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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental | 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:
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| Control group | No Intervention | The control group will be evaluated before and after 8 weeks and will continue with their usual treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rehabilitation programme based on motor control of core muscles | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecilia Estrada-Barranco, PhD | Contact | 686166483 | cecilia.estrada@universidadeuropea.es | |
| Estherl Delgado, PhD | Contact | 686166483 | esther.delgado@universidadeuropea.es |
| Name | Affiliation | Role |
|---|---|---|
| Cecilia Estrada-Barranco, PhD | Universidad Europea de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cecilia Estrada Barranco | Recruiting | Madrid | Spain |
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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
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|
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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D059952 | Pelvic Floor Disorders |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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