKGROUND

• Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.

  PMID: 30709368 BACKGROUND

• Huq MS, Fraass BA, Dunscombe PB, Gibbons JP Jr, Ibbott GS, Medin PM, Mundt A, Mutic S, Palta JR, Thomadsen BR, Williamson JF, Yorke ED. A method for evaluating quality assurance needs in radiation therapy. Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S170-3. doi: 10.1016/j.ijrobp.2007.06.081.

  PMID: 18406920 BACKGROUND

• Gebrosky B, Pearlman J, Cooper R. Comparison of High-Strength Aluminum Ultralight Wheelchairs Using ANSI/RESNA Testing Standards. Top Spinal Cord Inj Rehabil. 2018 Winter;24(1):63-77. doi: 10.1310/sci16-00057. Epub 2017 Nov 20.

  PMID: 29434462 BACKGROUND

• Gebrosky B, Pearlman J, Cooper RA, Cooper R, Kelleher A. Evaluation of lightweight wheelchairs using ANSI/RESNA testing standards. J Rehabil Res Dev. 2013;50(10):1373-89. doi: 10.1682/JRRD.2012.08.0155.

  PMID: 24699973 BACKGROUND

• Steinfeld E, Maisel J, Feathers D, D'Souza C. Anthropometry and standards for wheeled mobility: an international comparison. Assist Technol. 2010 Spring;22(1):51-67. doi: 10.1080/10400430903520280.

  PMID: 20402047 BACKGROUND

• Noble NL, Sweeney NL. Barriers to the Use of Assistive Devices in Patient Handling. Workplace Health Saf. 2018 Jan;66(1):41-48. doi: 10.1177/2165079917697216. Epub 2017 May 9.

  PMID: 28486032 BACKGROUND

• Dicianno BE, Joseph J, Eckstein S, Zigler CK, Quinby EJ, Schmeler MR, Schein RM, Pearlman J, Cooper RA. The future of the provision process for mobility assistive technology: a survey of providers. Disabil Rehabil Assist Technol. 2019 May;14(4):338-345. doi: 10.1080/17483107.2018.1448470. Epub 2018 Mar 20.

  PMID: 29557196 BACKGROUND

• Tang K, Diaz J, Lui O, Proulx L, Galle E, Packham T. Do active assist transfer devices improve transfer safety for patients and caregivers in hospital and community settings? A scoping review. Disabil Rehabil Assist Technol. 2020 Aug;15(6):614-624. doi: 10.1080/17483107.2019.1604822. Epub 2019 Jun 28.

  PMID: 31248300 BACKGROUND

• Greenhalgh M, Landis JM, Brown J, Kulich H, Bass S, Alqahtani S, Deepak N, Cryzter TM, Grindle GG, Koontz AM, Cooper RA. Assessment of Usability and Task Load Demand Using a Robot-Assisted Transfer Device Compared With a Hoyer Advance for Dependent Wheelchair Transfers. Am J Phys Med Rehabil. 2019 Aug;98(8):729-734. doi: 10.1097/PHM.0000000000001176.

  PMID: 31318755 BACKGROUND

• Cohen MH, FAIA F, Nelson GG, Green DA, Borden CM. Patient handling and movement assessments: a white paper. Dallas, TX: The Facility Guidelines Institute. 2010:1-144.

  BACKGROUND

• Darragh AR, Sommerich CM, Lavender SA, Tanner KJ, Vogel K, Campo M. Musculoskeletal Discomfort, Physical Demand, and Caregiving Activities in Informal Caregivers. J Appl Gerontol. 2015 Sep;34(6):734-60. doi: 10.1177/0733464813496464. Epub 2013 Sep 9.

  PMID: 24652897 BACKGROUND

• Owen B, Garg A. Assistive devices for use with patient handling tasks. Advances in Industrial Ergonomics and Safety. 1990;2:585-92.

  BACKGROUND

• Charney W, Hudson A. Back injury among healthcare workers: Causes, solutions, and impacts: CRC Press; 2003

  BACKGROUND

• Joey NCM, Ho Marc WK. Does self-initiated sit-to-stand training with an assistive device regain the independence of sit-to-stand in stroke patient? A single-blinded randomized controlled trial. J Rehabil Assist Technol Eng. 2020 Jan 20;7:2055668319866053. doi: 10.1177/2055668319866053. eCollection 2020 Jan-Dec.

  PMID: 32010452 BACKGROUND

• Koontz AM, Bass SR, Kulich HR. Accessibility facilitators and barriers affecting independent wheelchair transfers in the community. Disabil Rehabil Assist Technol. 2021 Oct;16(7):741-748. doi: 10.1080/17483107.2019.1710771. Epub 2020 Jan 8.

  PMID: 31913066 BACKGROUND

• Toro ML, Koontz AM, Cooper RA. The impact of transfer setup on the performance of independent wheelchair transfers. Hum Factors. 2013 Jun;55(3):567-80. doi: 10.1177/0018720812460549.

  PMID: 23829031 BACKGROUND

• Nelson AL, Groer S, Palacios P, Mitchell D, Sabharwal S, Kirby RL, Gavin-Dreschnack D, Powell-Cope G. Wheelchair-related falls in veterans with spinal cord injury residing in the community: a prospective cohort study. Arch Phys Med Rehabil. 2010 Aug;91(8):1166-73. doi: 10.1016/j.apmr.2010.05.008.

