Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162845
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-11-09
Brief Title:
Single-blind RCT Comparing Smartphone vs Paper-based HEP in Pelvic Floor PT
Sponsor:
University of Central Arkansas
Organization:
University of Central Arkansas
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None