NCT04317950

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 28, 2020

Last Update Submit

February 5, 2021

Conditions

Brain

Keywords

ElectroencephalographyElectromyographyTactile stimulationVojta therapy

Outcome Measures

Primary Outcomes (2)

  • Electroencephalography (EEG)

    EEG power in alpha and beta bands

    10 minutes per patient

  • Electromyography (EMG)

    EMG power in Rectus abdominis, wrist extensors and tibialis anterior

    10 minutes per patient

Study Arms (2)

Vojta group

OTHER

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

Control group

SHAM COMPARATOR

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

Other: Sham

Interventions

VojtaOTHER

Reflex locomotion stimulus

Vojta group
ShamOTHER

sham stimulus

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberto Cano de la Cuerda

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33478517DERIVED

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

  • Ismael Sanz, PhD

    UEM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 23, 2020

Study Start

January 8, 2020

Primary Completion

March 1, 2020

Study Completion

March 15, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)