Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversidad de Almeria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of multiple sclerosis

Presence of pelvic floor dysfunction

Acceptance participation

Not undergoing another physical therapy treatment

Disqualifiers

Non-acceptance of participation

Mental illness

Interruption of adherence to protocolized treatment sessions

Indication of surgical treatment in the pelvic floor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality

    Other intervention

    Participants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week

  • Neuromodulation of the tibialis posterior nerve

    Other intervention

    Participants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes

  • Pelvic floor muscle training

    Other intervention

    Participants receive pelvic floor muscle training 5 times a day for 9 weeks

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Virtual reality therapyExperimental treatment 1 intervention
Group B: Neuromodulation of the tibialis posteriorExperimental treatment 1 intervention
Group C: Pelvic Floor Muscle TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pelvic floor strength

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

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

Secondary outcomes

1

Australian pelvic floor questionnaire:

The APFQ is an instrument consisting of 42 questions in 4 domains (bladder, bowel, and sexual function and pelvic organ prolapse). relevant questions and multiplied by 10; thus, the scores range from 0 to 10 for each domain, giving a maximum total score of 40

Time frame
At baseline, immediately after the intervention, and 4 weeks
2

Multiple Sclerosis Quality of Life-54 (MSQOL-54):

The instrument has Likert scales and multiple-choice items. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). The instrument has Likert scales and multiple-choice items. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).

Time frame
At baseline, immediately after the intervention, and 4 weeks
3

Euroqol

It is a generic and standardized instrument developed to describe and assess health-related quality of life. The descriptive system contains five dimensions of health (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, some problems or moderate problems, and severe problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to their health status in each of the dimensions, referring to the same day they completed the questionnaire. In each dimension of the EQ-5D, severity levels are coded as 1 if the response option is "I have no problems"; with a 2 if the response option is "some or moderate problems"; and with a 3 if the answer option is "many problems." The higher score meaning a worse result.

Time frame
At baseline, immediately after the intervention, and 4 weeks
4

SF12

This questionnaire contains 12 items that assess 8 aspects of HRQoL: physical dimension, mental dimension, physical function, physical role, bodily pain, general health, vitality, emotional role, social function, and mental health. The SF-12 v2 response options form Likert-type scales that evaluate intensity or frequency. The number of response options ranges between three and six, depending on the item, and each question receives a value that is subsequently transformed into a scale from 0 to 100.

Time frame
At baseline, immediately after the intervention, and 4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: