This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.
Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability. Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows; 1. Neuroprotection effect 2. Angiogenesis 3. Anti-inflammation. On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
twice a week for 1 month
twice a week for 1 month
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Changes in Quality of Movement
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones: alignment, coordination, dissociated movement, stability, and weight shift. The interrater reliability of GMPM subscores and total scores was 0.758-0.886 (subject n=75, tester n=10).
Time frame: Baseline - 2 months
Changes in Gross Motor Function
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of 6 sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping. The measured interrater reliability of GMFM subscores and total scores was 0.974 - 0.997 (subject n=101, tester n=10) and intrarater reliability of GMFM subscores and total scores between one most experienced rater and another newly t rained rater was 0.994 - 1.000 (subject n=101, tester n=2).
Time frame: Baseline - 2 months
Changes in Neurodevelopmental Outcomes
K-BSID-II (Korean version of Bayley Scale of Infant Development-II) Motor and Mental Scales. The measured intrarater and interrater reliability of K-BSID-II motor and mental scales was 0.92 - 0.99 (subject n=55, tester n=10).
Time frame: Baseline - 2 months
Changes in Motor Development
AIMS (Alberta Infant Motor Scale)to measure the motor development
Time frame: Baseline - 2 months
Changes in Spasticity
MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord
Time frame: Baseline - 2 months
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