NCT04818879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

29 days

First QC Date

March 21, 2021

Last Update Submit

September 28, 2021

Conditions

Keywords

ElectromyographyAbdominal MusclesMuscle ContractionOutcome and Process AssessmentHealth Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Date of birth

    Baseline

  • Sex

    Baseline

  • Height

    Baseline

  • Weight

    Baseline

  • International Physical Activity Questionnaire

    Baseline

Study Arms (2)

Interventional group

EXPERIMENTAL
Other: Vojta

Control group

SHAM COMPARATOR
Other: Control

Interventions

VojtaOTHER

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.

Interventional group
ControlOTHER

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old.
  • Full cognitive capacity.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Salamanca

Salamanca, 37007, Spain

Location

Study Officials

  • Fátima Pérez-Robledo, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 26, 2021

Study Start

April 1, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations