Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT
NCT ID: NCT06162845
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2022-05-11
2023-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental arm recieving free smartohone-based pelvic floor muscle exercise application
Smartphone-based home exercise program for performing pelvic floor muscle exercises
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
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.
Control arm recieving paper-based home exercise program
Paper-based home exercise program for performing pelvic floor muscle exercises.
Paper-based home exercise program for pelvic floor muscle exercise
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.
Interventions
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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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
FEMALE
No
Sponsors
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University of Central Arkansas
OTHER
Responsible Party
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Sarah Walker
Graduate Student enrolled in PhD in Physical Therapy program
Principal Investigators
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Sarah M Walker, DPT
Role: PRINCIPAL_INVESTIGATOR
University of Central Arkansas
Locations
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Advanced Physical Therapy
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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UCentralArkansas
Identifier Type: -
Identifier Source: org_study_id