Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03917615
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Haifa

Brief Summary:
The study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.

Condition or disease Intervention/treatment Phase
Pelvic Floor Muscle Weakness Other: pelvic floor contraction Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups according to the year of physiotherapy school.
Masking: Single (Participant)
Masking Description: Participants will not know the aim of study
Primary Purpose: Screening
Official Title: Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Women's Health

Arm Intervention/treatment
Experimental: after "women health" course
The participants will be instructed to contract the pelvic floor muscle
Other: pelvic floor contraction
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
Other: pelvic floor contraction
Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function




Primary Outcome Measures :
  1. direction of urinary bladder displacement during contraction [ Time Frame: baseline ]
    upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

  2. urinary bladder displacement in millimeters [ Time Frame: baseline ]
    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool


Secondary Outcome Measures :
  1. pelvic floor muscles endurance of contraction in seconds [ Time Frame: baseline ]
    time of muscle contraction will be measured during the last contraction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917615


Contacts
Layout table for location contacts
Contact: Gali Dar, PhD 972-50-5662054 galidar@yahoo.com

Locations
Layout table for location information
Israel
Haifa University, Department of PHysical Therapy Recruiting
Haifa, Israel
Contact: Gali Dar, PhD    972-50-5662054    galidar@yahoo.com   
Sponsors and Collaborators
University of Haifa
Investigators
Layout table for investigator information
Study Director: Gali Dar, PhD University of Haifa

Publications of Results:
Layout table for additonal information
Responsible Party: University of Haifa
ClinicalTrials.gov Identifier: NCT03917615     History of Changes
Other Study ID Numbers: 123/19
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results
Supporting Materials: Study Protocol
Time Frame: one year

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Haifa:
pelvic diaphragm, Physiotherapy students, education

Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms