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

NCT ID: NCT01903603

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-06-30

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

Conditions

Cerebral Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Children

Inclusion criteria for healthy children were as follows: ages of 4-20 y/o ; good cognition and cooperation; and healthy children.

No interventions assigned to this group

CP subjects

Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 4-20 years old.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-Ling Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

NSC101-2314-B-182-004-MY3

Identifier Type: OTHER

Identifier Source: secondary_id

100-4545A3

Identifier Type: -

Identifier Source: org_study_id