An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 6
- 主要终点
- Change from baseline on GMFM-66 scores at week 26 and 52
研究概览
简要总结
This study is designed to assess effectiveness, safety and cost-utility of conventional rehabilitation and traditional Korean medicine conjugated rehabilitation on children with cerebral palsy.
详细描述
-
Survey
-
An interview survey on baseline
- Basic characteristics
- Cause of cerebral palsy
- Accompanied disorders
- Health problems
- Operation history
- Drug-taking
- Rehabilitation treatment
- Korean medicine treatment
- Health functional food
- Medical care cost
- An interview survey on 26th and 52nd weeks
- Accompanied disorders
- Health problems
- A weekly tracking survey
- Health problems
- Therapeutic change
- Medical care cost
- Quality of life
- Assessment for function development on baseline, 26th and 52nd weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 78 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with cerebral palsy
- •Age from 6 to 78 months
- •whose guardian consent to the present study
排除标准
- •who had an orthopedic operation due to cerebral palsy
- •who has congenital muscular disease, hereditary disease, or progressive central nervous system diseases
- •who suffers from severe diseases (ie, cancer, severe heart disease, severe infectious disease)
结局指标
主要结局
Change from baseline on GMFM-66 scores at week 26 and 52
时间窗: Baseline, Week 26, Week 52
The GMFM-66 includes 66 items identified through Rasch analysis, which, together, best describe gross motor function in children with cerebral palsy of varying abilities.
Change from baseline on PEDI scores at week 26 and 52
时间窗: Baseline, Week 26, Week 52
The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions.
次要结局
- Change of severity from baseline on accompanied disorders and health problems at week 24 and 52(Baseline, Week 26, Week 52)
研究者
Young Ju Yun
Associate Professor
Korean Medicine Hospital of Pusan National University