Effect of the Vojta Therapy in Patients Multiple Sclerosis

NCT05558683 | Unknown

• 1 other identifier: MultipleSclerosisVojta
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Vojta Therapy; Bobath Therapy

Outcome Measures

Primary Outcomes (5)

• Respiratory function

  Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.

  5 minutes

• Spasticity

  Spasticity will be measured using the Tardieu scale.

  10 minutes

• Balance

  The balance will be measured through the Berg scale.

  10 minutes

• Age

  1 minutes

• Time reaction

  Reaction time will be measured by the Cognifit test

  5 minutes

Secondary Outcomes (1)

• Myelin

  15 minutes

Study Arms (2)

Vojta Reflex Locomotion Therapy

ACTIVE COMPARATOR

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.

Bobath Method

ACTIVE COMPARATOR

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.

Interventions

Randomized clinical trial. OTHER

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.

Bobath Method; Vojta Reflex Locomotion Therapy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aymara Abreu Corrales: lead
• University of Salamanca: collaborator

Related Publications (1)

• Abreu-Corrales A, Velasco A, Cuesta-Gomez A, Sanchez-Gonzalez JL. Impact of reflex locomotion and the Bobath concept on clinical and biomolecular parameters in people with multiple sclerosis: study protocol for a randomized controlled trial. Front Neurol. 2023 Aug 4;14:1209477. doi: 10.3389/fneur.2023.1209477. eCollection 2023.

  PMID: 37602251 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Randomized Controlled Trials as Topic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Controlled Clinical Trials as Topic; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: September 28, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share