Spasticity as Sequela of Stroke Clinical Trial
Official title:
Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U
Seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be
recruited and randomly assigned to one of 5 groups. The groups are as followings.
Gp 1: placebo group (Normal saline 1.2 ml) Gp 2: Clostridium Botulinum Toxin Type A (Nabota,
DWP 450) 15 U Gp 3: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U Gp 4:
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U Gp 5: Clostridium Botulinum Toxin
Type A (Nabota, DWP 450) 70 U
According to the group, the injection will be performed to the finger flexor musles (flexor
digitorum superficialis and profundus). Outcome measurement will be MAS (Modified ashworth
scale), FMA, Wolf Motor Assessment, Cross sectional area measured by Ultrasonography.
Patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the
injection.
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