The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study
Quality of Life
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||3 Years|
|Official Title:||The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study|
- change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up [ Time Frame: baseline, 6 month, 12 month ] [ Designated as safety issue: No ]change of CDIIT
- change of Mental Ability [ Time Frame: baseline, 6 month, 12 month ] [ Designated as safety issue: No ]change of Mental Ability (BSID-II, WPPSI-R, WISC-IV)in 6 month, 12 month follow up
- change of Motor Speech in 6 month, 12 month [ Time Frame: baseline, 6 month,12 month ] [ Designated as safety issue: No ]Motor Speech Assessment (VMPAC, PCC)in 6 month, 12 month follow up
- Language Assessment [ Time Frame: baseline, 6 month, 12 month ] [ Designated as safety issue: No ]Language Assessment (PPVT-R; CLST)in 6 month, 12 month follow up
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
children with CP
Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. 2-12 years old (n=60-80)
normal child 2-12 years old (50 subjects)
Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).
The investigators study aim in this project include: (1) to find the differences in speech function in normal developed children and in children with CP with different severity; (2) the relationship between speech function and QoL in children with CP; (3) to seek the predictable factor involving motor speech function in children with CP from the framework of International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY).
This will be a 3-year longitudinal project recruiting 110-130 children in total. The investigators will have children with CP (n=60~80) and normal (n=50) from 2-12 years old under consent of their family. The investigator's study will be based on structure of ICF-CY. In the first year, basic clinical assessments including motor, mental, vocabulary, motor speech function, general development, and subjective questionnaires on adaptation, participation, development and quality of life will be collected. During the second to the third year, all measurements will be repeated in the end of 6- and 12-month to follow the performance of children with CP and those with normal development.
The anticipated outcomes of this study are: (1) to observe the longitudinal change of speech function and QoL in children with CP. (2) Using ICF-CY items in rehabilitation services to describe the speech function and participation of social life for children with CP. (3)To identify the influencing factors and predictors of motor speech function for children with CP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01948154
|Contact: Katie P Wu, MD||+886-3-328-1200 ext firstname.lastname@example.org|
|Contact: Chia-ling Chen, MD,PhD||+886-3-328-1200 ext email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Katie P Wu, MD 886-3-328-1200 ext 3846 firstname.lastname@example.org|
|Principal Investigator:||Katie P Wu, MD||Chang Gung Memorial Hospital|