Pelvic Floor Muscle WeaknessNCT06162845
Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT
A study testing 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 people with Pelvic Floor Muscle Weakness, run by University of Central Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Weakness
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ● 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Advanced Physical Therapy
Little Rock, Arkansas, 72210
About this study
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.
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.
Read more
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.
- Conditions
- Pelvic Floor Muscle Weakness
- Being tested
- 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 pelvic floor muscle exercise
- Keywords
- Smartphone Applications, Home exercise program, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 contractionsBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm recieving free smartohone-based pelvic floor muscle exercise application | Experimental | Smartphone-based home exercise program for performing pelvic floor muscle exercises Receives: 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 | Paper-based home exercise program for performing pelvic floor muscle exercises. Receives: Behavioral: Paper-based home exercise program for pelvic floor muscle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start11 May 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Walker, University of Central Arkansas
- Investigators
- Sarah M Walker, DPT, Principal investigator, University of Central Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162845
- Sponsor's protocol ID
- UCentralArkansas
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06162845
- Acronym / sponsor ID
- UCentralArkansas
- Conditions
- Pelvic Floor Muscle Weakness
- Keywords
- Smartphone Applications, Home exercise program, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Central ArkansasUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm recieving free smartohone-based pelvic floor muscle exercise application | Experimental | 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 contractionsSmartphone-based home exercise program for performing pelvic floor muscle exercises |
| Control arm recieving paper-based home exercise program | Active comparator | Behavioral: Paper-based home exercise program for pelvic floor muscle exercisePaper-based home exercise program for performing pelvic floor muscle exercises. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-85 years old
Key exclusion criteria (12 listed)
- ● Not Meeting Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 contractionsUse 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. | Behavioural | Experimental arm recieving free smartohone-based pelvic floor muscle exercise application |
| Paper-based home exercise program for pelvic floor muscle exerciseWritten 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. | Behavioural | Control arm recieving paper-based home exercise program |
Primary outcome
Pelvic Floor Distress Inventory short-form 20 (PFDI-20)
Time frame: From date of randomization through study completion, an average of 3 months.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: 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.
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Active, not recruiting
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
Urinary Dysfunction, Vaginal Prolapse
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M Walker, DPT principal investigator
University of Central Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Pelvic Floor Muscle Weakness, run by University of Central Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Distress Inventory short-form 20 (PFDI-20) (time frame: From date of randomization through study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.