Erythropoietin Therapy for Children With Cerebral Palsy
Recruitment status was: Not yet recruiting
|Cerebral Palsy||Drug: Erythropoietin Drug: Placebo erythropoietin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind|
- 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
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650415
|Contact: Minyoung Kim, M.D., Ph.D.||email@example.com|
|Contact: Kyunghoon Min, M.D.||firstname.lastname@example.org|
|Korea, Republic of|
|CHA Bundang Medical Center, CHA University||Not yet recruiting|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712|
|Contact: Minyoung Kim, M.D., Ph.D. 82-31-780-1872 email@example.com|
|Contact: Kyunghoon Min, M.D. 82-10-8973-3732 firstname.lastname@example.org|
|Sub-Investigator: Kyunghoon Min, M.D.|
|Sub-Investigator: Junyoung Song, M.D.|
|Principal Investigator:||Minyoung Kim, M.D., Ph.D.||CHA University|