  PMID: 20684896 BACKGROUND

• Peterson EW, Cho CC, Finlayson ML. Fear of falling and associated activity curtailment among middle aged and older adults with multiple sclerosis. Mult Scler. 2007 Nov;13(9):1168-75. doi: 10.1177/1352458507079260. Epub 2007 Sep 19.

  PMID: 17881391 BACKGROUND

• Gavin-Dreschnack D, Nelson A, Fitzgerald S, Harrow J, Sanchez-Anguiano A, Ahmed S, Powell-Cope G. Wheelchair-related falls: current evidence and directions for improved quality care. J Nurs Care Qual. 2005 Apr-Jun;20(2):119-27. doi: 10.1097/00001786-200504000-00006.

  PMID: 15839290 BACKGROUND

• Rice L, Kalron A, Berkowitz SH, Backus D, Sosnoff JJ. Fall prevalence in wheeled mobility device users living with multiple sclerosis. Archives of Physical Medicine and Rehabilitation. 2016;97(10):e40-e1.

  BACKGROUND

• Gagnon D, Koontz A, Mulroy S, Nawoczenski D, Butler-Forslund E, Granstrom A, et al. Biomechanics of sitting pivot transfers among individuals with a spinal cord injury: a review of the current knowledge. Topics in Spinal Cord Injury Rehabilitation. 2009;15(2):33-58.

  BACKGROUND

• King EC, Holliday PJ, Andrews GJ. Care Challenges in the Bathroom: The Views of Professional Care Providers Working in Clients' Homes. J Appl Gerontol. 2018 Apr;37(4):493-515. doi: 10.1177/0733464816649278. Epub 2016 May 29.

  PMID: 27241041 BACKGROUND

• Tzeng HM. A feasibility study of providing folding commode chairs in patient bathrooms to reduce toileting-related falls in an adult acute medical-surgical unit. J Nurs Care Qual. 2011 Jan-Mar;26(1):61-8. doi: 10.1097/NCQ.0b013e3181d94f4d.

  PMID: 22914667 BACKGROUND

• Lam K, Shi Y, Boscardin J, Covinsky KE. Unmet Need for Equipment to Help With Bathing and Toileting Among Older US Adults. JAMA Intern Med. 2021 May 1;181(5):662-670. doi: 10.1001/jamainternmed.2021.0204.

  PMID: 33749707 BACKGROUND

• Nelson A, Lloyd JD, Menzel N, Gross C. Preventing nursing back injuries: redesigning patient handling tasks. AAOHN J. 2003 Mar;51(3):126-34.

  PMID: 12670100 BACKGROUND

• De-Rosende-Celeiro I, Torres G, Seoane-Bouzas M, Avila A. Exploring the use of assistive products to promote functional independence in self-care activities in the bathroom. PLoS One. 2019 Apr 8;14(4):e0215002. doi: 10.1371/journal.pone.0215002. eCollection 2019.

  PMID: 30958846 BACKGROUND

• Barrick AL, Rader J, Hoeffer B, Sloane PD, Biddle S. Bathing without a battle: Person-directed care of individuals with dementia: Springer Publishing Company; 2008.

  BACKGROUND

• Health care workers compensation barometer actuarial analysis. 2018.

  BACKGROUND

• Garg A, Owen BD, Carlson B. An ergonomic evaluation of nursing assistants' job in a nursing home. Ergonomics. 1992 Sep;35(9):979-95. doi: 10.1080/00140139208967377.

  PMID: 1387079 BACKGROUND

• Tsai CY, Boninger ML, Bass SR, Koontz AM. Upper-limb biomechanical analysis of wheelchair transfer techniques in two toilet configurations. Clin Biomech (Bristol). 2018 Jun;55:79-85. doi: 10.1016/j.clinbiomech.2018.04.008. Epub 2018 Apr 12.

  PMID: 29698853 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Nonfatal bathroom injuries among persons aged >/=15 years--United States, 2008. MMWR Morb Mortal Wkly Rep. 2011 Jun 10;60(22):729-33.

  PMID: 21659980 BACKGROUND

• Sung J, Trace Y, Peterson EW, Sosnoff JJ, Rice LA. Falls among full-time wheelchair users with spinal cord injury and multiple sclerosis: a comparison of characteristics of fallers and circumstances of falls. Disabil Rehabil. 2019 Feb;41(4):389-395. doi: 10.1080/09638288.2017.1393111. Epub 2017 Oct 25.

  PMID: 29069956 BACKGROUND

• Blanchet R, Edwards N. A need to improve the assessment of environmental hazards for falls on stairs and in bathrooms: results of a scoping review. BMC Geriatr. 2018 Nov 9;18(1):272. doi: 10.1186/s12877-018-0958-1.

  PMID: 30413144 BACKGROUND

Study Officials

• Alicia M Koontz, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikitha Deepak, MS

CONTACT

412-822-3669; NID51@pitt.edu

Edward J McClain, MA

CONTACT

tjm290@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor - School of Health and Rehabilitation Science

Model Details: This is a single group longitudinal intervention study, conducted using descriptive survey design and data logs by the user.

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)