Clinical trial NCT05558683: Effect of the Vojta Therapy in Patients Multiple Sclerosis
Official title: Effect of the Vojta Therapy on Lipid Biomarkers Related to Myelin in Subjects With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Vojta Therapy
Bobath Therapy
Lead sponsor: Instituto de Neurociencia de Castillas y Leon
Sponsor class: OTHER
Collaborators: name: University of Salamanca
First posted: 2022-09-28
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Our study will be a Randomized Clinical Trial. It will be held at the Aymara Abreu Physiotherapy Clinic center, with a maximum duration of 1 year. It will consist of two parts. In the first stage of the treatment we will carry out an initial assessment, and in the second stage a final assessment. After that, the corresponding data analysis will be carried out.
Primary purpose: TREATMENT

Brief summary: Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. Clinically, MS manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction.

The main subtypes of MS are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. Clinically, RRMS presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. Approximately 40-50% of these patients progress to SPMS, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. PPMS is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.

Detailed description: From the field of Physiotherapy, one of the main tools for the treatment of MS is physical exercise. Numerous studies show that exercising is safe and beneficial in people with MS, as long as it is done correctly and supervised by health professionals. Physical exercise is considered an important part of symptomatic and supportive treatment for people with MS, since it induces improvement of physiological functions affected by lack of physical activity and helps to manage some symptoms, such as spasticity, fatigue and lack of balance There are therapies within Physiotherapy that help treat MS such as the Vojta Method and the Bobath Method.

Eligibility criteria: Inclusion criteria:

* Persons with MS who have signed the informed consent.
* Persons of both sexes.
* Ages between 20 and 65 years.
* Subjects of both sexes diagnosed with multiple sclerosis on the EDSS (Expanded Disability Status Scale).

Exclusion criteria:

* Persons with multiple sclerosis with EDSS scale score equal to or greater than 7.0.
* Occurrence of a flare during the period of the patient's participation in the study.
* Pregnant women.
* Oncology patients.
* Non-acceptance and non-signing of informed consent.
* Refusal to participate in the study.
* Patients with severe cognitive impairment that does not allow them to understand the development of the study.
* Patients with cardiovascular instability.
* Patients who do not complete at least 75% of the scheduled sessions. Patients who do not present any of the contraindications contemplated for Vojta therapy.

Primary outcomes:
measure: Respiratory function
timeFrame: 5 minutes
measure: Spasticity
timeFrame: 10 minutes
measure: Balance
timeFrame: 10 minutes
measure: Age
timeFrame: 1 minutes
measure: Time reaction
timeFrame: 5 minutes
Secondary outcomes:
measure: Myelin
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
References: