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Effect of the Vojta Therapy in Patients Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05558683
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
University of Salamanca
Information provided by (Responsible Party):
Aymara Abreu Corrales, Instituto de Neurociencia de Castillas y Leon

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Randomized clinical trial. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Our population will be subjects diagnosed with MS. Prior to the study, the informed consent will be presented to the subjects. Said confidentiality will be contemplated in Organic Law 15/99 of December 13 on the Protection of personal data.
Primary Purpose: Treatment
Official Title: Effect of the Vojta Therapy on Lipid Biomarkers Related to Myelin in Subjects With Multiple Sclerosis.
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vojta Reflex Locomotion Therapy
The Vojta Method or Vojta Reflex Locomotion Therapy (TLRV) is a rehabilitative method for neuromusculoskeletal pathologies widely used in Europe. Its development is based on the concept of motor ontogenesis and tries to trigger innate motor reactions (reflex locomotion patterns) in the trunk and limbs from defined tactile and proprioceptive stimuli, starting from certain postures. This therapy presents differential elements with respect to other existing therapies, both for neurophysiological principles and for methodological principles. It is an active therapy, in which great concentration is required on the part of the patient, that is, both therapist and patient are the central axes of the treatment.
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.

Active Comparator: Bobath Method
Within physiotherapy, the Bobath concept is a valid and recognized option in the treatment of patients with neurological disorders, and therefore, of those diagnosed with MS. It was developed by Karel and Berta Bobath. The Bobath concept is defined as a problem-solving approach in the assessment and treatment of people with impaired neuromotor function, becoming a valid tool as part of the comprehensive treatment of people with MS
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.




Primary Outcome Measures :
  1. Respiratory function [ Time Frame: 5 minutes ]
    Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.

  2. Spasticity [ Time Frame: 10 minutes ]
    Spasticity will be measured using the Tardieu scale.

  3. Balance [ Time Frame: 10 minutes ]
    The balance will be measured through the Berg scale.

  4. Age [ Time Frame: 1 minutes ]
  5. Time reaction [ Time Frame: 5 minutes ]
    Reaction time will be measured by the Cognifit test


Secondary Outcome Measures :
  1. Myelin [ Time Frame: 15 minutes ]
    Myelin will be me measured trough the tear duct whit phospholipid test strips



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Aymara Abreu Corrales, Principal investigator, Instituto de Neurociencia de Castillas y Leon
ClinicalTrials.gov Identifier: NCT05558683    
Other Study ID Numbers: MultipleSclerosisVojta
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aymara Abreu Corrales, Instituto de Neurociencia de Castillas y Leon:
Vojta Therapy
Bobath Therapy
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases