- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04317950
Cortical Activity During Vojta Stimulation in Healthy Adults
Cortical Activity During Sensorial Tactile Stimulation in Healthy Adults. The Innate Patron Activation With Vojta Therapy.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Alcorcón, Madrid, Spain, 28922
- Roberto Cano de la Cuerda
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Reflex locomotion stimulus
|
SHAM_COMPARATOR: Control group
On the contrary, the control group received a continuous sham stimulus during the next 8 minutes.
|
sham stimulus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroencephalography (EEG)
Time Frame: 10 minutes per patient
|
EEG power in alpha and beta bands
|
10 minutes per patient
|
Electromyography (EMG)
Time Frame: 10 minutes per patient
|
EMG power in Rectus abdominis, wrist extensors and tibialis anterior
|
10 minutes per patient
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ismael Sanz, PhD, UEM
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UEMURJC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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