NCT06159426

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Status
unknown

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

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

November 28, 2023

Last Update Submit

December 7, 2023

Conditions

Keywords

ElectromyographyMuscle ContractionExpert TherapistOutcome 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 (4)

  • Date of birth

    Baseline

  • Sex

    Baseline

  • Height

    Baseline

  • Weight

    Baseline

Study Arms (2)

Expert group

EXPERIMENTAL

The stimulation will be applied by an expert therapist.

Other: Vojta Therapy

Non-expert group

ACTIVE COMPARATOR

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

Interventions

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.

Expert groupNon-expert 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

Central Study Contacts

Juan Luis Sánchez González, PhD

CONTACT

Fátima Pérez Robledo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor doctor

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

December 10, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

December 14, 2023

Record last verified: 2023-12