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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Pelvic Floor Disorders; Incontinence, Urinary
• Intervention / Treatment: Other: rehabilitation programme based on motor control of core muscles

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia Estrada-Barranco, PhD; Phone Number: 686166483; Email: cecilia.estrada@universidadeuropea.es
• Study Contact Backup: Name: Estherl Delgado, PhD; Phone Number: 686166483; Email: esther.delgado@universidadeuropea.es

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Cecilia Estrada Barranco
    • Contact: Cecilia Estrada-Barranco, PhD; Phone Number: 686166483; Email: cecilia.estrada@universidadeuropea.es
    • Contact: Esther Delgado, PhD; Email: esther.delgado@universidadeuropea.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: - First week: Sensitisation and voluntary work of the pelvic floor musculature without increasing the increase in intra-abdominal pressure.; - Second week: Work on respiratory motor control and activation of the pelvic floor.; - Third and fourth week: Motor control work with progressive increase in intra-abdominal pressure.; - Fifth and sixth week: Work on dynamic motor control in dual-task situations.; - Seventh and eighth week: Core motor control work in functional activities.	Other: 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.
No Intervention: Control group; The control group will be evaluated before and after 8 weeks and will continue with their usual treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the percentage of initial and final maximum activity of the pelvic floor muscles.	EMG	8 weeks
- Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound.	US	8 weeks
- Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire.	IQOL	8 weeks
- Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire	I-CIQ	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity.	EMG	8 weeks
- Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound.	US	8 weeks
- Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1)	spirometry	8 weeks
differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP).	PIM/PEM	8 weeks
balance	trunk control test and Berg Balance test	8 weeks

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Cecilia Estrada-Barranco, PhD, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Multiple Sclerosis; Sclerosis; Urinary Incontinence; Enuresis; Pelvic Floor Disorders
• Other Study ID Numbers: CEB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No