Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-14 @ 7:19 PM
Study NCT ID:
NCT02017093
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Error Enhancement of the Velocity Component
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ecarmeli@univ.haifa.ac.il', 'phone': '972-4-8288-397', 'title': 'Prof. Eli Carmeli', 'organization': 'University of Haifa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'There were no adverse events during the whole trial.', 'description': 'Adverse events for all the study participants, were monitored seperately for each of the participants, at the end of the last treatment session.\n\nAt the end of the study no adveres events were reported from any of investigators to the ethics committee of the rehabilitation institute.', 'eventGroups': [{'id': 'EG000', 'title': 'Error Enhancement', 'description': "Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.\n\nError Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement\n\nOptimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.", 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group: Traditional Therapy', 'description': "Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.\n\nError Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement\n\nOptimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.", 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Average Movement Trajectory Error From T1 to T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Error Enhancement', 'description': "Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.\n\nError Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement\n\nOptimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."}, {'id': 'OG001', 'title': 'Control Group: Traditional Therapy', 'description': "Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.\n\nError Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement\n\nOptimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."}], 'classes': [{'categories': [{'measurements': [{'value': '2.31', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).', 'description': 'While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fugl-Meyer Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Error Enhancement', 'description': 'Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.\n\nError Enhancement: Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.\n\ncontrol treatment: Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.'}], 'classes': [{'title': 'Fugl-Meyer score at T1', 'categories': [{'measurements': [{'value': '53.2', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '54.33', 'spread': '5.43', 'groupId': 'OG001'}]}]}, {'title': 'Fugl-Meyer score at T2', 'categories': [{'measurements': [{'value': '56.75', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '55.33', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).', 'description': 'The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Error Enhancement', 'description': "Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.\n\nError Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement\n\nOptimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."}, {'id': 'FG001', 'title': 'Control Group: Traditional Therapy', 'description': "Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.\n\nError Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement\n\nOptimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study', 'description': 'Patients admitted to rehabilitation center after a stroke.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients admitted to rehabilitation center after a stroke.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '57.33', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '59.14', 'spread': '9.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fugl-Meyer assessment score', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '3.26', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '5.43', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '4.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2013-06-20', 'resultsFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-09', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Average Movement Trajectory Error From T1 to T2', 'timeFrame': 'The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).', 'description': 'While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.'}, {'measure': 'Fugl-Meyer Assessment Score', 'timeFrame': 'The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).', 'description': 'The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CVA, rehabilitation'], 'conditions': ['Stroke', 'Hemiparesis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': "Givon-Mayo R, Simons E, Ohry A, Karpin H, Israely S, Carmeli E. A preliminary investigation of error enhancement of the velocity component in stroke patients' reaching movements. International Journal of Therapy and Rehabilitation. 2014;21(4):160-168."}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/16249912', 'label': 'Click here for more information about this study: http://www.ncbi.nlm.nih.gov/pubmed/18326055'}]}, 'descriptionModule': {'briefSummary': "The purpose of this pilot study was to explore the impact of enhancement of the velocity component error in the course of reaching movements of the impaired/hemiparetic limb in an acute stroke subject. We hypothesized that the method would shift velocity profiles toward the optimal, resulting in a reduction in error. A prototype robot. This robotic device system has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged to the subject's upper-limb in a sitting position.\n\nThe enhancement of the velocity component error would shift velocity profiles toward the optimal, resulting in a reduction in error.", 'detailedDescription': "The wrist of the subject is connected to the robotic arm by a strip which supports the arm but allows free movements of the wrist. This configuration allows subjects with impaired grasping ability to use the system. A bio-feedback system enables the subject to perform various functional motor tasks that are presented on the screen in front of him. The system's sensors detect motor errors or deviations from an optimal/proper movement trajectory or velocity profile. Any deviation in direction, velocity, acceleration or necessary force from the optimal trajectory results in applied robotic forces that enhance such errors/deviations. The sensors and the applied forces all work and compute in real time, so that the force measurements and the applied force are updated to the executed movement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single stroke\n* Two to three weeks post Stroke\n* Able to understand simple commands\n* Able to perform some reaching movements with the affected arm.\n* No other neurological, neuromuscular, orthopedic disorders and visual deficit\n\nExclusion Criteria:\n\n* Perceptual, apraxic, or major cognitive deficits,\n* Shoulder joint subluxation or pain in the upper-limb, and\n* Spasticity \\> 1 (single muscle Modified Ashworth Scale).'}, 'identificationModule': {'nctId': 'NCT02017093', 'briefTitle': 'Error Enhancement of the Velocity Component', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': "Error Enhancement of the Velocity Component in the Course of Stroke Patients' Reaching Movements - A Pilot Study", 'orgStudyIdInfo': {'id': 'UHaifa'}, 'secondaryIdInfos': [{'id': 'CEli', 'type': 'REGISTRY', 'domain': 'Eli Carmeli'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Error Enhancement', 'description': 'Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.', 'interventionNames': ['Device: Error Enhancement']}, {'type': 'EXPERIMENTAL', 'label': 'Control treatment', 'description': 'Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.', 'interventionNames': ['Device: control treatment']}], 'interventions': [{'name': 'Error Enhancement', 'type': 'DEVICE', 'otherNames': ['Experimental: Error Enhancement of the Velocity Component'], 'description': 'Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.', 'armGroupLabels': ['Error Enhancement']}, {'name': 'control treatment', 'type': 'DEVICE', 'description': 'Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.', 'armGroupLabels': ['Control treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Reuth Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Eli Carmeli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}, {'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Carmeli Eli', 'investigatorAffiliation': 'University of Haifa'}}}}