Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Changes in Quality of Movement
研究概览
简要总结
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.
详细描述
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
- Angiogenesis
- Anti-inflammation.
On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral Palsy
- •Abnormal Muscle Tone
- •Abnormal Brain MRI
- •Willing to Comply with All Study Procedure
排除标准
- •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
研究组 & 干预措施
Erythropoietin and Rehabilitation
recombinant human erythropoietin injection and active rehabilitation
干预措施: Erythropoietin (Drug)
Placebo and Rehabilitation
Placebo erythropoietin and rehabilitation
干预措施: Placebo erythropoietin (Drug)
结局指标
主要结局
Changes in Quality of Movement
时间窗: 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).
次要结局
- Changes in Motor Development(Baseline - 2 months)
- Changes in Spasticity(Baseline - 2 months)
- Changes in Gross Motor Function(Baseline - 2 months)
- Changes in Neurodevelopmental Outcomes(Baseline - 2 months)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital