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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948154
• Other study ID #: CMRPG3C1241
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: January 29, 2018
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Quality of Life
• Speech Function

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of Motor Speech in 6 month, 12 month	Motor Speech Assessment (VMPAC, PCC)in 6 month, 12 month follow up	baseline, 6 month,12 month
Other	Language Assessment	Language Assessment (PPVT-R; CLST)in 6 month, 12 month follow up	baseline, 6 month, 12 month
Primary	change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up	change of CDIIT	baseline, 6 month, 12 month
Secondary	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