- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03917615
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physiotherapy students during their studying in the physiotherapy Bachelor degree program will be examined. Students will be divided into 2 groups according to their year of studying (if they already studied "women health course or not implying 4th year students compared with 1-3 year level students). Each participant will be asked to contract the pelvic floor muscles.
The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. Upward movement of the bladder during contraction will be marked as correct contraction. An on screen caliper and measurement tool will be used to measure bladder amount of bladder displacement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Haifa University, Department of PHysical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy students
- willing to participate in the study
Exclusion Criteria:
- has been treated before for pelvic floor rehabilitation
- active urinary tract infection
- pregnancy
- previous abdominal surgeries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: after "women health" course
The participants will be instructed to contract the pelvic floor muscle
|
Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
|
ACTIVE_COMPARATOR: before "women health" course
The participants will be instructed to contract the pelvic floor muscle
|
Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
direction of urinary bladder displacement during contraction
Time Frame: baseline
|
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
|
baseline
|
urinary bladder displacement in millimeters
Time Frame: baseline
|
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pelvic floor muscles endurance of contraction in seconds
Time Frame: baseline
|
time of muscle contraction will be measured during the last contraction
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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