Clinical trial NCT06576947: Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis
Official title: Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: virtual reality
multiple sclerosis
pelvic floor
randomized controlled trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pelvic floor strength
timeFrame: 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
Secondary outcomes:
measure: Australian pelvic floor questionnaire:
timeFrame: At baseline, immediately after the intervention, and 4 weeks
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54):
timeFrame: At baseline, immediately after the intervention, and 4 weeks
measure: Euroqol
timeFrame: At baseline, immediately after the intervention, and 4 weeks
measure: SF12
timeFrame: At baseline, immediately after the intervention, and 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Almeria
name: Guadalupe Molina Torres
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Almeria
name: Jacobo Ángel Rubio-Arias
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Almeria
name: Marta María Córdoba Peláez
role: PRINCIPAL_INVESTIGATOR
References: