Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT02189551
Status:
TERMINATED
Last Update Posted:
2018-08-15
First Post:
2014-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'an additional intervention, amendet to the study (3rd arm, not described here), has not received clearance by regulatory authorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lateral hip movement', 'timeFrame': '30 min training during day 1 (next session after inclusion)', 'description': 'during 30 min training with each device, lateral hip movements will be assessed'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'day 2 and 3', 'description': 'Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).'}, {'measure': 'Patient motivation', 'timeFrame': 'day 2 and 3', 'description': 'Patient motivation, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).'}]}, 'conditionsModule': {'conditions': ['Post Stroke Gait Training']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective).\n\nPrimary study endpoints will be a significantly higher rated patient comfort and or patient satisfaction using the new versions, compared with the established Lokomat. Furthermore, muscle activity and kinematic movement patterns will be expected to show more involved muscle groups and a walking pattern involving more degrees of freedom during use of the new version compared with the established Lokomat.\n\nExploratory endpoints will be a significantly stronger involvement of muscles needed for balance, more physiological walking patterns and more change on the lateral positioning of the feet due to training with the new version, compared with the established Lokomat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower extremity weakness due to stroke\n* minor functional impairment (MRC \\< 5)\n* ability and willingness to participate\n\nExclusion Criteria:\n\n* severe spasticity of the lower extremities\n* severe dementia\n* severe depression\n* any other contraindications against Lokomat training\n* body weight \\> 135 kg'}, 'identificationModule': {'nctId': 'NCT02189551', 'acronym': 'LOKOMAT', 'briefTitle': 'Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cereneo AG'}, 'orgStudyIdInfo': {'id': 'EKNZ: 2014-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lokomat Pro', 'description': 'gait robot established on the market', 'interventionNames': ['Behavioral: Gait training with Lokomat Pro']}, {'type': 'EXPERIMENTAL', 'label': 'Lokomat Pro FreeD', 'description': 'gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market', 'interventionNames': ['Behavioral: Gait training with Lokomat Pro FreeD']}], 'interventions': [{'name': 'Gait training with Lokomat Pro', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Lokomat Pro']}, {'name': 'Gait training with Lokomat Pro FreeD', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Lokomat Pro FreeD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6354', 'city': 'Vitznau', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Cereneo, Center For Rehabilitation and Neurology', 'geoPoint': {'lat': 47.01014, 'lon': 8.4842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cereneo AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Swiss Commission for Technology and Innovation', 'class': 'OTHER'}, {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, {'name': 'Hocoma AG', 'class': 'UNKNOWN'}, {'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}