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

NCT ID: NCT06576947

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual reality therapy

It will ve placement of virtual reality glasses that will indicate to the patient when to contract the pelvic floor.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Neuromodulation of the tibialis posterior nerve

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Pelvic floor muscle training

Intervention Type: OTHER

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

Interventions

Virtual reality

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

Intervention Type: OTHER

Neuromodulation of the tibialis posterior nerve

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

Intervention Type: OTHER

Pelvic floor muscle training

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Almeria

OTHER

Sponsor Role: lead

Responsible Party

Guadalupe Molina Torres

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guadalupe Molina Torres

Role: PRINCIPAL_INVESTIGATOR

Universidad de Almeria

Jacobo Ángel Rubio-Arias

Role: PRINCIPAL_INVESTIGATOR

Universidad de Almeria

Marta María Córdoba Peláez

Role: PRINCIPAL_INVESTIGATOR

Universidad de Almeria

Other Identifiers

UALBIO2024/015

Identifier Type: -

Identifier Source: org_study_id