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

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).

Study Overview

• Status: Unknown
• Conditions: Pelvic Floor Dyssynergia

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

healthy women, students of the University of Applied Sciences Health

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
20 healthy women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMG	EMG will measure the contraction of the plevic floor	one year

Collaborators and Investigators

• Sponsor: Moser, Helene
• Investigators: Study Chair: Lorenz Radlinger, PhD, Berner Fachhochschule Gesundheit, Bern, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Estimate): May 3, 2012
• Last Update Submitted That Met QC Criteria: May 2, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: ultrasonography; pelvic floor
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Ataxia
• Other Study ID Numbers: MScPTHM