- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00469872
Focus on Function Study for Children With Cerebral Palsy
23. september 2014 opdateret af: Mary Law, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Family Centred Functional Therapy for Children With Cerebral Palsy
This study will compare two treatment approaches that are currently being used for children with cerebral palsy.
Both treatments aim to improve a child's function.
The two approaches being compared are: 1) improving function by working with the child to improve his/her skills and abilities ("child-focused" approach) and 2) improving function by changing/adapting the task and/or environment around the child to improve his/her skills and abilities ("context-focused" approach).
It is hypothesized that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Children with cerebral palsy commonly receive ongoing physical and occupational therapy to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure.
The primary objective of this project is to conduct a multi-site clinical trial to evaluate the efficacy of a context-focused approach in improving performance of functional tasks, mobility, participation in everyday activities and quality of life in 220 children 12 months to 5 years of age who have cerebral palsy.
A randomized clinical trial research design will be used to examine the efficacy of the context-focused approach compared to a child-focused approach.
72 therapists in Ontario and Alberta will be randomly assigned to provide either context-focused or child-focused therapy.
Therapists in both groups will participate in a training workshop and expert consultants will be available to support the therapists throughout the study.
Children will receive either the context-focused or child-focused therapy intervention for a period of 6 months.
Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period.
Outcomes will be measured across the domains of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, spinal alignment), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment).
The children's range of motion will also be evaluated by an independent, trained evaluator at baseline, 3, 6, and 9 months.
We hypothesize that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
128
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2G4
- University of Alberta
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 1C7
- McMaster University
-
-
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
1 år til 5 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- children with cerebral palsy
- children classified as levels I-V on the Gross Motor Function Classification System
- children aged 12 months to 5 years, 11 months
Exclusion Criteria:
- children whose parents feel uncomfortable or unable to respond to interviews and questionnaires in English
- children with planned surgical or medication changes during the study period that may impact motor function
- parents and caregivers who state that they will not be able to comply with the treatment schedule
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Child Focused
Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to improve child functioning
|
|
|
Eksperimentel: Context Focused
Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to change the task or environment around a child
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
activities (performance of functional tasks, motor function)
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
body function and structure (range of motion)
Tidsramme: 6 months
|
6 months
|
|
particpation
Tidsramme: 6 months
|
6 months
|
|
parental empowerment
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mary Law, PhD, McMaster University
- Ledende efterforsker: Johanna Darrah, PhD, University of Alberta
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. juni 2006
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først indsendt
3. maj 2007
Først indsendt, der opfyldte QC-kriterier
3. maj 2007
Først opslået (Skøn)
7. maj 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01HD044444 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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