- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02378987
The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis
10. marts 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
46
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 8 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
children with CP having language ability greater than 3 years
Beskrivelse
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.).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change of Peabody Picture Vocabulary Test-Revised
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of Percentage of Correct Consonant in six months
Tidsramme: baseline and six months
|
Children with CP underwent the assessments of Percentage of Correct Consonant
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baseline and six months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Chia-Ling Chen, PhD, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2010
Primær færdiggørelse (Faktiske)
1. juli 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
25. februar 2015
Først indsendt, der opfyldte QC-kriterier
2. marts 2015
Først opslået (Skøn)
4. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2015
Sidst verificeret
1. august 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 99-1917B
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