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Sponsored by: |
Kaohsiung Veterans General Hospital. |
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Information provided by: | Kaohsiung Veterans General Hospital. |
ClinicalTrials.gov Identifier: | NCT00723866 |
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.
Condition | Intervention |
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Stroke |
Other: BtxA+mCIMT Other: BtxA+ conventional rehabilitation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity |
Enrollment: | 32 |
Study Start Date: | December 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
BtxA+mCIMT (combination group)
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Other: BtxA+mCIMT
The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
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2: Placebo Comparator
BtxA+ conventional rehabilitation (control group)
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Other: BtxA+ conventional rehabilitation
The control group received for 2 hours/day, 3 days/week for 3 months.
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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.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period
Responsible Party: | Kaohsiung Veterans General Hospital ( Kaohsiung Veterans General Hospital ) |
Study ID Numbers: | VGHKS94-087 |
Study First Received: | July 25, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00723866 History of Changes |
Health Authority: | Taiwan: Institutional Review Board |
Botulinum toxin, Spasticity, Stroke, Rehabilitation. |
Muscle Spasticity Botulinum Toxins Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Peripheral Nervous System Agents Botulinum Toxin Type A Brain Diseases Cerebrovascular Disorders |
Anti-Dyskinesia Agents Stroke Nervous System Diseases Physiological Effects of Drugs Vascular Diseases Central Nervous System Diseases Neuromuscular Agents Brain Diseases |
Cerebrovascular Disorders Pharmacologic Actions Botulinum Toxins Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Botulinum Toxin Type A Central Nervous System Agents |