Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-29 @ 3:56 PM
Study NCT ID:
NCT02100592
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2014-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events during verticalization', 'timeFrame': '21 days: from T1 (first session) to T15 (last session)', 'description': 'It is a composite outcome, assessing the occurence of at least one of the following conditions (component outcomes):\n\nHeart rate \\<40 bpm or\\> 150 bpm; Mean arterial pressure \\<70 mmHg; Arterial oxygen saturation \\<90%; Onset of ECG anomalies; Traumatic dislodgement of a device;'}], 'secondaryOutcomes': [{'measure': 'Changes of hemodynamic parameters', 'timeFrame': '21 days: from T1 (first session) to T15 (last session)', 'description': 'Changes of hemodynamic parameters during each session and from T1 to T15; assessed parameters are:\n\nstroke volume; peripheral resistances; mean arterial pressure; cerebral perfusion pressure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brain injury', 'coma', 'intensive care', 'early rehabilitation'], 'conditions': ['Brain Injury']}, 'descriptionModule': {'briefSummary': 'Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.', 'detailedDescription': 'Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment\n2. Age between 18 and 75 years\n3. Glasgow Coma Scale ≤ 8 at entrance in ICUs\n4. Adequate respiratory exchange with PaO2/FiO2 ≥ 250\n5. Absence of sedation increased\n\nExclusion Criteria:\n\n1. Major chest trauma with multiple rib fractures and / or pneumothorax\n2. Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb\n3. Cardiovascular instability despite support with amines\n4. Intracranial pressure (ICP)\\> 25 mm / Hg\n5. Cerebral Perfusion Pressure (PPC) \\<60 mm / Hg\n6. Severe kidney failure requiring replacement therapy\n7. Decompensated liver disease\n8. Hematocrit value of ≤ 30%\n9. Body weight\\> 135 kg or height\\> 210 cm\n10. Deep vein thrombosis'}, 'identificationModule': {'nctId': 'NCT02100592', 'briefTitle': 'Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Generale Di Zona Moriggia-Pelascini'}, 'officialTitle': 'Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study', 'orgStudyIdInfo': {'id': 'ERIGO-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erigo treated', 'description': 'Early rehabilitation treatment on Erigo Hocoma, a tilt table with integrated stepping device within 3 - 30 days from injury', 'interventionNames': ['Other: Early rehabilitation treatment on Erigo Hocoma']}], 'interventions': [{'name': 'Early rehabilitation treatment on Erigo Hocoma', 'type': 'OTHER', 'description': '5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °', 'armGroupLabels': ['Erigo treated']}, {'name': 'Early rehabilitation treatment on Erigo Hocoma', 'type': 'OTHER', 'description': 'Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system', 'armGroupLabels': ['Erigo treated']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giuseppe Frazzitta, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Ospedale generale di zona 'Moriggia Pelascini'"}, {'name': 'Roberto Valsecchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ospedale generale di zona 'Moriggia Pelascini'"}, {'name': 'Leopold Saltuari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LDK Hochzirl'}, {'name': 'Luca Sebastianelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ospedale generale di zona 'Moriggia Pelascini'"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Generale Di Zona Moriggia-Pelascini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}