The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke
NCT ID: NCT02580838
Last Updated: 2022-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2015-08-31
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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early OnabotulinumtoxinA group
OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.
OnabotulinumtoxinA
Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.
late OnabotulinumtoxinA group
OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.
OnabotulinumtoxinA
Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.
no OnabotulinumtoxinA group
OnabotulinumtoxinA will not be injected for this group.
No interventions assigned to this group
Interventions
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OnabotulinumtoxinA
Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* spasticity develops after stroke
Exclusion Criteria
* concurrent use of anti-spasticity medications
* patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others
* patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)
* patients who are pregnant or may become pregnant at the time of the proposed injection
18 Years
80 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Principal Investigators
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Richard Lin
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Locations
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Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Richard Lin
Role: CONTACT
Facility Contacts
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Other Identifiers
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B-BR-102-032
Identifier Type: -
Identifier Source: org_study_id
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