Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT00723866
Status:
COMPLETED
Last Update Posted:
2008-08-01
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], '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': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-29', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome assessed spasticity on the Modified Ashworth Scale.', 'timeFrame': 'MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.'}], 'secondaryOutcomes': [{'measure': "Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.", 'timeFrame': 'evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Botulinum toxin, Spasticity, Stroke, Rehabilitation.'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '17012643', 'type': 'BACKGROUND', 'citation': 'Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Yang CL. Application of combined botulinum toxin type A and modified constraint-induced movement therapy for an individual with chronic upper-extremity spasticity after stroke. Phys Ther. 2006 Oct;86(10):1387-97. doi: 10.2522/ptj.20050262.'}]}, 'descriptionModule': {'briefSummary': 'Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.', 'detailedDescription': 'Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 80 years\n* at least 1 year after a unilateral stroke\n* modified ashworth scale (MAS) score \\> 3 in the elbow, wrist or finger flexors\n* ability to actively extend \\> 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).\n\nExclusion Criteria:\n\n* presence of fixed joint contractures\n* serious balance problems\n* preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions\n* significant cognitive deficits (Mini-Mental Status Examination score \\< 24)\n* excessive pain in the affected upper limb\n* previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity\n\nAll patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period'}, 'identificationModule': {'nctId': 'NCT00723866', 'briefTitle': 'Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity', 'orgStudyIdInfo': {'id': 'VGHKS94-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'BtxA+mCIMT (combination group)', 'interventionNames': ['Other: BtxA+mCIMT']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'BtxA+ conventional rehabilitation (control group)', 'interventionNames': ['Other: BtxA+ conventional rehabilitation']}], 'interventions': [{'name': 'BtxA+mCIMT', 'type': 'OTHER', 'otherNames': ['the combination group'], 'description': 'The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.', 'armGroupLabels': ['1']}, {'name': 'BtxA+ conventional rehabilitation', 'type': 'OTHER', 'otherNames': ['the control group'], 'description': 'The control group received for 2 hours/day, 3 days/week for 3 months.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shu-Fen Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine and Rehabilitation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kaohsiung Veterans General Hospital', 'oldOrganization': 'Kaohsiung Veterans General Hospital'}}}}