NCT02378987

Brief Summary

The aims of this study:

  1. 1.to investigate the difference in motor speech functions among children with cerebral palsy (CP) of different motor severities.
  2. 2.to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with CP of different motor severities.
  3. 3.the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with CP.
  4. 4.to identify the variables that can predict motor speech functions in children with CP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
Last Updated

March 11, 2015

Status Verified

August 1, 2010

Enrollment Period

1.8 years

First QC Date

February 25, 2015

Last Update Submit

March 10, 2015

Conditions

Keywords

cerebral palsylanguageacousticmotor speechfollow-up

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Change of Percentage of Correct Consonant in six months

    baseline and six months

Study Arms (3)

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).

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children with CP having language ability greater than 3 years

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral PalsyLanguage

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCommunicationBehavior

Study Officials

  • Chia-Ling Chen, PhD

    Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 4, 2015

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

March 11, 2015

Record last verified: 2010-08

Locations