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PPAL评估

2026年11月2日 更新者：Alicia Koontz

PPAL床边便桶的开发与评估：实现安全独立的如厕转移

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

16

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Nikitha Deepak, MS
  • 电话号码：412-822-3669
  • 邮箱：NID51@pitt.edu

研究联系人备份

学习地点

  • 美国
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15206
        • 招聘中
        • University of Pittsburgh: Human Engineering Research Laboratories
        • 首席研究员：
          • Alicia Koontz, PhD
        • 接触：
          • Nikitha Deepak, MS
          • 电话号码：412-407-2047
          • 邮箱：NID51@pitt.edu
        • 接触：
          • Edward J McClain, MA
          • 电话号码：412-407-2047
          • 邮箱：tjm290@pitt.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：PPAL 用户
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in fall efficacy with connection to toileting
大体时间：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.
Change from pre to post 6 week trial

次要结果测量

结果测量
措施说明
大体时间
Change in GG Self-Care score for Toilet Transfer
大体时间：Change from pre to post 6 week trial

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.
Change from pre to post 6 week trial
System Usability Scale (SUS)
大体时间：At the end of the 6 week trial

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).
At the end of the 6 week trial

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alicia Koontz

合作者

National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
QUA Inc.

调查人员

  • 首席研究员：Alicia M Koontz, PhD、University of Pittsburgh

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月20日

初级完成 (估计的)

2026年11月20日

研究完成 (估计的)

2026年11月20日

研究注册日期

首次提交

2025年10月24日

首先提交符合 QC 标准的

2025年10月24日

首次发布 (实际的)

2025年10月28日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • STUDY25100178
  • 5R44NR019516-03 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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