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Effect of the Vojta Therapy in Patients Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Randomized clinical trial.
Sponsored by
Aymara Abreu Corrales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Vojta Therapy, Bobath Therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Vojta Reflex Locomotion Therapy

    Bobath Method

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    Respiratory function
    Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.
    Spasticity
    Spasticity will be measured using the Tardieu scale.
    Balance
    The balance will be measured through the Berg scale.
    Age
    Time reaction
    Reaction time will be measured by the Cognifit test

    Secondary Outcome Measures

    Myelin
    Myelin will be me measured trough the tear duct whit phospholipid test strips

    Full Information

    First Posted
    April 15, 2022
    Last Updated
    September 26, 2022
    Sponsor
    Aymara Abreu Corrales
    Collaborators
    University of Salamanca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05558683
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Aymara Abreu Corrales
    Collaborators
    University of Salamanca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Vojta Therapy, Bobath Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vojta Reflex Locomotion Therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Bobath Method
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Randomized clinical trial.
    Intervention 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 Outcome Measure Information:
    Title
    Respiratory function
    Description
    Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.
    Time Frame
    5 minutes
    Title
    Spasticity
    Description
    Spasticity will be measured using the Tardieu scale.
    Time Frame
    10 minutes
    Title
    Balance
    Description
    The balance will be measured through the Berg scale.
    Time Frame
    10 minutes
    Title
    Age
    Time Frame
    1 minutes
    Title
    Time reaction
    Description
    Reaction time will be measured by the Cognifit test
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Myelin
    Description
    Myelin will be me measured trough the tear duct whit phospholipid test strips
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of the Vojta Therapy in Patients Multiple Sclerosis

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