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

University of Central Arkansas

Status: Completed

Conditions: Pelvic Floor Muscle Weakness

Treatments: 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

Funder types: Other

Identifiers

NCT06162845

UCentralArkansas

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

33 participants in 2 patient groups

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

Experimental group

Description:

Smartphone-based home exercise program for performing pelvic floor muscle exercises

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

Control arm recieving paper-based home exercise program

Active Comparator group

Description:

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

Treatment:

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