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

Sponsor
University of Salamanca (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05170906
Collaborator
(none)
16
1
2
8
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Reflex locomotion stimulus
  • Other: sham stimulus
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Cerebral Oxygenation During Vojta Therapy in Healthy Adults Using Near-infrared Spectroscopy
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Near Infrared Spectroscopy (NIRS) [15 minutes per patients]

    NIRS power

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Juan Luis Sánchez González Salamanca Spain 37007

Sponsors and Collaborators

  • University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juan Luis Sanchez Gonzalez, Dr. Juan Luis Sánchez González, University of Salamanca
ClinicalTrials.gov Identifier:
NCT05170906
Other Study ID Numbers:
  • VojaNeurousal
First Posted:
Dec 28, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juan Luis Sanchez Gonzalez, Dr. Juan Luis Sánchez González, University of Salamanca

Study Results

No Results Posted as of Jan 14, 2022