Skip to main content
Clinical Trials/NCT06576947
NCT06576947
Not yet recruiting
Not Applicable

Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis: A Randomized Clinical Trial

Universidad de Almeria0 sites45 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Universidad de Almeria
Enrollment
45
Primary Endpoint
Pelvic floor strength
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of the current randomized clinical trial was to compare the effectiveness of virtual reality versus posterior tibial nerve stimulation on the improvement of pelvic floor dysfunctions in women with multiple sclerosis.

Detailed Description

* Design: Randomized Clinical Trial. Objective: to determine the effects of virtual reality versus posterior tibial nerve stimulation and muscle activation exercises on the improvement of pelvic floor dysfunctions in women with multiple sclerosis. * Methods and Measures: forty five women will be randomly assigned to one of three groups. * Intervention: For 8-week, the group 1 will undergo treatment with virtual reality (2/week), the group 2 will receive posterior tibial nerve stimulation (2/week) and the group 3 will receive muscle activation exercises of the pelvic floor. * Main Outcome Measures: assessment of pelvic floor muscles function (strength and muscle tone), urodynamic studies, and validated questionnaires data will be collected at baseline, and 1 week after the last therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guadalupe Molina Torres

Senior Lecturer

Universidad de Almeria

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of multiple sclerosis
  • Presence of pelvic floor dysfunction
  • Acceptance participation
  • Not undergoing another physical therapy treatment

Exclusion Criteria

  • Non-acceptance of participation
  • Mental illness
  • Interruption of adherence to protocolized treatment sessions
  • Indication of surgical treatment in the pelvic floor

Outcomes

Primary Outcomes

Pelvic floor strength

Time Frame: At baseline, immediately after the intervention, and 4 weeks] [Safety Issue: No] It is a device for measuring the strength of the pelvic floor, to which a speculum is adapted. measure force in newtons

Pelvic floor strength using a perineometer, a device for measuring the strength of the pelvic floor, to which a speculum is adapted. measure force in newtons

Secondary Outcomes

  • Multiple Sclerosis Quality of Life-54 (MSQOL-54):(At baseline, immediately after the intervention, and 4 weeks)
  • SF12(At baseline, immediately after the intervention, and 4 weeks)
  • Australian pelvic floor questionnaire:(At baseline, immediately after the intervention, and 4 weeks)
  • Euroqol(At baseline, immediately after the intervention, and 4 weeks)

Similar Trials