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

Multiple Sclerosis Clinical Trial

Official title:

Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program on Pelvic Floor Function in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384716
• Other study ID #: CEB
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Universidad Europea de Madrid
• Contact: Cecilia Estrada-Barranco, PhD
• Phone: 686166483
• Email: cecilia.estrada[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Multiple Sclerosis
• Pelvic Floor Disorders
• Sclerosis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
Spain	Cecilia Estrada Barranco	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the percentage of initial and final maximum activity of the pelvic floor muscles.	EMG	8 weeks
Primary	- Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound.	US	8 weeks
Primary	- Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire.	IQOL	8 weeks
Primary	- Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire	I-CIQ	8 weeks
Secondary	- Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity.	EMG	8 weeks
Secondary	- Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound.	US	8 weeks
Secondary	- Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1)	spirometry	8 weeks
Secondary	differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP).	PIM/PEM	8 weeks
Secondary	balance	trunk control test and Berg Balance test	8 weeks