A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy: a Combined Brain Imaging and Kinematic Analysis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1) Age: 4-20 y/o (2) Good cognition and cooperation (3) Healthy participants
Exclusion Criteria
- •(1) Motor problems (2) Neurological, orthopedic, or progressive disorders (3) Active medical diseases, such as infection
Outcomes
Primary Outcomes
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
Time Frame: baseline, 6 months, 12 months
fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)
Secondary Outcomes
- 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)