Clinical trial NCT06162845: Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Keywords: Smartphone Applications
Home exercise program
Adherence
Lead sponsor: University of Central Arkansas
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pelvic Floor Distress Inventory short-form 20 (PFDI-20)
timeFrame: From date of randomization through study completion, an average of 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Advanced Physical Therapy
state: Arkansas
Study officials:
affiliation: University of Central Arkansas
name: Sarah M Walker, DPT
role: PRINCIPAL_INVESTIGATOR
References: