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NCT Number: NCT01903616

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

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.

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Key information

Conditions

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

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2013
Registry last updated
Aug 24, 2020

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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