Abdominal Electromyographic Control in Vojta Therapy

Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults

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 will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.

Study Overview

• Status: Completed
• Conditions: Abdominal Muscles
• Intervention / Treatment: Other: Vojta; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Universidad de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 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: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group	Other: Vojta; 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 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	Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyographic activity in abdominal muscles	The electromyographic activity of internal and external obliques in nanovolts will be collected before, during and after the intervention.	Change from Baseline electromyographic activity at 7 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Date of birth	It will be registered at the beginning of the study in order to calculate the age of the participant.	Baseline
Sex	It will be registered at the beginning of the study.	Baseline
Height	It will be registered at the beginning of the study in centimeters.	Baseline
Weight	It will be registered at the beginning of the study in kilograms.	Baseline
International Physical Activity Questionnaire	It will be measured at the beginning of the study to quantify the level of physical activity of the participant. This validated scale allows you to determine if you have a low, moderate or high physical level.	Baseline

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Colegio Profesional de Fisioterapeutas de Castilla y León
• Investigators: Principal Investigator: Fátima Pérez-Robledo, PhD, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Electromyography; Abdominal Muscles; Muscle Contraction; Outcome and Process Assessment; Health Care
• Other Study ID Numbers: NEUROUSAL04/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No