Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT

Completed · Not applicable

Conditions studied: Pelvic Floor Muscle Weakness

In brief

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.

Key facts

Study ID

NCT06162845

Run by

University of Central Arkansas

People needed

33

Starts

2022-05-11

Expected to finish

2023-07-31

Last updated by the study team

2023-12-08

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• ● 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

Where it is running

• Advanced Physical Therapy — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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