Expert vs. Non-expert Abdominal Electromyographic Control in Vojta Therapy

Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults: Expert vs Non-expert Comparison

Randomized clinical trial on a cohort of healthy subjects of legal age, of both sexes, recruited from the university community and who will be randomly distributed into two groups (expert therapist vs. non-expert therapist). The objective will be to determine if there are differences in the muscular activation produced on the stabilizing muscles of the trunk (external oblique and internal oblique) if it is applied by an expert therapist versus if it is applied by a therapist not specialized in therapy and to know the effects produced on the muscles studied after performing the intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Muscles
• Intervention / Treatment: Other: Vojta Therapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Luis Sánchez González, PhD; Phone Number: +34 660 738 949; Email: juanluissanchez@usal.es
• Study Contact Backup: Name: Fátima Pérez Robledo, PhD; Phone Number: +34 619 885 479; Email: fatima_pr@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expert group; The stimulation will be applied by an expert therapist.	Other: Vojta Therapy; 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.
Active Comparator: Non-expert group; This group will receive the same stimulation as the expert group but in this case it will be applied by a therapist not specialized in therapy.	Other: Vojta Therapy; 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.

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

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Electromyography; Muscle Contraction; Outcome and Process Assessment; Health Care; Expert Therapist
• Other Study ID Numbers: NEUROUSAL04/2023

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