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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903603
• Other study ID #: 100-4545A3
• Secondary ID: NSC101-2314-B-18
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: September 7, 2017
• Start date: August 2012
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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