Clinical trial NCT01903603: A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy
Official title: A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy: a Combined Brain Imaging and Kinematic Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
multi-modal brain techniques
MRI
Kinematic
motor control
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CP and healthy children

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

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

Primary outcomes:
measure: Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline of kinematic analysis in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months
timeFrame: 6 months and 12 months
measure: Change from baseline of movement and participation for CP in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of severity for CP patients in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
name: Chia-Ling Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: