Erythropoietin Therapy for Children With Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT01650415|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Drug: Erythropoietin Drug: Placebo erythropoietin||Phase 2|
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;
- Neuroprotection effect
On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Erythropoietin and Rehabilitation
recombinant human erythropoietin injection and active rehabilitation
twice a week for 1 month
Other Name: Espogen
Placebo Comparator: Placebo and Rehabilitation
Placebo erythropoietin and rehabilitation
Drug: Placebo erythropoietin
twice a week for 1 month
- Changes in Quality of Movement [ Time Frame: Baseline - 2 months ]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).
- Changes in Gross Motor Function [ Time Frame: Baseline - 2 months ]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).
- Changes in Neurodevelopmental Outcomes [ Time Frame: Baseline - 2 months ]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).
- Changes in Motor Development [ Time Frame: Baseline - 2 months ]AIMS (Alberta Infant Motor Scale)to measure the motor development
- Changes in Spasticity [ Time Frame: Baseline - 2 months ]MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650415
|Korea, Republic of|
|CHA Bundang Medical Center, CHA University|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712|
|Principal Investigator:||Minyoung Kim, M.D., Ph.D.||CHA University|