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

NCT05170906 | Unknown

• 1 other identifier: VojaNeurousal
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Brain

Keywords

Adult; Vojta Therapy; Oxigenation

Outcome Measures

Primary Outcomes (1)

• Near Infrared Spectroscopy (NIRS)

  NIRS power

  15 minutes per patients

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Reflex locomotion stimulus

Control Group

SHAM COMPARATOR

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

Other: sham stimulus

Interventions

Reflex locomotion stimulus 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.

Experimental Group

sham stimulus 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Juan Luis Sánchez González

Salamanca, 37007, Spain

Location

Central Study Contacts

Juan Luis S Sánchez González, PhD

CONTACT

660738949; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Juan Luis Sánchez González

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 28, 2021
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)