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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Brain
• Intervention / Treatment: Other: Reflex locomotion stimulus; Other: sham stimulus

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Luis S Sánchez González, PhD; Phone Number: 660738949; Email: juanluissanchez@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Juan Luis Sánchez González
    • Contact: Juan Luis Sánchez González, Phd; Phone Number: 660738949; Email: juanluissanchez@usal.es
    • Sub-Investigator: Rocio Llamas Ramos, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Sham Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Infrared Spectroscopy (NIRS)	NIRS power	15 minutes per patients

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: December 11, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Adult; Vojta Therapy; Oxigenation
• Other Study ID Numbers: VojaNeurousal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No