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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Muscle Weakness
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72210
      • Advanced Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Central Arkansas
• Investigators: Principal Investigator: Sarah M Walker, DPT, University of Central Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Home exercise program; Smartphone Applications
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis; Asthenia
• Other Study ID Numbers: UCentralArkansas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in pelvic floor muscle weakness, home exercise adherence, and smartphone application use for home exercise adherence. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No