The Follow Study of Speech Functions in Preschool Childre... | NCT02378987

Studies
The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis

NCT02378987

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Mar 11, 2015Estimated

Enrollment

46Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Feb 25, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2015

Last Update Posted Date

Mar 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Peabody Picture Vocabulary Test-Revised	Children with CP underwent the assessments of Peabody Picture Vocabulary Test-Revised.	baseline and six months

Secondary Outcomes

Measure	Description	Time Frame
Change of Percentage of Correct Consonant in six months	Children with CP underwent the assessments of Percentage of Correct Consonant	baseline and six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

children with CP having language ability greater than 3 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chia-Ling Chen, PhD	Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital		Taoyuan		333	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D007802	Language

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided