Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
NCT ID: NCT01817816
Last Updated: 2015-11-05
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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COMPLETED
NA
80 participants
INTERVENTIONAL
2009-01-31
2015-06-30
Brief Summary
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This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Botox_A
receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)
Botox_A
placebo_A
receiving placebo injection at both aLE \& aUE ; receiving Botox-A at both aLE \& aUE at 6-month.
Botox_A
Botox_B
receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.
Botox_B
placebo_B
receiving placebo injection at both aLE \& aUE ; receiving Botox-A only at aLE at 6-month.
Botox_B
Interventions
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Botox_A
Botox_B
Eligibility Criteria
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Inclusion Criteria
* independent walking 10 meters (with assistive devices)
Exclusion Criteria
* lower limb fracture
* received anti-spasticity injection in the past
45 Years
75 Years
ALL
No
Sponsors
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Changhua Christian Hospital
OTHER
Responsible Party
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Ta-Sen Wei,MD
Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor
Locations
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Changhua Christian Hospital
Dawan, Changhua, Taiwan
Countries
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Other Identifiers
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CCH-061203
Identifier Type: -
Identifier Source: org_study_id
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