A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Change from baseline of body function & structures in 6 months and 12 months
研究概览
简要总结
A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities
详细描述
Developmental Disabilities (DD) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. On the basis of International Classification of Functioning, Disability and Health -Children and Youth Version (ICF-CY) framework, problems related to Developmental Disabilities further limit activities of daily living (ADL) and participation of patients.
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
- 7 Days 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Developmental Disabilities
- •Age 0-25 y/o
- •Agree to sign informed consent
排除标准
- •Active medical condition (e.g. infection)
- •Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
- •Concurrent illness or disease not typically associated with DD (e.g. pneumonia)
结局指标
主要结局
Change from baseline of body function & structures in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Bruininks- Oseretsky Test of Motor Proficiency II
Change from baseline of upper extremity function & structures in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Quality of upper extremity skills test
Change from baseline of lower extremity function & structures in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Pediatric Balance Scale
Change from baseline of Sensory and Perceptual function in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Sensory Profile
Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Comprehensive Developmental Inventory for Infants and Toddlers
次要结局
- Change from baseline of Participation in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Personal & Environment factor in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of activities in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Quality of Life in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Rehabilitation & community service factor in 6 months and 12 months(baseline, 6 months, 12 months)