Clinical trial NCT06384716: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis
Official title: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program on Pelvic Floor Function in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Pelvic Floor Disorders
Incontinence, Urinary
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference in the percentage of initial and final maximum activity of the pelvic floor muscles.
timeFrame: 8 weeks
measure: - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound.
timeFrame: 8 weeks
measure: - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire.
timeFrame: 8 weeks
measure: - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity.
timeFrame: 8 weeks
measure: - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound.
timeFrame: 8 weeks
measure: - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1)
timeFrame: 8 weeks
measure: differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP).
timeFrame: 8 weeks
measure: balance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Cecilia Estrada Barranco
Study officials:
affiliation: Universidad Europea de Madrid
name: Cecilia Estrada-Barranco, PhD
role: PRINCIPAL_INVESTIGATOR
References: