Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02268266
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2014-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-10-15', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse event as a measure of safety and tolerability', 'timeFrame': 'Up to 8 hours', 'description': 'Control of cardiovascular parameters at desired ranges at healthy and at patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brain injury, early rehabilitation, tilt table'], 'conditions': ['Stroke', 'Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation).', 'detailedDescription': "In early rehabilitation of neurological patients, safe mobilization and intensive sensorimotor stimulation are key factors for therapeutic success. Early activation and stimulation of the patient intend enhancement of neuroplasticity and recovery. Furthermore, it improves the patient's communication and cooperation skills and counteracts secondary damages due to immobilization.\n\nThe study combines gradual verticalization during monitoring of vital parameters, with cyclic leg movement and foot loading. The table to ensures the necessary safety for the stabilization of the patient in the upright position. The patient stimulation is additionally enhanced by synchronized functional electrical stimulation (FES). By providing a safe solution for early mobilization, the Erigo counteracts the negative effects of immobility and accelerates the recovery process through intensive sensorimotor stimulation. It is the first choice therapy device for the early and safe mobilization of severely impaired, bed-ridden patients even in acute care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* minimum 18 years old\n* normal response to verbal instructions\n* oxygen saturation of the blood at least 92%\n* healthy german speaking men and women\n* non-smoker\n* heartbeat 40-100\n* systolic blood pressure 120 to 220 mmHg\n* in patients: post acute phase: stroke or other neurological functional disorder\n\nExclusion criteria:\n\n* severe contraction in the legs (Ashworth \\>3)\n* pregnancy\n* acute pain syndrome\n* severe cardio-pulmonary disease\n* history of orthostatic dysregulation\n* thrombophlebitis\n* diabetes\n* renal disease\n* contraindication for electric stimulation (instable epilepsy, cancer, pacemaker, palliative care)\n* weight \\> 120kg\n* height \\> 210 cm\n* skin lesions on legs'}, 'identificationModule': {'nctId': 'NCT02268266', 'acronym': 'ERIGO®LIFE', 'briefTitle': 'ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'ERIGO® Life - Study of Cardiovascular Parameters and Other Physiologic Parameters Under Verticalization and Simultaneous Mobilization of the Leg on Neurological Patients and Healthy Subjects', 'orgStudyIdInfo': {'id': 'ERIGO LIFE StV 22_2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single-arm study', 'description': 'Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects', 'interventionNames': ['Device: Erigo']}], 'interventions': [{'name': 'Erigo', 'type': 'DEVICE', 'otherNames': ['Erigo rehabilitation bed from Hocoma AG, Switzerland.'], 'description': 'The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation', 'armGroupLabels': ['Single-arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8636', 'city': 'Wald', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Zürcher Höhenklinik Wald', 'geoPoint': {'lat': 47.27595, 'lon': 8.91405}}, {'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Robert Riener, Prof.Dr.-Ing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Federal Institut of Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zuercher Hoehenklinik Wald', 'class': 'OTHER'}, {'name': 'Hocoma AG, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Verena Klamroth', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}