Clinical trial NCT01903616: A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan
Official title: A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-07-19
Enrollment: 172
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with cerebral palsy

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.

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.

Eligibility 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

Primary outcomes:
measure: Change of speech and acoustic variables in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
Secondary outcomes:
measure: Change of range of motion (ROM) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of Pediatric Berg Balance Scale (PBS) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of spinal Alignment and Range of Motion Measure(SARROM) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of modified ashworth scale(MAS) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of cerebral palsy quality of life (CPQOL) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of TNO-AZL Preschool children Quality of Life (TAPQOL)in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of Children Assessment of Participation and Enjoyment (CAPE) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
measure: Change of Gross motor function measure (GMFM) in 6, 12 and 24 months
timeFrame: baseline, 6m, 12m, 24 m
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD,PhD
role: STUDY_CHAIR
References: