Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity
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ClinicalTrials.gov Identifier: NCT00723866 |
Recruitment Status
:
Completed
First Posted
: July 29, 2008
Last Update Posted
: August 1, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Other: BtxA+mCIMT Other: BtxA+ conventional rehabilitation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
BtxA+mCIMT (combination group)
|
Other: BtxA+mCIMT
The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
Other Name: the combination group
|
Placebo Comparator: 2
BtxA+ conventional rehabilitation (control group)
|
Other: BtxA+ conventional rehabilitation
The control group received for 2 hours/day, 3 days/week for 3 months.
Other Name: the control group
|
- The primary outcome assessed spasticity on the Modified Ashworth Scale. [ Time Frame: MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection. ]
- Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction. [ Time Frame: evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection. ]

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18 to 80 years
- at least 1 year after a unilateral stroke
- modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors
- ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).
Exclusion Criteria:
- presence of fixed joint contractures
- serious balance problems
- preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions
- significant cognitive deficits (Mini-Mental Status Examination score < 24)
- excessive pain in the affected upper limb
- previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity
All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723866
Principal Investigator: | Shu-Fen Sun, MD | Department of Physical Medicine and Rehabilitation |
Publications:
Responsible Party: | Kaohsiung Veterans General Hospital |
ClinicalTrials.gov Identifier: | NCT00723866 History of Changes |
Other Study ID Numbers: |
VGHKS94-087 |
First Posted: | July 29, 2008 Key Record Dates |
Last Update Posted: | August 1, 2008 |
Last Verified: | July 2008 |
Keywords provided by Kaohsiung Veterans General Hospital.:
Botulinum toxin, Spasticity, Stroke, Rehabilitation. |
Additional relevant MeSH terms:
Stroke Muscle Spasticity Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations |
Signs and Symptoms Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |