Multiple SclerosisNCT06384716
Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis
A study of Multiple Sclerosis and Pelvic Floor Disorders, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Pelvic Floor Disorders, Incontinence, Urinary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2024to 1 Sep 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age between 18 and 70 years.
- Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with an evolution time of more than two years (remitting or progressive) (24).
- Multiple Sclerosis Disability Status Scale (EDSS) score between 2 (minimal disability in one of the functional systems), and 7.5 (inability to take more than a few steps. Limited to wheelchair and transfer support. Ability to move the chair, but not all day if the chair is conventional and lacks a motor) (25, 26).
- Stable medical treatment for at least six months prior to surgery (26).
- Absence of cognitive impairment, with ability to understand instructions and score 24 or higher on the Minimental Test (27).
- Urinary incontinence as a consequence of neurological involvement.
Who cannot join
- - Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
- Diagnosis of any cardiovascular, respiratory, genitourinary, metabolic or other conditions that may interfere with this study.
- Having presented urinary incontinence prior to the diagnosis of MS.
- Have suffered an exacerbation or hospitalisation in the last 3 months before starting the assessment protocol, or during the therapeutic intervention process.
- Have received a course of intravenous or oral steroids 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Cecilia Estrada Barranco
Madrid
Cecilia Estrada-Barranco, PhD, 686166483, cecilia.estrada@universidadeuropea.es
Esther Delgado, PhD, esther.delgado@universidadeuropea.es
About this study
Official title: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program on Pelvic Floor Function in Patients With Multiple Sclerosis
Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control.
Read the detailed description
Main objective:
To establish the effect of core motor control training on pelvic floor functionality in patients with multiple sclerosis.
Specific objective: To assess the effect of core motor control training on urinary incontinence.
- To assess the effect of core motor control training on urinary incontinence in patients with multiple sclerosis.
- To assess the effect of core motor control training on quality of life in patients with multiple sclerosis.
- To assess the effect of core motor control training on sexual dysfunction in patients with multiple sclerosis.
- To assess the effect of core motor control training on balance in patients with multiple sclerosis.
- To test the relationship between respiratory functionality and pelvic floor dysfunctions in patients with multiple sclerosis.
- Being tested
- rehabilitation programme based on motor control of core muscles
- Medical subject headings
- Multiple Sclerosis, Pelvic Floor Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation programme based on motor control of core musclesOther
The exercises performed during the intervention aim to improve the functionality of MS patients and to assess how this can improve pelvic floor health, quality of life, sexual health and urinary incontinence. A specific exercise programme has been designed and will be carried out by physiotherapists specialised in neurological physiotherapy for this purpose. The ultimate aim of the research is to be able to benefit other MS patients from our findings and to propose specific interventions in these areas. However, it is possible that no direct benefit will be obtained after the intervention. At the end of the research you will be informed, if you wish, about the main results and general conclusions of the study. The study does not pose any risk to your health as it is a non-invasive study and no harmful or deleterious action is incurred for the additional collection of the necessary records.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | The intervention group will come to receive the treatment focused on training the motor control of the CORE. This intervention will consist of two sessions per week in which different levels of intervention will be established:
1. - First week: Sensitisation and voluntary work of the pelvic floor musculature without increasing the increase in intra-abdominal pressure.
2. - Second week: Work on respiratory motor control and activation of the pelvic floor.
3. - Third and fourth week: Motor control work with progressive increase in intra-abdominal pressure.
4. - Fifth and sixth week: Work on dynamic motor control in dual-task situations.
5. - Seventh and eighth week: Core motor control work in functional activities. Receives: Other: rehabilitation programme based on motor control of core muscles |
| Control group | No intervention | The control group will be evaluated before and after 8 weeks and will continue with their usual treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the percentage of initial and final maximum activity of the pelvic floor muscles.
EMG
Measured: 8 weeks
- Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound.
US
Measured: 8 weeks
- Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire.
IQOL
Measured: 8 weeks
- Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire
I-CIQ
Measured: 8 weeks
Secondary outcomes (5)
- Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity.
EMG
Measured: 8 weeks
- Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound.
US
Measured: 8 weeks
- Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1)
spirometry
Measured: 8 weeks
differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP).
PIM/PEM
Measured: 8 weeks
balance
trunk control test and Berg Balance test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start19 Feb 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (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
- Model description
- This is a randomised clinical trial. The research will be conducted in accordance with the framework of application of the Helsinki declaration (21) and the law on Personal Data Protection and guarantee of digital rights (Organic Law 3/2018) . The design of this project will follow the definition of the standard elements of a clinical trial protocol: SPIRIT declaration
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Estrada-Barranco, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384716
- Sponsor's protocol ID
- CEB
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program on Pelvic Floor Function in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06384716
- Acronym / sponsor ID
- CEB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 25 Apr 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.
Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control.
Detailed description
Main objective:
To establish the effect of core motor control training on pelvic floor functionality in patients with multiple sclerosis.
Specific objective: To assess the effect of core motor control training on urinary incontinence.
- To assess the effect of core motor control training on urinary incontinence in patients with multiple sclerosis.
- To assess the effect of core motor control training on quality of life in patients with multiple sclerosis.
- To assess the effect of core motor control training on sexual dysfunction in patients with multiple sclerosis.
- To assess the effect of core motor control training on balance in patients with multiple sclerosis.
- To test the relationship between respiratory functionality and pelvic floor dysfunctions in patients with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a randomised clinical trial. The research will be conducted in accordance with the framework of application of the Helsinki declaration (21) and the law on Personal Data Protection and guarantee of digital rights (Organic Law 3/2018) . The design of this project will follow the definition of the standard elements of a clinical trial protocol: SPIRIT declaration
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: rehabilitation programme based on motor control of core musclesThe intervention group will come to receive the treatment focused on training the motor control of the CORE. This intervention will consist of two sessions per week in which different levels of intervention will be established: 1. - First week: Sensitisation and voluntary work of the pelvic floor musculature without increasing the increase in intra-abdominal pressure. 2. - Second week: Work on respiratory motor control and activation of the pelvic floor. 3. - Third and fourth week: Motor control work with progressive increase in intra-abdominal pressure. 4. - Fifth and sixth week: Work on dynamic motor control in dual-task situations. 5. - Seventh and eighth week: Core motor control work in functional activities. |
| Control group | No intervention | –The control group will be evaluated before and after 8 weeks and will continue with their usual treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Age between 18 and 70 years.
- Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with an evolution time of more than two years (remitting or progressive) (24).
- Multiple Sclerosis Disability Status Scale (EDSS) score between 2 (minimal disability in one of the functional systems), and 7.5 (inability to take more than a few steps. Limited to wheelchair and transfer support. Ability to move the chair, but not all day if the chair is conventional and lacks a motor) (25, 26).
- Stable medical treatment for at least six months prior to surgery (26).
- Absence of cognitive impairment, with ability to understand instructions and score 24 or higher on the Minimental Test (27).
Key exclusion criteria (5 listed)
- - Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
- Diagnosis of any cardiovascular, respiratory, genitourinary, metabolic or other conditions that may interfere with this study.
- Having presented urinary incontinence prior to the diagnosis of MS.
- Have suffered an exacerbation or hospitalisation in the last 3 months before starting the assessment protocol, or during the therapeutic intervention process.
- Have received a course of intravenous or oral steroids 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
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 |
|---|---|---|
| rehabilitation programme based on motor control of core musclesThe exercises performed during the intervention aim to improve the functionality of MS patients and to assess how this can improve pelvic floor health, quality of life, sexual health and urinary incontinence. A specific exercise programme has been designed and will be carried out by physiotherapists specialised in neurological physiotherapy for this purpose. The ultimate aim of the research is to be able to benefit other MS patients from our findings and to propose specific interventions in these areas. However, it is possible that no direct benefit will be obtained after the intervention. At the end of the research you will be informed, if you wish, about the main results and general conclusions of the study. The study does not pose any risk to your health as it is a non-invasive study and no harmful or deleterious action is incurred for the additional collection of the necessary records. | Other | Experimental Group 1 |
Primary outcome
Difference in the percentage of initial and final maximum activity of the pelvic floor muscles.
Time frame: 8 weeks
EMG
- Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound.
Time frame: 8 weeks
US
- Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire.
Time frame: 8 weeks
IQOL
- Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire
Time frame: 8 weeks
I-CIQ
5 secondary outcomes
- Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity.
Time frame: 8 weeks
- Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound.
Time frame: 8 weeks
- Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1)
Time frame: 8 weeks
differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP).
Time frame: 8 weeks
balance
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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.
Cecilia Estrada-Barranco, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Multiple Sclerosis and Pelvic Floor Disorders, run by Universidad Europea de Madrid at 1 site in Spain.
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 6 inclusion and 5 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Cecilia Estrada-Barranco, PhD (686166483, cecilia.estrada@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the percentage of initial and final maximum activity of the pelvic floor muscles. (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 25 Apr 2024.