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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality therapy | Experimental | It will ve placement of virtual reality glasses that will indicate to the patient when to contract the pelvic floor. |
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| Neuromodulation of the tibialis posterior | Experimental | Is placed a external electrode 5 centimeters (cm) above the medial malleolus and 1 cm behind of the tibia and another electrode on the medial aspect of the foot, below the malleolus. The kind of electric current used will be rectangular, biphasic, with a pulse duration of 220 Ps and a frequency of 10 Hz. To avoid habituation to the current, a phase of 20 s stimulation with a 4 s rest phase. The intensity of the current will be inframotor, just below the contraction threshold of the flexor digitorum muscle brevis. |
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| Pelvic Floor Muscle Training | Experimental | Patients will perform Pelvic Floor Muscle Training. Before performing this treatment at home, a session will be held with an expert physiotherapist in pelvic floor who will explain its implementation to the participants of this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Other | Participants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline, immediately after the intervention, and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guadalupe Molina Torres | Universidad de Almeria | Principal Investigator |
| Jacobo Ángel Rubio-Arias | Universidad de Almeria | Principal Investigator |
| Marta María Córdoba Peláez | Universidad de Almeria | Principal Investigator |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Single Blind (Subject)
| Neuromodulation of the tibialis posterior nerve | Other | Participants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes |
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| Pelvic floor muscle training | Other | Participants receive pelvic floor muscle training 5 times a day for 9 weeks |
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| 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). | At baseline, immediately after the intervention, and 4 weeks |
| 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. | At baseline, immediately after the intervention, and 4 weeks |
| 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. | At baseline, immediately after the intervention, and 4 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |