Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidad de Almeria
- Enrollment
- 45
- Primary Endpoint
- Pelvic floor strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Single Blind (Subject)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Virtual reality therapy
It will ve placement of virtual reality glasses that will indicate to the patient when to contract the pelvic floor.
Intervention: Virtual reality (Other)
Neuromodulation of the tibialis posterior
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.
Intervention: Neuromodulation of the tibialis posterior nerve (Other)
Pelvic Floor Muscle Training
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.
Intervention: Pelvic floor muscle training (Other)
Outcomes
Primary Outcomes
Pelvic floor strength
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
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 Outcomes
- Multiple Sclerosis Quality of Life-54 (MSQOL-54):(At baseline, immediately after the intervention, and 4 weeks)
- SF12(At baseline, immediately after the intervention, and 4 weeks)
- Australian pelvic floor questionnaire:(At baseline, immediately after the intervention, and 4 weeks)
- Euroqol(At baseline, immediately after the intervention, and 4 weeks)
Investigators
Guadalupe Molina Torres
Senior Lecturer
Universidad de Almeria