Skip to content

A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy

A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy: a Combined Brain Imaging and Kinematic Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01903603
Enrollment
80
Registered
2013-07-19
Start date
2012-08-31
Completion date
2017-06-30
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

cerebral palsy, multi-modal brain techniques, MRI, Kinematic, motor control

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

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 monthsbaseline, 6 months, 12 monthsfc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)

Secondary

MeasureTime frameDescription
Change from baseline of kinematic analysis in 6 months and 12 monthsbaseline, 6 months, 12 monthsKinematic analysis for upper limb and gait analysis
Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months6 months and 12 monthsHealthy 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 monthsbaseline, 6 months, 12 monthsMeasures 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 monthsbaseline, 6 months, 12 monthsCP patients: Gross Motor Functional Classification System (GMFCS), Manual Ability Classification System (MACS), Modified Ashworth Scale (MAS), strength and endurance, selective control, etc

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026