The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to Botox® reducing upper limb muscle tone in post stroke patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
186
IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone
The Catholic University of Korea Incheon St. Mary's hospital
Incheon, Incheon, South Korea
Seoul National University Hospital
Bundang, Kyunggi, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Chung Ang University Hospital
Seoul, Seoul, South Korea
The change in MAS(Modified Ashworth Scale) grade
The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone
Time frame: from baseline at week 4
The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor
Time frame: from baseline at week 4
The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor
Time frame: from baseline at week 8 and 12
The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target
Time frame: from baseline at week 4, 8, 12
Global assessment evaluated by investigator
Time frame: at week 4, 8, 12
Global assessment evaluated by patients
Time frame: at week 4, 8, 12
The change in carer burden on Caregiver Burden Scale evaluated by caregiver
Time frame: from baseline at week 4, 8, 12
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Gangnam Severance Hospital
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea