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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01903603
First received: July 17, 2013
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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


Condition
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy: a Combined Brain Imaging and Kinematic Analysis

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)


Secondary Outcome Measures:
  • Change from baseline of kinematic analysis in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Healthy children and CP: Bruininks- Oseretsky Test of Motor Proficiency II (BOT-2), WMFT, 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 [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    CP patients: Gross Motor Functional Classification System (GMFCS), Manual Ability Classification System (MACS), Modified Ashworth Scale (MAS), strength and endurance, selective control, etc


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Children
Inclusion criteria for healthy children were as follows: ages of 4-20 y/o ; good cognition and cooperation; and healthy children.
CP subjects
Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 4-20 years old.

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

Ages Eligible for Study:   4 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

CP and healthy children

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903603

Contacts
Contact: Chia-Ling Chen, PhD +886-3-3281200 ext 8147 clingchen@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, PhD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chia-Ling Chen, PhD Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01903603     History of Changes
Other Study ID Numbers: 100-4545A3, NSC101-2314-B-182-004-MY3
Study First Received: July 17, 2013
Last Updated: July 17, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
cerebral palsy
multi-modal brain techniques
MRI
Kinematic
motor control

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014