Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903616
Recruitment Status : Recruiting
First Posted : July 19, 2013
Last Update Posted : December 14, 2018
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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.

Condition or disease
Cerebral Palsy

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan
Study Start Date : July 2009
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change of range of motion (ROM) in 6, 12 and 24 months [ Time Frame: baseline, 6m, 12m, 24 m ]
    Measurement of ROM

  2. Change of Pediatric Berg Balance Scale (PBS) in 6, 12 and 24 months [ Time Frame: baseline, 6m, 12m, 24 m ]
    Measurement of PBS

  3. 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

  4. Change of modified ashworth scale(MAS) in 6, 12 and 24 months [ Time Frame: baseline, 6m, 12m, 24 m ]
    Measurement of MAS

  5. Change of cerebral palsy quality of life (CPQOL) in 6, 12 and 24 months [ Time Frame: baseline, 6m, 12m, 24 m ]
    Measurement of CPQOL

  6. 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

  7. 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

  8. Change of Gross motor function measure (GMFM) in 6, 12 and 24 months [ Time Frame: baseline, 6m, 12m, 24 m ]
    Measurement of GMFM



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with cerebral palsy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903616


Contacts
Layout table for location contacts
Contact: Chai-Ling Chen, MD, PhD +886-3-3281200 ext 8147 clingchen@gmail.com

Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, PHD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Layout table for investigator information
Study Chair: Chia-Ling Chen, MD,PhD Chang Gung Memorial Hospital

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01903616     History of Changes
Other Study ID Numbers: NSC 98-2314-B-182-006-MY3
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases