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Completed

NCT Number: NCT01903603

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)

Secondary outcomes

  1. Change from baseline of kinematic analysis in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Kinematic analysis for upper limb and gait analysis

  2. 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

    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).

  3. Change from baseline of movement and participation for CP in 6 months and 12 months

    Time frame: baseline, 6 months, 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.

  4. Change from baseline of severity for CP patients in 6 months and 12 months

    Time frame: baseline, 6 months, 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2013
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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