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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Pelvic Floor Muscle Weakness

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm recieving free smartohone-based pelvic floor muscle exercise application<br>Smartphone-based home exercise program for performing pelvic floor muscle exercises | 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<br>* 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.<br>|
| Active Comparator: Control arm recieving paper-based home exercise program<br>Paper-based home exercise program for performing pelvic floor muscle exercises. | Behavioral: Paper-based home exercise program for pelvic floor muscle exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Distress Inventory short-form 20 (PFDI-20) | 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. | From date of randomization through study completion, an average of 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone Applications, Home exercise program, Adherence