A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy: a Combined Brain Imaging and Kinematic Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
研究概览
简要总结
The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) patients
详细描述
Cerebral palsy (CP) may lead to various motor deficits, which further influence the activities and participation. It would be ideal to characterize neural network and motor control model in patients with CP that underlies their clinical behavior by identifying altered neural network and motor control associated with behavioral improvement. The aim of this study is to investigate the brain image and motor control in patients with CP evaluated by multimodal imaging studies utilizing multi-modal techniques and kinematic analysis.
This study includes a prospective longitudinal study of patients with CP over one-year. This study will be executed in 3 phases within 3 years: 1st phase (1st years): to establish the multimodal brain images and motor control, and clinical outcomes protocol with a prospective one-year follow-up study in healthy subjects; 2nd phase (2nd years): to establish the brain images and motor control, and clinical outcomes with a prospective one-year follow-up study in older patients with CP; and 3rd phase (3rd years): to establish the brain images and motor control, and clinical outcomes with a prospective one-year follow-up study in younger patients with CP. In a prospective longitudinal study, each participant received 3-times measurements: at the beginning, 6 months later, and one year after the first data collection point
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
- 4 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Age: 4-20 y/o (2) Good cognition and cooperation (3) Healthy participants
排除标准
- •(1) Motor problems (2) Neurological, orthopedic, or progressive disorders (3) Active medical diseases, such as infection
结局指标
主要结局
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)
次要结局
- Change from baseline of kinematic analysis in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months(6 months and 12 months)
- Change from baseline of movement and participation for CP in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of severity for CP patients in 6 months and 12 months(baseline, 6 months, 12 months)