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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, Dong Jak Ku, South Korea
RECRUITINGMAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Time frame: baseline
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Time frame: 2wks after injection
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Time frame: 4wks after injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Time frame: 8wks after injection
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Time frame: 12wks after injection
Ultrasonography
measurement of changes of cross sectional area
Time frame: baseline
Ultrasonography
measurement of changes of cross sectional area
Time frame: 2wks after injection
Ultrasonography
measurement of changes of cross sectional area
Time frame: 4wks after injection
Ultrasonography
measurement of changes of cross sectional area
Time frame: 8wks after injection
Ultrasonography
measurement of changes of cross sectional area
Time frame: 12wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Time frame: baseline
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Time frame: 2 wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Time frame: 4 wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Time frame: 8 wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Time frame: 12 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Time frame: baseline
Wolf Motor Assessment
measurement of upper extremity function
Time frame: 2 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Time frame: 4 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Time frame: 8 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Time frame: 12 wks after injection