Cerebral PalsyNCT02378987
The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis
An observational study of Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aims of this study: 1. to investigate the difference in motor speech functions among children with cerebral palsy (CP) of different motor severities. 2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with CP of different motor severities. 3. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with CP having language ability greater than 3 years
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, language, acoustic, motor speech, follow-up
- Medical subject headings
- Cerebral Palsy, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Typical developmental children | Normal children | |
| 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). | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Peabody Picture Vocabulary Test-Revised
Children with CP underwent the assessments of Peabody Picture Vocabulary Test-Revised.
Measured: baseline and six months
Secondary outcomes (1)
Change of Percentage of Correct Consonant in six months
Children with CP underwent the assessments of Percentage of Correct Consonant
Measured: baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, PhD, Principal investigator, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378987
- Sponsor's protocol ID
- 99-1917B
- Status last verified
- Aug 2010
- First submitted
- 25 Feb 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis
- ClinicalTrials.gov ID
- NCT02378987
- Acronym / sponsor ID
- 99-1917B
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, language, acoustic, motor speech, follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Typical developmental children | – | –Normal children |
| 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). |
| 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). |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with CP having language ability greater than 3 years
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Peabody Picture Vocabulary Test-Revised
Time frame: baseline and six months
Children with CP underwent the assessments of Peabody Picture Vocabulary Test-Revised.
1 secondary outcome
Change of Percentage of Correct Consonant in six months
Time frame: baseline and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, PhD principal investigator
Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Peabody Picture Vocabulary Test-Revised (time frame: baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.