Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT05031858
Status:
UNKNOWN
Last Update Posted:
2021-09-02
First Post:
2021-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vojta Therapy on Covid-19 Respiratory Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2021-08-28', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2', 'timeFrame': '3 weeks', 'description': 'Oxygen saturation'}, {'measure': 'Breathing frequency', 'timeFrame': '3 weeks', 'description': 'frequency of respiratory cycles per minute'}, {'measure': 'Stay time', 'timeFrame': '3 weeks', 'description': 'Days of stay in the intermediate respiratory care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vojta therapy', 'Respiratory physiotherapy'], 'conditions': ['COVID-19 Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* respiratory disease by covid-19\n\nExclusion Criteria:\n\n* patient older than 75 years'}, 'identificationModule': {'nctId': 'NCT05031858', 'briefTitle': 'Effect of Vojta Therapy on Covid-19 Respiratory Disease', 'organization': {'class': 'OTHER', 'fullName': 'NUMEN Foundation'}, 'officialTitle': 'Effect of Vojta Therapy in Respiratory Disease Caused by SARS-CoV-2. Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'Numen3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vojta Therapy', '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.', 'interventionNames': ['Other: Respiratory physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': '.Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants', 'interventionNames': ['Other: Respiratory physiotherapy']}], 'interventions': [{'name': 'Respiratory physiotherapy', 'type': 'OTHER', 'description': 'Respiratory physiotherapy', 'armGroupLabels': ['Control Group', 'Vojta Therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NUMEN Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Emergencias Enfermera Isabel Zendal de Madrid', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Luis Perales Lopez', 'investigatorAffiliation': 'NUMEN Foundation'}}}}