A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan

August 21, 2020 updated by: Chang Gung Memorial Hospital
This study investigates the longitudinal course of developmental patterns in movement and participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan. Additionally, the predictors in the initial stage in determining the final developmental patterns in movement and participation in life activities MPLA of these children will be identified.

Study Overview

Status

Completed

Conditions

Detailed Description

Most researches investigated the longitudinal study of functions in adolescent or adult with CP, however, few researches investigate these functions in children with CP. Knowledge of these developmental patterns in movement and participation in life activities MPLA may be helpful in understanding, anticipating, and managing the problems of these children. We hypothesize that the course of developmental patterns in MPLA of young children with CP evolves with their age. This study investigates the longitudinal course of developmental patterns in MPLA of young children with CP in Taiwan. This study includes a validity and reliability study and a prospective longitudinal study of young children with CP over one-year. This study will be executed in 4 years and a validity and reliability study in the first year.

Study Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with cerebral palsy

Description

Inclusion Criteria:

  • diagnosis of CP

Exclusion Criteria:

  • presence of a progressive neurological disorder or a severe concurrent illness or disease not typically associated with CP, such as traumatic brain injury or active pneumonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of speech and acoustic variables in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of speech and acoustic variables
baseline, 6m, 12m, 24 m

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of range of motion (ROM) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of ROM
baseline, 6m, 12m, 24 m
Change of Pediatric Berg Balance Scale (PBS) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of PBS
baseline, 6m, 12m, 24 m
Change of spinal Alignment and Range of Motion Measure(SARROM) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of SARROM
baseline, 6m, 12m, 24 m
Change of modified ashworth scale(MAS) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of MAS
baseline, 6m, 12m, 24 m
Change of cerebral palsy quality of life (CPQOL) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of CPQOL
baseline, 6m, 12m, 24 m
Change of TNO-AZL Preschool children Quality of Life (TAPQOL)in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of TAPQOL
baseline, 6m, 12m, 24 m
Change of Children Assessment of Participation and Enjoyment (CAPE) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of CAPE
baseline, 6m, 12m, 24 m
Change of Gross motor function measure (GMFM) in 6, 12 and 24 months
Time Frame: baseline, 6m, 12m, 24 m
Measurement of GMFM
baseline, 6m, 12m, 24 m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Study Chair: Chia-Ling Chen, MD,PhD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

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)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC 98-2314-B-182-006-MY3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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