Multiple SclerosisNCT06576947
Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis
A study testing Virtual reality, Neuromodulation of the tibialis posterior nerve and Pelvic floor muscle training in people with Multiple Sclerosis, run by Universidad de Almeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Virtual reality, Neuromodulation of the tibialis posterior nerve and Pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple sclerosis
- Presence of pelvic floor dysfunction
- Acceptance participation
- Not undergoing another physical therapy treatment
Who cannot join
- Non-acceptance of participation
- Mental illness
- Interruption of adherence to protocolized treatment sessions
- Indication of surgical treatment in the pelvic floor
About this study
Official title: Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Virtual reality, Neuromodulation of the tibialis posterior nerve, Pelvic floor muscle training
- Keywords
- virtual reality, multiple sclerosis, pelvic floor, randomized controlled trial
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Participants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week
Neuromodulation of the tibialis posterior nerveOther
Participants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes
Pelvic floor muscle trainingOther
Participants receive pelvic floor muscle training 5 times a day for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality therapy | Experimental | It will ve placement of virtual reality glasses that will indicate to the patient when to contract the pelvic floor. Receives: 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. Receives: 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. Receives: Other: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
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
Measured: At baseline, immediately after the intervention, and 4 weeks
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).
Measured: 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.
Measured: 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.
Measured: At baseline, immediately after the intervention, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guadalupe Molina Torres, Universidad de Almeria
- Investigators
- Guadalupe Molina Torres, Principal investigator, Universidad de AlmeriaJacobo Ángel Rubio-Arias, Principal investigator, Universidad de AlmeriaMarta María Córdoba Peláez, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576947
- Sponsor's protocol ID
- UALBIO2024/015
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06576947
- Acronym / sponsor ID
- UALBIO2024/015
- Conditions
- Multiple Sclerosis
- Keywords
- virtual reality, multiple sclerosis, pelvic floor, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality therapy | Experimental | Other: Virtual realityIt will ve placement of virtual reality glasses that will indicate to the patient when to contract the pelvic floor. |
| Neuromodulation of the tibialis posterior | Experimental | Other: Neuromodulation of the tibialis posterior nerveIs 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. |
| Pelvic Floor Muscle Training | Experimental | Other: Pelvic floor muscle trainingPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of multiple sclerosis
- Presence of pelvic floor dysfunction
- Acceptance participation
- Not undergoing another physical therapy treatment
Key exclusion criteria (4 listed)
- Non-acceptance of participation
- Mental illness
- Interruption of adherence to protocolized treatment sessions
- Indication of surgical treatment in the pelvic floor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityParticipants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week | Other | Virtual reality therapy |
| Neuromodulation of the tibialis posterior nerveParticipants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes | Other | Neuromodulation of the tibialis posterior |
| Pelvic floor muscle trainingParticipants receive pelvic floor muscle training 5 times a day for 9 weeks | Other | Pelvic Floor Muscle Training |
Primary outcome
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
4 secondary outcomes
Australian pelvic floor questionnaire:
Time frame: At baseline, immediately after the intervention, and 4 weeks
Multiple Sclerosis Quality of Life-54 (MSQOL-54):
Time frame: At baseline, immediately after the intervention, and 4 weeks
Euroqol
Time frame: At baseline, immediately after the intervention, and 4 weeks
SF12
Time frame: At baseline, immediately after the intervention, and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guadalupe Molina Torres principal investigator
Universidad de Almeria
Jacobo Ángel Rubio-Arias principal investigator
Universidad de Almeria
Marta María Córdoba Peláez principal investigator
Universidad de Almeria
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality, Neuromodulation of the tibialis posterior nerve and Pelvic floor muscle training in people with Multiple Sclerosis, run by Universidad de Almeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.