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

Официальное название

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

Обзор

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.

Подробное описание

* 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.

Вмешательства

• Другое Virtual reality
  Participants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week
• Другое Neuromodulation of the tibialis posterior nerve
  Participants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes
• Другое Pelvic floor muscle training
  Participants receive pelvic floor muscle training 5 times a day for 9 weeks

Первичные конечные точки

• Pelvic floor strength [Срок оценки: 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]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06576947 · UALBIO2024/015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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