CClinicalTrials.gg
Status unknownNCT05558683Updated Sep 28, 2022

Effect of the Vojta Therapy in Patients Multiple Sclerosis

An interventional study of Randomized clinical trial. in Multiple Sclerosis, sponsored by Aymara Abreu Corrales. Status unknown. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by Aymara Abreu Corrales · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Vojta Therapy
  • Bobath Therapy
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 25 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

This is the only study on the registry with Aymara Abreu Corrales as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • 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.

  • 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.

Interventions

  • OtherRandomized 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.

06

What researchers measure

Primary outcomes

  1. Respiratory function

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

    Time frame: 5 minutes

  2. Spasticity

    Spasticity will be measured using the Tardieu scale.

    Time frame: 10 minutes

  3. Balance

    The balance will be measured through the Berg scale.

    Time frame: 10 minutes

  4. Age

    Time frame: 1 minutes

  5. Time reaction

    Reaction time will be measured by the Cognifit test

    Time frame: 5 minutes

Secondary outcomes

  1. Myelin

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

    Time frame: 15 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05558683
Lead sponsor
Aymara Abreu Corrales
Collaborators
University of Salamanca
Responsible party
Aymara Abreu Corrales (Principal investigator, Instituto de Neurociencia de Castillas y Leon) — Sponsor-investigator
First posted
Sep 28, 2022
Start date
Dec 1, 2022 (estimated)
Primary completion
Jun 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Sep 28, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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