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Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury. (ElectroVojta)

Primary Purpose

Abdominal Muscles

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vojta Therapy
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Muscles

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Brain injury group Inclusion Criteria : Over 18 and under 80 years of age Persons with a medical diagnosis of brain damage secondary to stroke Have preserved the ability to walk, even with some type of orthopedic some type of orthopedic aid, Exclusion Criteria: Over 80 years Healthy people Group without brain damage Inclusion Criteria : Over 18 and under 80 years of age Healthy people 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. Fever

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention group for people with brain damage

    Intervention group for people without brain damage

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Electromyographic activity in abdominal muscles
    The electromyographic activity of internal and external obliques in nanovolts will be collected before, during and after the intervention. Acquired signals are sampled at 1 KHz and filtered with a 60 Hz high pass digital filter to reject signals of non-muscular origin. The degree of muscle activation measured in micro volts (uV) will be recorded.

    Secondary Outcome Measures

    Date of birth
    It will be registered at the beginning of the study in order to calculate the age of the participant.
    Sex
    It will be registered at the beginning of the study.
    Height
    It will be registered at the beginning of the study in centimeters.
    Weight
    It will be registered at the beginning of the study in centimeters.

    Full Information

    First Posted
    March 9, 2023
    Last Updated
    March 23, 2023
    Sponsor
    University of Salamanca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05785962
    Brief Title
    Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury.
    Acronym
    ElectroVojta
    Official Title
    Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Salamanca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A non-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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Muscles

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects in each group will be matched by age and sex.
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group for people with brain damage
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Intervention group for people without brain damage
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Vojta Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Electromyographic activity in abdominal muscles
    Description
    The electromyographic activity of internal and external obliques in nanovolts will be collected before, during and after the intervention. Acquired signals are sampled at 1 KHz and filtered with a 60 Hz high pass digital filter to reject signals of non-muscular origin. The degree of muscle activation measured in micro volts (uV) will be recorded.
    Time Frame
    Change from Baseline electromyographic activity at 10 minutes.
    Secondary Outcome Measure Information:
    Title
    Date of birth
    Description
    It will be registered at the beginning of the study in order to calculate the age of the participant.
    Time Frame
    Baseline
    Title
    Sex
    Description
    It will be registered at the beginning of the study.
    Time Frame
    Baseline
    Title
    Height
    Description
    It will be registered at the beginning of the study in centimeters.
    Time Frame
    Baseline
    Title
    Weight
    Description
    It will be registered at the beginning of the study in centimeters.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Brain injury group Inclusion Criteria : Over 18 and under 80 years of age Persons with a medical diagnosis of brain damage secondary to stroke Have preserved the ability to walk, even with some type of orthopedic some type of orthopedic aid, Exclusion Criteria: Over 80 years Healthy people Group without brain damage Inclusion Criteria : Over 18 and under 80 years of age Healthy people 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. Fever

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury.

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