Therapeutic Effects of Individualized Educational Training on Preschool Children With Global Developmental Delay
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- changes of attention
研究概览
简要总结
Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays.
详细描述
A total of 20 preschool children with developmental delay who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with individualized educational training: one time per week, 50 min per session, with a total of 4 sessions in one month) and the control group (traditional rehabilitation program without individualized educational training).
Therapeutic effects, including pediatric daily activity, attention, cognitive function, functional performance, quality of life, and physical functional performance at baseline, after one month of treatment, and 3 months after the treatment, will be evaluated.
The evaluators will be blinded to the group's allocation during the whole course of the intervention.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes measurements will be performed by researchers who are blind to the groups' allocation.
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preschool children with a diagnosis of developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
排除标准
- •age less than 3 or greater than 6 of children diagnosed with developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
结局指标
主要结局
changes of attention
时间窗: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Conners Kiddie Continous Performance Test, 2nd edition
changes of daily activity
时间窗: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Pediatric Daily Occupation Scale
次要结局
- changes of family impact(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- changes of chair climbing speed(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- change of visual motor integration(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- changes of walking speed(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- changes of balance and coordination(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- change of intelligence(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- Changes of functional performance(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- changes of quality of life(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- changes of balance(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
- changes of physical function(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)