PPAL for Age-Related Issues

Overseen By Edward J McClain, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alicia Koontz

Disqualifiers: Ventilator users, Recent medical events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the PPAL, a special toilet chair that assists people in moving on and off the toilet with less caregiver support. The goal is to evaluate the device's effectiveness in real homes and its impact on daily life for both users and their helpers. The trial suits individuals who struggle with toilet transfers and live in a home or assisted living setting that can accommodate the device. Participants and their caregivers will provide feedback on their experience using the PPAL over six weeks. This information will help developers enhance the device for future users. As an unphased trial, this study offers participants the opportunity to contribute to the development of a potentially life-enhancing device.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a toileting device, so it's unlikely that medication changes are required.

What prior data suggests that the PPAL assisted toileting device is safe?

Research shows that the PPAL device, designed to assist people in moving to and from a toilet, carries very low risks. The primary concerns include minor injuries such as scrapes or bruises and the possibility of falling while users acclimate to the device. These risks are expected to be rare. The study team will demonstrate proper use of the device and monitor participants to help prevent these issues. Additionally, the device is being evaluated to ensure the privacy of personal information. Overall, with careful use and monitoring, the device appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for age-related issues, which often focus on managing symptoms with medications or lifestyle changes, PPAL is unique because it potentially targets the underlying mechanisms of aging. Researchers are particularly excited about PPAL because it may offer a novel approach by enhancing cellular repair and regeneration. This could lead to more comprehensive and longer-lasting improvements in age-related conditions, setting it apart from current options that mainly address surface-level symptoms.

What evidence suggests that the PPAL device is effective for age-related issues?

Research on the PPAL device remains in the early stages, so solid data on its effectiveness is not yet available. In this trial, participants will use the PPAL, designed to assist individuals who need help moving to and from the bathroom. The device is a powered chair that can change height and includes boards to aid in transfers. By enabling users to assist with their own transfers, it may reduce the risk of injuries for both users and caregivers. The PPAL aims to make bathroom visits easier and safer. Early indications suggest that such a device could enhance the quality of life for individuals with mobility issues related to aging. ^{2 6 7 8 9}

Who Is on the Research Team?

Alicia M Koontz, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals with age-related mobility issues who need assistance transferring to and from a toilet. Participants must be able to have a home visit, use the PPAL device for toileting, and participate in interviews. Caregivers are also involved.

Inclusion Criteria

Weighs 300 pounds or less and is able to fit within the dimensions of the PPAL

Resides in either a home, independent living residence, assisted living or extended care residence

I struggle to use the toilet without help.

Exclusion Criteria

Ventilator users

I cannot physically help with moving or handling the PPAL due to my own limitations.

I have no surgeries planned in the next 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 home visit

Treatment

Participants use the PPAL device at home to assist with toileting transfers

6 weeks

1 initial setup visit, 1 final visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 follow-up interview

What Are the Treatments Tested in This Trial?

Interventions

• PPAL

Trial Overview The study tests the PPAL, an adjustable commode chair designed to aid transfers with minimal caregiver help. Over six weeks at home, its impact on safety and ease of transfer will be evaluated through observations and interviews.

How Is the Trial Designed?

Group I: PPAL user Experimental Treatment 1 Intervention

This is the experimental group. These participants will trial the PPAL.

Who Is Running the Clinical Trial?

Alicia Koontz

Lead Sponsor

Trials

2

Recruited

30+

QUA Inc.

Collaborator

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. usf.edu usf.edu/cbcs/aging-studies/research/

Research - School of Aging Studies Studies examine the effects of age-related conditions on quality of life, including Alzheimer's disease, cancer, obesity, osteoarthritis, and terminal illness.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9351724/

Age-related Impairments on the Touchscreen Paired ... This study found age-related deficits in PAL task acquisition in male rats. Furthermore, trial-by-trail analyses and testing rats on a novel interference ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S019745802100302X

Age-related impairments on the touchscreen paired ... Aged male rats are impaired in PAL task acquisition relative to young. Response-driven behavior translates from 3-D mazes to 2-D touchscreens.

4. researchgate.net researchgate.net/publication/355071031_Age-related_Impairments_on_the_Touchscreen_Paired_Associates_Learning_PAL_Task_in_Male_Rats

Age-related Impairments on the Touchscreen Paired ... This study found age-related deficits in PAL task acquisition in male rats. Furthermore, trial-by-trail analyses and testing rats on a novel interference ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6611108/

Interventions to Reduce Ageism Against Older Adults Research has shown that ageism directed toward older adults has a negative impact on their health, well-being, and quality of health care received. The scope of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5732407/

Age-Related Diseases and Clinical and Public Health ... This paper reviews relevant changes of normal aging, diseases, and syndromes common in people over age 85, cognitive and psychological changes, social and ...

7. odphp.health.gov odphp.health.gov/our-work/national-health-initiatives/healthy-aging/social-determinants-health-and-older-adults

Social Determinants of Health and Older Adults Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age

8. ncoa.org ncoa.org/article/get-the-facts-on-falls-prevention/

Get the Facts on Falls Prevention Falls are the leading cause of fatal and non-fatal injuries among older adults.2; In 2021, falls caused 38,000 deaths among those age 65+, and ...

9. ihpi.umich.edu ihpi.umich.edu/national-poll-healthy-aging/reports-and-resources/their-minds-older-adults-top-health-related

On Their Minds: Older Adults' Top Health-Related Concerns From health care costs to social isolation to neighborhood safety, the poll asked people age 50 and over about their level of concern about ...