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

NCT06162845 | Completed

• 1 other identifier: UCentralArkansas
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Floor Muscle Weakness

Keywords

Smartphone Applications; Home exercise program; Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Experimental arm recieving free smartohone-based pelvic floor muscle exercise application

EXPERIMENTAL

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

Control arm recieving paper-based home exercise program

ACTIVE COMPARATOR

Paper-based home exercise program for performing pelvic floor muscle exercises.

Behavioral: Paper-based home exercise program for pelvic floor muscle exercise

Interventions

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.

Experimental arm recieving free smartohone-based pelvic floor muscle exercise application

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.

Control arm recieving paper-based home exercise program

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Assigned female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• University of Central Arkansas: lead

Study Sites (1)

Advanced Physical Therapy

Little Rock, Arkansas, 72210, United States

Location

Study Officials

• Sarah M Walker, DPT

  University of Central Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to their group allocation and were not aware that another treatment existed until debriefing and unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student enrolled in PhD in Physical Therapy program

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 8, 2023
• Study Start: May 11, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Sarah Walker at sarahmwalker86@gmail.com

Locations

US (1)