Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 7:09 PM
Study NCT ID:
NCT05417802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2022-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveying Patient's Interest in Robotic Rehabilitation Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-08', 'size': 631977, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-27T16:13', 'hasProtocol': True}, {'date': '2021-12-08', 'size': 327547, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-05-27T16:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2022-06-05', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current Therapy question - 1', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'How many hours are you receiving occupational therapy for each session?'}, {'measure': 'Current Therapy question - 2', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'How frequent are you receiving therapy (ex.: 2/week: two times per week)?'}, {'measure': 'Current Therapy question - 3', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'When did you start your therapy (how many days after stroke)?'}, {'measure': 'Current Therapy question - 4', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'What kind of therapy are you receiving now?'}, {'measure': 'Current Therapy question - 5', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Do you think that the therapy you are receiving is helpful to restore your arm function and help you participate in activities during daily living (example: drinking, feeding, moving objects)?'}, {'measure': 'Current Therapy question - 6', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Do you think that you are receiving enough occupational therapy to help you participate in activities during daily living (example: drinking, feeding, moving objects)?'}, {'measure': 'Interest in Robotic Rehabilitation question - 1', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Do you think that this device can be helpful to improve your arm function from stroke?'}, {'measure': 'Interest in Robotic Rehabilitation question - 2', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Do you think that you will use the device for home training when it is provided?'}, {'measure': 'Interest in Robotic Rehabilitation question - 3', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Do you think that the device is helpful to help you participate in activities during daily living (example: drinking, feeding, moving objects)?'}, {'measure': 'Interest in Robotic Rehabilitation question - 4', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If you have the device at home, how long would you like to exercise with the device?'}, {'measure': 'Interest in Robotic Rehabilitation question - 5', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If you have the device at home, how frequent would like to use this device?'}, {'measure': 'Interest in Robotic Rehabilitation question - 6', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Do you think that the training can be more effective by adding virtual reality?'}, {'measure': 'Interest in Robotic Rehabilitation question - 7', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If the device can apply therapeutic force, which type of force do you prefer for home-training?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': "This is a survey study to understand the stroke survivor's interest in robotic training. Investigators will use a questionnaire and show a video of robotic therapy to ask questions on their interest.", 'detailedDescription': "The purpose of this research is to investigate the interest of individuals with recent stroke in robotic therapy. Investigators will introduce a novel robotic platform to train ADLs of stroke patients. Investigators will examine the usability of this device as a home trainer for training rotational hand manipulation tasks such as opening a pickle jar, turning a key, missing a pot with a ladle, etc. The device will especially target stroke patients with ischemic stroke to enhance the performance of ADL. Also, investigators will examine the frequency and dosage of the current occupational therapy, followed by the satisfaction of the current therapy. Participant's participation will contribute to the development of a new therapy method using a robotic device for home-based training."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with stroke\n* Adults with no cognitive difficulties\n\nExclusion Criteria:\n\n* Adults with pregnancy,\n* Adults with other neurological disorders than stroke\n* Adults with hemorrhagic stroke'}, 'identificationModule': {'nctId': 'NCT05417802', 'briefTitle': "Surveying Patient's Interest in Robotic Rehabilitation Device", 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': "Surveying Patient's Interest in Robotic Rehabilitation Device", 'orgStudyIdInfo': {'id': 'STUDY00004756'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke with acute stroke', 'description': "Inclusion criteria\n\n* Episode of single stroke within the past twelve weeks\n* Individuals' age over 18 years old.\n\nExclusion criteria\n\n* Pregnant women , neurological disorders other than stroke (i.e. Parkinson's), non-ischemic stroke\n* Individuals with severe cognitive impairments (demonstrating difficulty to understand, read, and answer the questions in writing)\n* Individuals with difficulties to listen the instruction and video of the robotic device"}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo General Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Jiyeon Kang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After the study is completed', 'ipdSharing': 'YES', 'description': 'The de-identified data will be shared upon request to PI.', 'accessCriteria': 'The personnel who is requesting the data needs to explain how the data will be used in their research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amit Kandel, MD, MBA', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}