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Completed

NCT Number: NCT06162845

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 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.

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Key information

Conditions

Pelvic Floor Muscle Weakness

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Physical Therapy

Little Rock, Arkansas, 72210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-85 years old
  • Referred to outpatient pelvic floor physical therapy for treatment of pelvic floor weakness
  • Generation 5 or later iPhone, Android, or Smart Device
  • Must be willing to receive Push Notification reminders from the application
  • Must have free space on device to download and install app
  • Must have access to the Google Play store or to iOS Apple App Store

Exclusion criteria

  • ● Not Meeting Inclusion Criteria
  • Pelvic Organ Prolapse Surgery with complications
  • Neurodegenerative Disease
  • History of TBI or CVA with resulting impairment in long- or short-term memory
  • Denervation injury to the pelvic floor
  • Spinal cord injury
  • Pelvic Pain Condition
  • Incapable of Completing Outcomes Questionnaire without caregiver support
  • Unable to speak and read English
  • Current Pregnancy
  • Less than 6 weeks postpartum
  • Researcher judgement

Treatment and study plan

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

Use of a smartphone-based home exercise application for pelvic floor muscle exercises with visual and auditory feedback for 10 repetitions of pelvic floor contraction endurance holds and 10 repetitions of pelvic floor quick contractions performed three times per day.

Paper-based home exercise program for pelvic floor muscle exercise

Behavioral

Written instructions on a piece of paper for 10 repetitions of pelvic floor contraction endurance holds and 10 repetitions of pelvic floor quick contractions performed three times per day.

Primary outcomes

  1. Pelvic Floor Distress Inventory short-form 20 (PFDI-20)

    Time frame: From date of randomization through study completion, an average of 3 months.

    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.

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Sponsors and collaborators

Lead sponsor

University of Central Arkansas

Other

Registry information

Official study title

Smart Soulitions: A Single-blind Randomized Controlled Trial Comparing Smartphone-based Home Exercise to the Paper-based Standard of Care on Pelvic Floor Muscle Weakness Outcomes and Home Exercise Adherence.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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