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NCT06162845 · ClinicalTrials.gov registry record · NA
Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT
A NA study, sponsored by University of Central Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT06162845: Completed NA study, sponsored by University of Central Arkansas.
NCT06162845 is a NA study that has completed, run by University of Central Arkansas. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06162845, a NA study, has completed, sponsored by University of Central Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The goal of this randomized clinical trial is to investigate the impact of a smartphone-based application on patient-reported outcomes for patients with pelvic floor muscle weakness, and the relationship of patient adherence to outcomes in pelvic floor physical therapy compared to the paper-based standard of care. An additional aim is the exploration and development of two patient-reported questionnaires to enhance understanding of exercise adherence in outpatient pelvic floor physical therapy and smartphone application self-efficacy. These goals will serve to improve practice recommendations for home exercise prescriptions in this patient population. Participants will be asked to complete 6 patient-reported outcome measures after they complete four, 60-minute long physical therapy treatment sessions conducted one time per week according to the current standard of care for pelvic floor physical therapy. The experimental group will be given a free pelvic floor muscle exercise application while the control group will be provided with the paper-based standard of care for their home exercise program.
Primary Outcome
Patient-reported health-related quality of life outcome measures that are widely used for assessment of pelvic floor dysfunction. The minimum score is 0, and the maximum score is 300. HIgher scores indicate higher levels of dysfunction and mean a worse outcome, lower levels indicate less dysfunction and a better outcome.
Interventions
- BEHAVIORAL A smartphone based application free to download from the google play and iphone store to provide auditory and visual cues and counting for number of perscribed pelvic floor muscle contractions
- BEHAVIORAL Paper-based home exercise program for pelvic floor muscle exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-05-11 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
What the finished NCT06162845 record still lists
NCT06162845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which A smartphone based application free to download from the google play and iphone store to provide auditory and visual cues and counting for number of perscribed pelvic floor muscle contractions is the first listed.
NCT06162845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06162845 about?
NCT06162845 is a clinical study titled "Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT". The goal of this randomized clinical trial is to investigate the impact of a smartphone-based application on patient-reported outcomes for patients with pelvic floor muscle weakness, and the relationship of patient adherence to outcomes in pelvic floor physical therapy compared to the paper-based st...
What is the current status of trial NCT06162845?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2022-05-11. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT06162845?
The interventions under investigation include: A smartphone based application free to download from the google play and iphone store to provide auditory and visual cues and counting for number of perscribed pelvic floor muscle contractions (BEHAVIORAL), Paper-based home exercise program for pelvic floor muscle exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT06162845?
This trial is sponsored by University of Central Arkansas, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06162845's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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