Multiple Sclerosis
Conditions
Keywords
virtual reality, multiple sclerosis, pelvic floor, randomized controlled trial
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.
Interventions
OTHERVirtual reality
Participants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week
OTHERNeuromodulation of the tibialis posterior nerve
Participants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes
OTHERPelvic floor muscle training
Participants receive pelvic floor muscle training 5 times a day for 9 weeks
Sponsors
Universidad de Almeria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single Blind (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor strength | 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
| Measure | Time frame | Description |
|---|---|---|
| Australian pelvic floor questionnaire: | At baseline, immediately after the intervention, and 4 weeks | 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 |
| Multiple Sclerosis Quality of Life-54 (MSQOL-54): | At baseline, immediately after the intervention, and 4 weeks | 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). |
| Euroqol | At baseline, immediately after the intervention, and 4 weeks | 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. |
| SF12 | At baseline, immediately after the intervention, and 4 weeks | 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. |
Outcome results
None listed