search
Back to results

Effect of Vojta Therapy on Covid-19 Respiratory Disease

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Respiratory physiotherapy
Sponsored by
NUMEN Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring Vojta therapy, Respiratory physiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • respiratory disease by covid-19

Exclusion Criteria:

  • patient older than 75 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vojta Therapy

    Control Group

    Arm Description

    Reflex turn first phase: Patient positioned supine with legs flexed 30º-45º. The pectoral area is stimulated for five minutes on each side x 2 consecutive times. Total 20 minutes per session.

    .Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants

    Outcomes

    Primary Outcome Measures

    SpO2
    Oxygen saturation
    Breathing frequency
    frequency of respiratory cycles per minute
    Stay time
    Days of stay in the intermediate respiratory care unit

    Secondary Outcome Measures

    Full Information

    First Posted
    August 28, 2021
    Last Updated
    August 30, 2021
    Sponsor
    NUMEN Foundation
    Collaborators
    Hospital de Emergencias Enfermera Isabel Zendal de Madrid
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05031858
    Brief Title
    Effect of Vojta Therapy on Covid-19 Respiratory Disease
    Official Title
    Effect of Vojta Therapy in Respiratory Disease Caused by SARS-CoV-2. Randomized Controlled Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 25, 2021 (Anticipated)
    Primary Completion Date
    December 20, 2021 (Anticipated)
    Study Completion Date
    April 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    NUMEN Foundation
    Collaborators
    Hospital de Emergencias Enfermera Isabel Zendal de Madrid

    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
    Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Acute Respiratory Distress Syndrome
    Keywords
    Vojta therapy, Respiratory physiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vojta Therapy
    Arm Type
    Experimental
    Arm Description
    Reflex turn first phase: Patient positioned supine with legs flexed 30º-45º. The pectoral area is stimulated for five minutes on each side x 2 consecutive times. Total 20 minutes per session.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    .Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants
    Intervention Type
    Other
    Intervention Name(s)
    Respiratory physiotherapy
    Intervention Description
    Respiratory physiotherapy
    Primary Outcome Measure Information:
    Title
    SpO2
    Description
    Oxygen saturation
    Time Frame
    3 weeks
    Title
    Breathing frequency
    Description
    frequency of respiratory cycles per minute
    Time Frame
    3 weeks
    Title
    Stay time
    Description
    Days of stay in the intermediate respiratory care unit
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: respiratory disease by covid-19 Exclusion Criteria: patient older than 75 years

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Vojta Therapy on Covid-19 Respiratory Disease

    We'll reach out to this number within 24 hrs