Clinical trial NCT01948154: The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study
Official title: The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Speech Function
Quality of Life
Keywords: Cerebral Palsy
Early Intervention
Speech Function
Quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will have children with CP (n=60\~80) and normal (n=50) from 2-12 years old under consent of their family.

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.

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:

1. Parents or guardians who signed informed consent
2. Age 6-12 year old
3. Diagnosed to have cerebral palsy

Exclusion Criteria:

1. Concurrent medical condition (such as: seizure, infection)
2. Surgery within 3 months
3. Botulinum toxin-A injection within 3 months
4. Concurrent progressive or degenerative diseases, peripheral neuropathy, spinal cord injury.

Primary outcomes:
measure: change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up
timeFrame: baseline, 6 month, 12 month
Secondary outcomes:
measure: change of Mental Ability
timeFrame: baseline, 6 month, 12 month
Other outcomes:
measure: change of Motor Speech in 6 month, 12 month
timeFrame: baseline, 6 month,12 month
measure: Language Assessment
timeFrame: baseline, 6 month, 12 month
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Katie P Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: