Cerebral Palsy Clinical Trial
Official title:
Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
Verified date | October 2017 |
Source | Bundang CHA Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.
Status | Completed |
Enrollment | 11 |
Est. completion date | December 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Months to 4 Years |
Eligibility |
Inclusion Criteria: - Cerebral Palsy - Abnormal Muscle Tone - Abnormal Brain MRI - Willing to Comply with All Study Procedure Exclusion Criteria: - Known Genetic Disorder - Other Etiologies Contributing Developmental Delay - Coagulopathy - Initial high Erythropoietin level in Serum - Previous Erythropoietin Treatment before 3 months - Presence of Drug Hypersensitivity Related to the Study Remedy - Intractable Seizure Disorder - Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Bundang CHA Hospital | LG Life Sciences |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Baseline - 2 months | |
Secondary | 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). | Baseline - 2 months | |
Secondary | 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). | Baseline - 2 months | |
Secondary | Changes in Motor Development | AIMS (Alberta Infant Motor Scale)to measure the motor development | Baseline - 2 months | |
Secondary | Changes in Spasticity | MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord | Baseline - 2 months |
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