Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis

NCT ID: NCT06384716

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2024-09-01

Brief 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. 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.

Conditions

Multiple Sclerosis; Pelvic Floor Disorders; Incontinence, Urinary

Study Design

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

Study Groups

Experimental Group 1

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.

Group Type: EXPERIMENTAL

rehabilitation programme based on motor control of core muscles

Intervention Type: OTHER

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.

Control group

The control group will be evaluated before and after 8 weeks and will continue with their usual treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

rehabilitation programme based on motor control of core muscles

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• - 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.

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia Estrada-Barranco, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

Cecilia Estrada Barranco

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Cecilia Estrada-Barranco, PhD

Role: CONTACT

cecilia.estrada@universidadeuropea.es

686166483

Estherl Delgado, PhD

Role: CONTACT

esther.delgado@universidadeuropea.es

686166483

Facility Contacts

Cecilia Estrada-Barranco, PhD

Role: primary

cecilia.estrada@universidadeuropea.es

686166483

Esther Delgado, PhD

Role: backup

esther.delgado@universidadeuropea.es

Other Identifiers

CEB

Identifier Type: -

Identifier Source: org_study_id