Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study
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ClinicalTrials.gov Identifier: NCT01590927 |
Recruitment Status
: Unknown
Verified May 2012 by Helene Moser, Moser, Helene.
Recruitment status was: Not yet recruiting
First Posted
: May 3, 2012
Last Update Posted
: May 3, 2012
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Condition or disease |
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Pelvic Floor Dyssynergia |
There will be two measurements. One measurement of MVIC and quick flicks will be done in a standing and supine position with 3 repetitions. The TrakSTARTM, Ultrasound, surface EMG and Accelerometer will measure the PFM movements and activation simultaneously. The Ultrasound is measured from one tester (to guaranty a high intratester reliability) (Sherburn et al., 2005).
TrakSTARTM, surface EMG and Accelerometer will measure 3 Trampoline jumps. The measurements will be done once during one hour. The women will insert the vaginal probe by themselves and stay dressed during the measurement procedure. The measurements will be done in a standardized way. All the arrangements are made to ensure the hygiene requirements.
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Official Title: | Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | May 2013 |
Group/Cohort |
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20 healthy women |
- the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR [ Time Frame: one year ]the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR
- EMG [ Time Frame: one year ]EMG will measure the contraction of the plevic floor

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- women
- aged between 18 and 35 years
- anamnestically healthy
- nulliparous and
- a BMI between 18 and 30
Exclusion Criteria:
- latex and nickel allergy
- anamnestically current pregnancy
- menstruation
- urogenital operations
- anal operations
- vaginal infections

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): NCT01590927
Contact: Helene Moser, Msc in study | 0041787752118 | helmos69@gmail.com |
Switzerland | |
Inselspital | Not yet recruiting |
Bern, Switzerland, 3010 | |
Contact: Helene Moser, MSc in study 0041787752118 helmos69@gmail.com |
Study Chair: | Lorenz Radlinger, PhD | Berner Fachhochschule Gesundheit, Bern, Switzerland |
Publications:
Responsible Party: | Helene Moser, Physiotherapist, Moser, Helene |
ClinicalTrials.gov Identifier: | NCT01590927 History of Changes |
Other Study ID Numbers: |
MScPTHM |
First Posted: | May 3, 2012 Key Record Dates |
Last Update Posted: | May 3, 2012 |
Last Verified: | May 2012 |
Keywords provided by Helene Moser, Moser, Helene:
pelvic floor ultrasonography |