The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study

Conditions
-----------------
Cerebral Palsy, Speech Function, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
1. Subjects (Patients selection): A.50 healthy subjects B.30-40 2-5y11m y/o CP subjects C.30-40 6-12 CP subjects (children with cerebral palsy) Inclusion Criteria: Inclusion Criteria: Parents or guardians who signed informed consent Age 6-12 year old Diagnosed to have cerebral palsy Exclusion Criteria: Concurrent medical condition (such as: seizure, infection) Surgery within 3 months Botulinum toxin-A injection within 3 months Concurrent progressive or degenerative diseases, peripheral neuropathy, spinal cord injury.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with CP<br>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<br>normal child 2-12 years old (50 subjects) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up | change of CDIIT | baseline, 6 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Mental Ability | change of Mental Ability (BSID-II, WPPSI-R, WISC-IV)in 6 month, 12 month follow up | baseline, 6 month, 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Early Intervention, Speech Function, Quality of Life