An interventional study of 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 and Paper-based home exercise program for pelvic floor muscle exercise in Pelvic Floor Muscle Weakness, sponsored by University of Central Arkansas. Completed at 1 site in United States. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by University of Central Arkansas · Not applicable, Interventional, and Treatment
Among 145 studies in Muscle Weakness with a site in United States — 21 open to participants now, 27 under way, none of them phase 3. Muscle Weakness · United States.
Among the 145 studies in Muscle Weakness with a site in United States, this one is the 54th largest by enrollment of the 113 interventional ones, is one of 12 that started in 2022, is one of 81 with no phase, and was the 127th registered.
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's enrollment of 33 is below the median of 44 across 362 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →21 of the 145 studies in Muscle Weakness with a site in United States are open now, in 11 countries. Each count lists the studies.
Of the 54 Muscle Weakness studies recruiting now, 24 (44%) set no upper age limit and 22 (41%) stop at 75 or younger; 6 take children under 18; 19 take healthy volunteers.
This study: 18 Years to 85 Years · female · no healthy volunteers.
The full table on the hub →145 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 12 started in 2022.
Median enrollment 32 across the 113 interventional studies, 73 across the 32 observational. Of the 105 that completed or were terminated, 28 (27%) have results posted.
22 of 145 have an industry lead sponsor. The 10 most frequent:
University of Central Arkansas is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
University of Central Arkansas has 1 study filed under Muscle Weakness — fewer than ten, so there is no comparison to draw.
11 of the studies in Muscle Weakness with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05725928The Cleveland ClinicAssisted Ambulation to Improve Health Outcomes for Older Medical Inpatients | 2026-11-30 |
| NCT05877846University of North Carolina, Chapel HillPrecision Medicine and Physical Function | 2026-12-01 |
| NCT07009717University of FloridaRelationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) | 2026-12-31 |
| NCT06441422Medical College of WisconsinBlood Flow Restriction Training for People With Disabilities | 2026-12-31 |
| NCT00390104Boston Children's HospitalMolecular Analysis of Patients With Neuromuscular Disease | 2026-12-31 |
Among the 145 studies in Muscle Weakness with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
18-85 years old
Exclusion Criteria:
● Not Meeting Inclusion Criteria
Smartphone-based home exercise program for performing pelvic floor muscle exercises
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
Paper-based home exercise program for performing pelvic floor muscle exercises.
Behavioral: Paper-based home exercise program for pelvic floor muscle exercise
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.
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.
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.
Time frame: From date of randomization through study completion, an average of 3 months.
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in pelvic floor muscle weakness, home exercise adherence, and smartphone application use for home exercise adherence. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Sarah Walker at sarahmwalker86@gmail.com
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Jul 2023, 14 months.
Of 200 non-industry interventional studies with no phase under Muscle Weakness, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 14 months is above that.
Counting every sponsor, half of 212 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Central Arkansas