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

NCT06576947 | Not Yet Recruiting

• 1 other identifier: UALBIO2024/015
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

virtual reality; multiple sclerosis; pelvic floor; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Australian pelvic floor questionnaire:

  At baseline, immediately after the intervention, and 4 weeks

• Multiple Sclerosis Quality of Life-54 (MSQOL-54):

  At baseline, immediately after the intervention, and 4 weeks

• Euroqol

  At baseline, immediately after the intervention, and 4 weeks

• SF12

  At baseline, immediately after the intervention, and 4 weeks

Study Arms (3)

Virtual reality therapy

EXPERIMENTAL

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

Other: Virtual reality

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.

Other: Neuromodulation of the tibialis posterior nerve

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.

Other: Pelvic floor muscle training

Interventions

Virtual reality OTHER

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

Virtual reality therapy

Neuromodulation of the tibialis posterior nerve OTHER

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

Neuromodulation of the tibialis posterior

Pelvic floor muscle training OTHER

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

Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Almeria: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind (Subject)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08