Status unknownNot a drug-phase studyMS (type not specified)NCT06384716

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • rehabilitation programme based on motor control of core muscles

What it measured

Main measures

  • Difference in the percentage of initial and final maximum activity of the pelvic floor muscles.

    8 weeks

  • - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound.

    8 weeks

  • - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire.

    8 weeks

    Quality of life (reported by participants)
  • - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire

    8 weeks

Other measures (5)

  • - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity.

    8 weeks

  • - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound.

    8 weeks

  • - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1)

    8 weeks

  • differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP).

    8 weeks

    Physical function
  • balance

    8 weeks

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 70

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Feb 2024

    2. Main results due

      Jul 2024

    3. Finished

      Sept 2024

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error