Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

25. august 2013 oppdatert av: Brian McCrindle, The Hospital for Sick Children
The purpose of this project is to investigate the feasibility of using a home-based, parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants who have had surgery for a complex heart defect.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Neurodevelopmental deficits are a common morbidity among children who receive surgical treatment for complex congenital heart defects in infancy. Over 40% of children with complex heart defects will have neurodevelopmental deficits that persist throughout childhood even after a successful surgical procedure in infancy1. These deficits are typically related to basic motor perceptual motor or visual motor skills. Problems integrating what is seen (visual perceptions) with body movement (motor skills) makes it difficult for children to participate in peer play and limits their ability to succeed in school, thereby having a significant impact on the child's quality of life.

Traditional, therapist-delivered rehabilitation programmes to address these delays in neurodevelopment have not previously been attempted. It would be difficult to provide direct rehabilitation programmes to these patients given that their defects are rare and few patients are located within the same geographical area. Home-based, parent-delivered rehabilitation programmes have previously been shown to be effective at improving the motor skills of school-age children with complex heart defects5. Since a home-based parent delivered model would enable the participation of infants regardless of geographic location, the feasibility of using such a model for delivering neurodevelopmental rehabilitation should be investigated.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 år til 2 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Families will be eligible to participate in this study if the child:

  • Had the arterial switch operation (for transposition of the great arteries) or has had a Glenn procedure (for functional single ventricle).
  • Is medically stable for normal infant activities.
  • Is between 12 and 24 months of age in January 2010.

Exclusion Criteria:

Families will be excluded from study participation if:

  • The child has a recognized syndrome or other disability affecting neurodevelopment.
  • The child has had a medical procedure in the 3 months preceding the baseline study assessment.
  • The cardiologist responsible for the child's care refuses to allow the child's participation.
  • The child performs substantially above age-appropriate developmental milestones during the initial assessment (in which case an intervention is unlikely to have a detectable additional benefit).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: All Subjects
A total of 20 children and their parents will be recruited for this study. Ten children will have had the Glenn procedure and 10 infants will have had the arterial switch operation.
Atferdsmessig: Home-based neurodevelopmental rehabilitation programme
Participation in the study will require the parent and child to attend two assessment visits in addition to completing a series of parent and infant activities on a daily basis throughout the 10-week intervention period. The parent-led activities will include activities such as walking with the child, stacking blocks, rolling a ball to the child, hiding a toy under a blanket for the child to find, encouraging the child to kick a rattle while the child is lying on his/her back, or crawling or rolling in different directions.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales
Tidsramme: Baseline and four months
The Peabody Development Motor Scale has demonstrated validity and reliability for children from birth to 5 years of age. Six subtests (reflexes, stationary, locomotion, object manipulation, grasping, visual-motor integration) yield gross, fine and total motor quotient scores.
Baseline and four months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parents opinion on the home-based neurodevelopmental rehabilitation programme
Tidsramme: at 4 months
During the final assessment, the researcher will interview the parent to obtain their perspective on delivering the study activities at home.
at 4 months
Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme
Tidsramme: at 4 months
Research students participating in this project will also be interviewed regarding their experiences and perceptions of guiding a home-based, parent-delivered rehabilitation programme.
at 4 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Hospital for Sick Children

Etterforskere

  • Hovedetterforsker: Brian McCrindle, MD, The Hospital for Sick Children, Toronto Canada

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2009

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

10. november 2010

Først innsendt som oppfylte QC-kriteriene

10. november 2010

Først lagt ut (Anslag)

11. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 1000014278

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Hjertefeil

Kliniske studier på Home-based neurodevelopmental rehabilitation programme

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Serbia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere