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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06162845
Other study ID # UCentralArkansas
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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