A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Registration Number
- NCT01903603
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- (1) Age: 4-20 y/o (2) Good cognition and cooperation (3) Healthy participants
- (1) Motor problems (2) Neurological, orthopedic, or progressive disorders (3) Active medical diseases, such as infection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months baseline, 6 months, 12 months fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)
- Secondary Outcome Measures
Name Time Method Change from baseline of kinematic analysis in 6 months and 12 months baseline, 6 months, 12 months Kinematic analysis for upper limb and gait analysis
Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months 6 months and 12 months Healthy children and CP: Bruininks- Oseretsky Test of Motor Proficiency II (BOT-2), Wolf Motor Function Test (WMFT), Block and Box test (BBT), Time up and go, Berg Balance Scale (BBS), Functional Independence Measure for Children (WeeFIM), Children Assessment of Participation and Enjoyment (CAPE), and School Function Assessment (SFA).
Change from baseline of movement and participation for CP in 6 months and 12 months baseline, 6 months, 12 months Measures for CP also include Gross motor function measure (GMFM), Quality of upper extremity test (QUEST), Pediatric Motor Activity Log (PMAL), Caregiver Functional Use Survey (CFUS), etc.
Change from baseline of severity for CP patients in 6 months and 12 months baseline, 6 months, 12 months CP patients: Gross Motor Functional Classification System (GMFCS), Manual Ability Classification System (MACS), Modified Ashworth Scale (MAS), strength and endurance, selective control, etc
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan