Effect of the Vojta Therapy in Patients Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effect of the Vojta Therapy on Lipid Biomarkers Related to Myelin in Subjects With Multiple Sclerosis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05558683
• Other study ID #: MultipleSclerosisVojta
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2022
• Source: Instituto de Neurociencia de Castillas y Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Randomized clinical trial.
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aymara Abreu Corrales	University of Salamanca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory function	Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.	5 minutes
Primary	Spasticity	Spasticity will be measured using the Tardieu scale.	10 minutes
Primary	Balance	The balance will be measured through the Berg scale.	10 minutes
Primary	Age		1 minutes
Primary	Time reaction	Reaction time will be measured by the Cognifit test	5 minutes
Secondary	Myelin	Myelin will be me measured trough the tear duct whit phospholipid test strips	15 minutes