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

Pelvic Floor Muscle Weakness Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06162845
• Other study ID #: UCentralArkansas
• Status: Completed
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: University of Central Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Advanced Physical Therapy	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.