Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-27 @ 1:16 AM
Study NCT ID:
NCT03578250
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Error Augmentation Training Post Stroke
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment Scale', 'timeFrame': 'Baseline', 'description': 'Clinical test for the assessment of motor impairments of the upper extremity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Error augmentation', 'Rehabilitation', 'Cerebellum', 'Motor learning', 'Adaptation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke.\n\nThe aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke.\n\nFifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field.\n\nMotor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.', 'detailedDescription': 'Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke.\n\nThe aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke.\n\nFifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field.\n\nMotor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cortical stroke, unilateral hemiparesis\n\nExclusion Criteria:\n\n* other neurological disorders (Alzheimer's disease, PD), complete plegia,unilateral neglect,sensory aphasia, Mini Mental State Examination\\<20"}, 'identificationModule': {'nctId': 'NCT03578250', 'briefTitle': 'Error Augmentation Training Post Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'Upper Extremity Training by Error Augmentation in Post-stroke Individuals', 'orgStudyIdInfo': {'id': 'UHaifa062018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Training of the upper extremity on a robotic device. Participants will carry out hand reaching movement for multiple directions in 3 dimensions, while grasping the robotic handle according to assignments given by the robotic device.\n\nDuring training the robotic device will apply error augmentation force-field to perturbate the arm of the participant away from the straight trajectory line.', 'interventionNames': ['Other: Robotic Training']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': "Training of the upper extremity on a robotic device. Participants will carry out hand reaching movement for multiple directions in 3 dimensions, while grasping the robotic handle according to assignments given by the robotic device.\n\nDuring training the robotic device will not apply any perturbations on the participant's arm.", 'interventionNames': ['Other: Robotic Training']}], 'interventions': [{'name': 'Robotic Training', 'type': 'OTHER', 'description': 'Upper extremity training on a robotic device with or without error augmentation force field.', 'armGroupLabels': ['Control group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nesher', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Oxana Zalsov, MD', 'role': 'CONTACT', 'email': 'oxana_za@bbalev.co.il', 'phone': '972-73-2377315'}], 'facility': 'Bait Balev', 'geoPoint': {'lat': 32.76622, 'lon': 35.04425}}], 'centralContacts': [{'name': 'Eli Carmeli, PhD', 'role': 'CONTACT', 'email': 'ecarmeli@univ.haifa.ac.il', 'phone': '972-04-8288397'}], 'overallOfficials': [{'name': 'Eli Carmeli, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}