Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

Pelvic Floor Dyssynergia Clinical Trial

Official title:

Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01590927
• Other study ID #: MScPTHM
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2012
• Last updated: May 2, 2012
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Moser, Helene
• Contact: Helene Moser, Msc in study
• Phone: 0041787752118
• Email: helmos69[@]gmail.com
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Pelvic Floor Dyssynergia

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Moser, Helene

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Epub 2006 Feb 16. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR	the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR	one year	No
Secondary	EMG	EMG will measure the contraction of the plevic floor	one year	No