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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy

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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CP and healthy children

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months	fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)	baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of movement and participation for CP in 6 months and 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.	baseline, 6 months, 12 months
Change from baseline of kinematic analysis in 6 months and 12 months	Kinematic analysis for upper limb and gait analysis	baseline, 6 months, 12 months
Change from baseline of severity for CP patients in 6 months and 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	baseline, 6 months, 12 months
Change from baseline of movement and participation for Healthy children and CP in 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).	6 months and 12 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chia-Ling Chen, PhD, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimate): July 19, 2013

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: MRI; cerebral palsy; motor control; Kinematic; multi-modal brain techniques
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 100-4545A3; NSC101-2314-B-182-004-MY3 (Other Identifier: National Science Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO