NCT03534466终止不适用
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- step frequency
研究概览
简要总结
There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy. The aim of our study was to conduct early treadmill training in infants who were highly suspected of cerebral palsy and to follow up on their long-term gait development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 33W;
- •Correction of gestational age < 3 months;
- •It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.
- •There was no other therapeutic intervention before entering the study;
- •Informed consent is signed by the family.
排除标准
- •Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);
- •Brain damage caused by convulsion;
- •Metabolic brain damage caused by genetic defects;
- •Suffering from known severe congenital malformations;
- •Definite head trauma during labor or postpartum;
- •Peripheral neuromuscular disease or abnormal skeletal system.
结局指标
主要结局
step frequency
时间窗: The length of time from birth to the corrected age of 18 months
This variable is a number that records the infants' number of coordinated gaits in all gait training processes.
age of onset of independent walking
时间窗: The length of time from birth to the corrected age of 2 years
This variable is a gait parameter, recording a point in time the baby will start walking independently.
次要结局
- age of onset of walking with assistance(The length of time from birth to the corrected age of 2 years)
- step length(The length of time from birth to the corrected age of 18 months)
- gait double-limb support(The length of time from birth to the corrected age of 18 months)
- step width(The length of time from birth to the corrected age of 18 months)
- gait ankle plantar flexion(The length of time from birth to the corrected age of 18 months)
- toe-off(The length of time from birth to the corrected age of 18 months)
- gait ankle dorsiflexion(The length of time from birth to the corrected age of 18 months)
研究者
研究点 (1)
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