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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903616
• Other study ID #: NSC 98-2314-B-182-006-MY3
• Status: Completed
• Start date: July 2009
• Est. completion date: August 2020

Study information

• Verified date: January 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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