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Completed

NCT Number: NCT01948154

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

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).

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up

    Time frame: baseline, 6 month, 12 month

    change of CDIIT

Secondary outcomes

  1. change of Mental Ability

    Time frame: baseline, 6 month, 12 month

    change of Mental Ability (BSID-II, WPPSI-R, WISC-IV)in 6 month, 12 month follow up

Other outcomes

  1. change of Motor Speech in 6 month, 12 month

    Time frame: baseline, 6 month,12 month

    Motor Speech Assessment (VMPAC, PCC)in 6 month, 12 month follow up

  2. Language Assessment

    Time frame: baseline, 6 month, 12 month

    Language Assessment (PPVT-R; CLST)in 6 month, 12 month follow up

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 23, 2013
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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