Abdominal Electromyographic Control in Vojta Therapy

• ClinicalTrials.gov Identifier: NCT04818879
• Recruitment Status: Completed
• First Posted: March 26, 2021
• Last Update Posted: September 29, 2021
• Sponsor: University of Salamanca
• Collaborator: Colegio Profesional de Fisioterapeutas de Castilla y León
• Information provided by (Responsible Party): Pérez-Robledo, Fátima, University of Salamanca

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 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.

Condition or disease	Intervention/treatment	Phase
Abdominal Muscles	Other: Vojta; Other: Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Basic Science
• Official Title: Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults
• Actual Study Start Date: April 1, 2021
• Actual Primary Completion Date: April 30, 2021
• Actual Study Completion Date: April 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Date of birth [ Time Frame: Baseline ]
   It will be registered at the beginning of the study in order to calculate the age of the participant.
2. Sex [ Time Frame: Baseline ]
   It will be registered at the beginning of the study.
3. Height [ Time Frame: Baseline ]
   It will be registered at the beginning of the study in centimeters.
4. Weight [ Time Frame: Baseline ]
   It will be registered at the beginning of the study in kilograms.
5. International Physical Activity Questionnaire [ Time Frame: Baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Spain

Universidad de Salamanca

Salamanca, Spain, 37007

Sponsors and Collaborators

University of Salamanca

Colegio Profesional de Fisioterapeutas de Castilla y León

Investigators

• Principal Investigator: Fátima Pérez-Robledo, PhD; University of Salamanca

More Information

• Responsible Party: Pérez-Robledo, Fátima, Professor, University of Salamanca
• ClinicalTrials.gov Identifier: NCT04818879
• Other Study ID Numbers: NEUROUSAL04/2021
• First Posted: March 26, 2021
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pérez-Robledo, Fátima, University of Salamanca:

Electromyography; Abdominal Muscles; Muscle Contraction; Outcome and Process Assessment; Health Care