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CompletedNCT04317950Updated Feb 10, 2021

Cortical Activity During Vojta Stimulation in Healthy Adults

An interventional study of Vojta and Sham in Brain, sponsored by Josue Fernandez Carnero. Completed at 1 site in Spain. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Josue Fernandez Carnero · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The present study is focused on the importance of sensory stimuli at the tactile and proprioceptive level that occur during the activation of the pectoral area, following the treatment protocol of Vojta Therapy (VT), and which are the areas that are activated in the central nervous system (CNS) during stimulation, as well as muscle activity. For the activation record it will be used electroencephalography and electromyography electrods.

Read the detailed description

The relationship between intrinsic and extrinsic factors condition the development of the human being. The sensory organs are the main recipients of the information, thanks to them we are able to interact with the environment and register the influence of the stimuli inside the organism. The brain receives information from the environment through its senses.

At the tactile level the brain receives afferent information thanks to the activation of mechanoreceptors of the skin during interaction with the environment. The receivers encode the stimulus information and send it to the specific CNS structures. In these structures, the sensations received are combined and the stimulus is transformed into a perfectly elaborated response, both in a conscious and innate way.

Dr. Vojta showed in 1974 the locomotion reflects the result of the study of motor ontogenesis. This discovery was the demonstration of the existence of innate and preprogrammed motor patterns in Humans.

Most of the studies related to VT have showed the improvements obtained by the patients, validating it as a method of treatment and evidencing objective changes after its application. This research aim to go further and verify that cortical areas are activated during the application of an external and proprioceptive stimuli that are performed during the first phase of VT turning and which areas are responsible for producing and organizing the efferent response.

02

Conditions studied

  • Brain

Keywords

  • Electroencephalography
  • Electromyography
  • Tactile stimulation
  • Vojta therapy
03

In context

Lead sponsor

Josue Fernandez Carnero is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult population with no history of neurological disease or others that may affect the test.
  • Age between 18 and 50 years.
  • Not having addiction to alcohol or drugs at the time of the study.
  • Not knowing the basics of Vojta Therapy, or knowing the responses of stimuli when applying therapy.
  • Not having the pharmacological treatment that affects the functioning of the Central Nervous System and may interfere with the test results.

Exclusion criteria

Exclusion Criteria:

  • Those who do not meet the inclusion criteria
  • Not having suffered ms-skeletal alterations in the last 6 months.
  • Known sensory abnormalities.
  • Diagnosis of some neurological pathology or condition that could alter the study such as pain, radiculopathy.
  • Refuse to sign the informed consent.
  • Claustrophobia.
  • Those that can spoil the magnetic resonance image.

    • Be a carrier of some metallic material.
    • Pregnancy or nursing mother.
  • The contraindications of Vojta Therapy.

    • Acute diseases that present with fever and / or inflammation.
    • Vaccination with live germs, according to medical criteria (usually 10 days after vaccination).
    • In case of crystal bone disease, uncontrolled heart disease.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (actual)

Study arms

  • Other
    Vojta group

    All participants were properly instructed and signed an informed consent previous to the interventions. They were comfortably laid down on their back with eyes open, wearing the EEG cap and electromyography electrodes during the intervention. They were asked to remain relaxed and still during the whole process. After a first minute of resting, the experimental group received a continuous reflex locomotion stimulus during the next 8 minutes.

    Other: Vojta

  • Sham comparator
    Control group

    On the contrary, the control group received a continuous sham stimulus during the next 8 minutes.

    Other: Sham

Interventions

  • OtherVojta

    Reflex locomotion stimulus

  • OtherSham

    sham stimulus

06

What researchers measure

Primary outcomes

  1. Electroencephalography (EEG)

    EEG power in alpha and beta bands

    Time frame: 10 minutes per patient

  2. Electromyography (EMG)

    EMG power in Rectus abdominis, wrist extensors and tibialis anterior

    Time frame: 10 minutes per patient

07

Study locations

1 site
  • Roberto Cano de la Cuerda
    Alcorcón, Madrid 28922, Spain
08

References and documents

Publications

  • Sanz-Esteban I, Cano-de-la-Cuerda R, San-Martin-Gomez A, Jimenez-Antona C, Monge-Pereira E, Estrada-Barranco C, Serrano JI. Cortical activity during sensorial tactile stimulation in healthy adults through Vojta therapy. A randomized pilot controlled trial. J Neuroeng Rehabil. 2021 Jan 21;18(1):13. doi: 10.1186/s12984-021-00824-4. PubMed 33478517 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04317950
Lead sponsor
Josue Fernandez Carnero
Collaborators
Universidad Europea de Madrid
Responsible party
Josue Fernandez Carnero (Clinical Professor, Universidad Rey Juan Carlos) — Sponsor-investigator
First posted
Mar 23, 2020
Start date
Jan 8, 2020
Primary completion
Mar 1, 2020
Completion
Mar 15, 2020
Last update
Feb 10, 2021

Study contacts

Ismael Sanz, PhD
principal investigator · UEM

Oversight

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

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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