Clinical trial NCT01590927: Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study
Official title: Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Dyssynergia
Keywords: pelvic floor
ultrasonography
Lead sponsor: Moser, Helene
Sponsor class: INDIV
First posted: 2012-05-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women, students of the University of Applied Sciences Health

Brief summary: Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, \& Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be used in measuring functional movements. In this Master thesis the hypothesis is to show a good reliability by trampoline jumping (physical activity).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR
timeFrame: one year
Secondary outcomes:
measure: EMG
timeFrame: one year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Berner Fachhochschule Gesundheit, Bern, Switzerland
name: Lorenz Radlinger, PhD
role: STUDY_CHAIR
References:
citation: Peng Q, Jones RC, Constantinou CE. 2D Ultrasound image processing in identifying responses of urogenital structures to pelvic floor muscle activity. Ann Biomed Eng. 2006 Mar;34(3):477-93. doi: 10.1007/s10439-005-9059-3. Epub 2006 Feb 16.
citation: Sherburn M, Murphy CA, Carroll S, Allen TJ, Galea MP. Investigation of transabdominal real-time ultrasound to visualise the muscles of the pelvic floor. Aust J Physiother. 2005;51(3):167-70. doi: 10.1016/s0004-9514(05)70023-4.