Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-26 @ 1:54 PM
Study NCT ID:
NCT03535467
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver Burden Inventory', 'timeFrame': '15 days', 'description': "Caregiver Burden Inventory(CBI) first designed by Novak and Guest in 1989 to measure burden of patient's caregiver. Caregiver can be a relative or a professional. CBI consists of 5 different subscales(Time Dependency Items(5 question),Development Items(5 question),Physical Health Items(4 question),Emotional Health Items(5 question),Social Relationship Items(5 question)), a total of 24 questions. Every question should be answered by the caregiver according to a likert scale (0=Never,1=Rarely,2=Sometimes,3=Quite Frequently,4=Nearly Always) and a total of 96 points. 36 point is a limit to a professional help for caregiver and the higher the points get there is more burden for caregiver."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregivers', 'Exoskeleton Device', 'Stroke Rehabilitation'], 'conditions': ['Stroke Rehabilitation and Caregivers']}, 'referencesModule': {'references': [{'pmid': '32776169', 'type': 'DERIVED', 'citation': 'Guler MA, Erhan B, Yilmaz Yalcinkaya E. Caregiver burden in stroke inpatients: a randomized study comparing robot-assisted gait training and conventional therapy. Acta Neurol Belg. 2021 Jun;121(3):729-736. doi: 10.1007/s13760-020-01465-5. Epub 2020 Aug 10.'}]}, 'descriptionModule': {'briefSummary': "Caregiver's burden in rehabilitation is important for both patients physical and mental health. Therefore researching caregivers burden and treatment of any depression or associated any psychological disorders of caregiver is crucial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,\n\nExclusion Criteria:\n\n* More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation'}, 'identificationModule': {'nctId': 'NCT03535467', 'briefTitle': 'Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation', 'orgStudyIdInfo': {'id': 'GaziosmanpasaTREH1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional Rehabilitation', 'interventionNames': ["Other: Caregiver's Burden Inventory"]}, {'label': 'Robotic Therapy', 'interventionNames': ["Other: Caregiver's Burden Inventory"]}], 'interventions': [{'name': "Caregiver's Burden Inventory", 'type': 'OTHER', 'description': 'The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.', 'armGroupLabels': ['Conventional Rehabilitation', 'Robotic Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa Taksim Research and Education Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Akif GÜLER', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}