Cerebral Oxygenation During Vojta Therapy in Healthy Adults Using Near-infrared Spectroscopy

NCT ID: NCT05170906

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-01

Brief Summary

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A randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control).

The objective is to assess neurophysiological activation by measuring oxygenation in the supplementary motor and premotor areas of oxygenation in the supplementary motor and premotor areas, through near infrared spectroscopy (NIRS) in healthy subjects spectroscopy (NIRS) in healthy subjects during the application of Vojta Therapy.

Detailed Description

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Conditions

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Healthy Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Group

The subject will be placed on a stretcher with the torso uncovered. Once the spectroscopy helmet is in place, a recording of the resting activity will be started, two minutes of stimulation (digital pressure), one minute of rest, two minutes of stimulation on the contralateral side and, finally, one minute of rest.

The therapy consists of the application of a stimulating pressure on the pectoral area in the pattern of the reflex swing locomotion complex in its first phase. For this, the subject will be placed in supine decubitus aligned with respect to the axial axis, with the arms alongside the body, the lower extremities in extension and the head extended with a rotation of approximately 30º to one side of the stimulation. Manual stimulation pressure will be exerted in the space between the 6th-7th or 7th-8th ribs below the mammary line, with a force of about 2 kg.

Group Type EXPERIMENTAL

Reflex locomotion stimulus

Intervention Type OTHER

The therapy consists of the application of a stimulating pressure in the pectoral area in the pattern of the locomotion complex of reflex rolling in its first phase. For this, the subject will be placed in a supine position aligned with respect to the axial axis, with the arms along the body, the lower extremities in extension, and the head extended with a rotation of approximately 30º towards one side of the stimulation. The manual stimulation pressure will be exerted in the space between the 6th-7th or the 7th-8th rib under the mammillary line, with a force of about 2 kg.

Control Group

The subject will be placed on a stretcher with the torso uncovered. Once the adhesive electrodes have been placed in the different recording areas on the anterior part of the trunk, a recording of the activity at rest will begin, two minutes of stimulation (digital pressure), one minute of rest, two minutes of stimulation in the contralateral side and, finally, one minute of rest.

The control group will receive an application in an area with low receptor density located on the thigh, with a force of about 2 kg

Group Type SHAM_COMPARATOR

sham stimulus

Intervention Type OTHER

The control group will receive an application in an area with low receptor density located on the thigh, with a force of about 2 kg.

Interventions

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Reflex locomotion stimulus

The therapy consists of the application of a stimulating pressure in the pectoral area in the pattern of the locomotion complex of reflex rolling in its first phase. For this, the subject will be placed in a supine position aligned with respect to the axial axis, with the arms along the body, the lower extremities in extension, and the head extended with a rotation of approximately 30º towards one side of the stimulation. The manual stimulation pressure will be exerted in the space between the 6th-7th or the 7th-8th rib under the mammillary line, with a force of about 2 kg.

Intervention Type OTHER

sham stimulus

The control group will receive an application in an area with low receptor density located on the thigh, with a force of about 2 kg.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Over 18 years old.
* Under 40 years old.
* Full cognitive capacity.

Exclusion Criteria

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Vaccinated in the 10 days prior to the intervention
* Fever
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Juan Luis Sanchez Gonzalez

Dr. Juan Luis Sánchez González

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Juan Luis Sánchez González

Salamanca, , Spain

Site Status

Countries

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Spain

Central Contacts

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Juan Luis S Sánchez González, PhD

Role: CONTACT

660738949

Facility Contacts

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Juan Luis Sánchez González, PhD

Role: primary

660738949

Other Identifiers

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VojaNeurousal

Identifier Type: -

Identifier Source: org_study_id

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