Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-07 @ 1:08 PM
Study NCT ID:
NCT00681434
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Training Versus Unilateral Training in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-01', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-19', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Assessment Scale', 'timeFrame': 'pre and post (week one and week 8)'}, {'measure': 'Motor Status Scale', 'timeFrame': 'pre and post, Week 0 and Week eight'}], 'secondaryOutcomes': [{'measure': 'Reaching Performance Scale', 'timeFrame': 'pre and post training (Week 0 and week 8)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'upper extremity', 'hemiparesis'], 'conditions': ['Stroke', 'Hemiparesis']}, 'referencesModule': {'references': [{'pmid': '19531608', 'type': 'RESULT', 'citation': 'Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.', 'detailedDescription': 'Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.\n\nThis training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cortical or subcortical stroke\n* chronic condition (at least six months prior)\n* ability to follow 2-step commands\n* ability to give consent\n\nExclusion Criteria:\n\n* lesion in brain stem or cerebellum\n* visual field cut\n* neglect\n* uncontrolled hypertension\n* angina\n* COPD'}, 'identificationModule': {'nctId': 'NCT00681434', 'briefTitle': 'Bilateral Training Versus Unilateral Training in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Bilateral Training for Upper Extremity Hemiparesis in Stroke', 'orgStudyIdInfo': {'id': '2006-0234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'bilateral training', 'interventionNames': ['Behavioral: bilateral upper extremity training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Unilateral training', 'interventionNames': ['Behavioral: Unilateral upper extremity training']}], 'interventions': [{'name': 'bilateral upper extremity training', 'type': 'BEHAVIORAL', 'description': 'Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.', 'armGroupLabels': ['1']}, {'name': 'Unilateral upper extremity training', 'type': 'BEHAVIORAL', 'description': 'Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mary E Stoykov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago Department of Kinesiology and Nutrition'}, {'name': 'Daniel M Corcos, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Illinois at Chicago Department of Kinesiology and Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Daniel M. Corcos, PhD', 'oldOrganization': 'University of Illinois at Chicago'}}}}