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

Not Applicable

• Conditions: Healthy; Brain
• Interventions: Other: sham stimulus; Other: Reflex locomotion stimulus

• Registration Number: NCT05170906
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-11
• Study First Submitted QC: 2021-12-11
• Study First Posted: 2021-12-28
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14
• Study Start: 2022-04-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	sham stimulus	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
Experimental Group	Reflex locomotion stimulus	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.

Primary Outcome Measures

Name	Time	Method
Near Infrared Spectroscopy (NIRS)	15 minutes per patients	NIRS power

Trial Locations

Locations (1)

Juan Luis Sánchez González; 🇪🇸 Salamanca, Spain