Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-03-04 @ 12:44 AM
Study NCT ID:
NCT02098135
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2014-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D013119', 'term': 'Spinal Cord 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of participant which can perform the ArmeoSenso - training.', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'Improvement in the Arm function', 'timeFrame': '42 days', 'description': 'WMFT (Wolf Motor Function Test), FMA-UL (Fugl-Meyer Assessment - Upper Limb), GRASSP (Graded and Redefined Assessment of Strength, Sensibility and Prehension)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '27515583', 'type': 'DERIVED', 'citation': 'Wittmann F, Held JP, Lambercy O, Starkey ML, Curt A, Hover R, Gassert R, Luft AR, Gonzenbach RR. Self-directed arm therapy at home after stroke with a sensor-based virtual reality training system. J Neuroeng Rehabil. 2016 Aug 11;13(1):75. doi: 10.1186/s12984-016-0182-1.'}]}, 'descriptionModule': {'briefSummary': 'stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,\n\n* Trial with medical device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 18 years old\n* Stroke or spinal cord injury in prehistory\n* Motor deficits of the upper limb (s)\n* Lifting the paretic arm against gravity possible AND\n* Minimum amount of movement in the horizontal plane of 20 x 20 cm\n* Ability and willingness to participate in the study\n\nExclusion criteria:\n\n* Severe aphasia\n* Severe dementia\n* Severe depression\n* Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)'}, 'identificationModule': {'nctId': 'NCT02098135', 'briefTitle': 'ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Phase 1 Study of a Home Therapy and Assessment for Patients With Arm Impairments', 'orgStudyIdInfo': {'id': '2013-0182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ArmeoSenso', 'description': 'The ArmeoSenso system is an easy to set up and use upper limb rehabilitation system for the home environment. It consists of a motion capture system based on wearable sensors in combination with a personal computer as well as a therapy software that provides an ergonomic user interface, therapy games and automated assessments.', 'interventionNames': ['Device: ArmeoSenso']}], 'interventions': [{'name': 'ArmeoSenso', 'type': 'DEVICE', 'description': 'Virtual realty therapy with a touchscreen computer and movement sensors, over 42 days.', 'armGroupLabels': ['ArmeoSenso']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Divison of Neurology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Andreas Luft, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}