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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01948154
First received: September 5, 2013
Last updated: September 27, 2013
Last verified: February 2012
  Purpose

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).


Condition
Cerebral Palsy
Speech Function
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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 130
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
normal child 2-12 years old (50 subjects)

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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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. Botulium toxin-A injection within 3 months
  4. Concurrent progressive or degenerative diseases, peripheral neuropathy, spinal cord injury.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948154

Contacts
Contact: Katie P Wu, Medical Doctor +886-3-328-1200 ext 3846 katiewu1110@gmail.com
Contact: Chia-ling Chen, MD,PhD +886-3-328-1200 ext 8147 clingchen@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Katie P Wu, Medical Doctor    886-3-328-1200 ext 3846    katiewu1110@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01948154     History of Changes
Other Study ID Numbers: CMRPG3C1241
Study First Received: September 5, 2013
Last Updated: September 27, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Cerebral Palsy
Early Intervention
Speech Function
Quality of Life

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014