- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378987
The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis
March 10, 2015 updated by: Chang Gung Memorial Hospital
The aims of this study:
- to investigate the difference in motor speech functions among children with cerebral palsy (CP) of different motor severities.
- to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with CP of different motor severities.
- the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with CP.
- to identify the variables that can predict motor speech functions in children with CP.
Study Overview
Status
Completed
Conditions
Detailed Description
Mental impairment, language and speech disorders are the common associated problems in children with CP.
Previous studies focus on language and motor speech dysfunctions in children with CP at school-age child, adolescents and adults.
Few literatures identify the determinants for predicted the motor speech performance in these children.
It is important issue to follow-up the language and motor speech functions in children with CP.
These data will provide clinicians for outcome prediction and goal setting.The aims of this study: (1) to investigate the difference in motor speech functions among children with CP of different motor severities, and(2) to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with CP of different motor severities, and(3) the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with CP, and(4) to identify the variables that can predict motor speech functions in children with CP.
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
children with CP having language ability greater than 3 years
Description
Inclusion Criteria:
- Subjects between the ages of 4-8 years old children.
- Subjects which aged 7 years or older should sign a consent form by themself.
- In line with the assessment, the case must be able to follow simple verbal commands, and can be done in a simple sentence description.
- were diagnosed with spastic cerebral palsy.
Exclusion Criteria:
- physiological condition is unstable: Included in three months for surgery or infection and other major diseases
- there is progressive or degenerative symptoms or diseases (such as degenerative epilepsy), peripheral nerve injury, spinal cord injury.
- visual perception or hearing problems, after correction difficult communicators.
- other movement disorders patterns for children with cerebral palsy (athetoid type, offset type, etc.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Typical developmental children
Normal children
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CP children with GMFCS level I and II
Children with CP were classified into Levels I-II based on the Gross Motor Function Classification System (GMFCS).
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CP children with GMFCS level III and IV
Children with CP were classified into Levels III-IV based on the Gross Motor Function Classification System (GMFCS).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Peabody Picture Vocabulary Test-Revised
Time Frame: baseline and six months
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Children with CP underwent the assessments of Peabody Picture Vocabulary Test-Revised.
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baseline and six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Percentage of Correct Consonant in six months
Time Frame: baseline and six months
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Children with CP underwent the assessments of Percentage of Correct Consonant
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baseline and six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chia-Ling Chen, PhD, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
February 25, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
March 11, 2015
Last Update Submitted That Met QC Criteria
March 10, 2015
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-1917B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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