Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT00719433
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2008-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-19', 'studyFirstSubmitDate': '2008-07-17', 'studyFirstSubmitQcDate': '2008-07-18', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl Meyer Assessment Scale', 'timeFrame': 'four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up'}], 'secondaryOutcomes': [{'measure': 'Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning.', 'timeFrame': 'three and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up'}, {'measure': 'fMRI', 'timeFrame': 'before and after 8 weeks therapy, 2-months follow-up', 'description': 'in 20 Patients fMRI will be recorded while patients interact with an MR-compatible manipulandum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'chronic', 'rehabilitation', 'robot therapy', 'arm therapy'], 'conditions': ['Stroke', 'Upper Extremity Paresis']}, 'referencesModule': {'references': [{'pmid': '17674069', 'type': 'BACKGROUND', 'citation': 'Nef T, Mihelj M, Riener R. ARMin: a robot for patient-cooperative arm therapy. Med Biol Eng Comput. 2007 Sep;45(9):887-900. doi: 10.1007/s11517-007-0226-6. Epub 2007 Aug 3.'}, {'pmid': '27724916', 'type': 'DERIVED', 'citation': 'Valero-Cuevas FJ, Klamroth-Marganska V, Winstein CJ, Riener R. Robot-assisted and conventional therapies produce distinct rehabilitative trends in stroke survivors. J Neuroeng Rehabil. 2016 Oct 11;13(1):92. doi: 10.1186/s12984-016-0199-5.'}, {'pmid': '24382580', 'type': 'DERIVED', 'citation': 'Klamroth-Marganska V, Blanco J, Campen K, Curt A, Dietz V, Ettlin T, Felder M, Fellinghauer B, Guidali M, Kollmar A, Luft A, Nef T, Schuster-Amft C, Stahel W, Riener R. Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial. Lancet Neurol. 2014 Feb;13(2):159-66. doi: 10.1016/S1474-4422(13)70305-3. Epub 2013 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in chronic hemiparetic stroke patients.', 'detailedDescription': 'Robotic therapy will be performed with ARMin, which is a robotic arm exoskeleton that permits 3D movements of both proximal and distal arm joints. Combined with an audiovisual display, this device allows virtual training of Activities of Daily Living (ADL) and therapeutic gaming. A patient-responsive controller enables the assistance of the device only as needed. Chronic stroke patients (\\>6 months post stroke) will be randomly assigned to either an experimental or a control group. The experimental group will perform task-related intensive therapy with the support of ARMin. Therapists will treat the patients of the control group with standard motor relearning therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or more\n* first-ever stroke (hemorrhagic or ischemic), verified by brain imaging\n* stroke more than six months prior to the study\n* termination of conventional therapy and stable recovery stage (outpatients)\n* moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)\n* ability to sit in a chair without any additional support and without leaning on the back rest\n* written informed consent signed by the subject (or an authorized representative)\n\nExclusion Criteria:\n\n* Excessive spasticity of the affected arm (mAS ≥ 3)\n* any serious medical or psychiatric illness\n* participation in any clinical investigation within 4 weeks prior to the start of this study\n* anticipated need for any major surgery during the study\n* women known to be pregnant or lactating\n* Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity\n* shoulder subluxation (palpatory \\> 2 fingers)\n* diseased or damaged skin at the paralyzed arm\n* inability to communicate effectively with the neurological examiner such that the validity of the patient\'s data could be compromised\n* cyber sickness\n* pace-maker or other implanted electric devices\n* body weight \\> 120kg\n* serious cognitive deficits and aphasia preventing the performance of the ARMin treatment\n* participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.'}, 'identificationModule': {'nctId': 'NCT00719433', 'briefTitle': 'Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy', 'orgStudyIdInfo': {'id': 'SNF ARMin III -1'}, 'secondaryIdInfos': [{'id': 'SNF 325200-120621'}, {'id': 'EK-39/2007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: robot therapy (ARMin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Other: conventional therapy']}], 'interventions': [{'name': 'robot therapy (ARMin)', 'type': 'DEVICE', 'description': 'therapy of the affected arm with a robot for eight weeks, three times weekly for one hour', 'armGroupLabels': ['1']}, {'name': 'conventional therapy', 'type': 'OTHER', 'description': 'physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Balgrist', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Robert Riener, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sensory Motor Systems Lab, ETH Zürich'}, {'name': 'Armin Curt, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sensory Motor Systems Lab, ETH Zurich', 'class': 'UNKNOWN'}, {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, {'name': 'Reha Rheinfelden', 'class': 'OTHER'}, {'name': 'Zuercher Hoehenklinik Wald', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}