Intensive Goal Training for Adolescents With Cerebral Palsy
12. februar 2019 oppdatert av: MARINA B BRANDAO, Federal University of Minas Gerais
Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy
Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities.
The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP.
He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.
Studieoversikt
Detaljert beskrivelse
We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP.
Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks.
Moreover, they will be asked to daily practice these activities at home along the intervention period.
Studietype
Intervensjonell
Registrering (Forventet)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil
- Rekruttering
- Associação Mineira de Reabilitação
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Ta kontakt med:
- Priscilla B Figueiredo
- Telefonnummer: 3198839646
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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
8 år til 13 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Medical diagnosis of bilateral CP;
- Age between 12 and 17 years old;
- Manual Ability Classification System (MACS) ranging from levels I to III;
- Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;
- Ability to understand verbal instructions.
Exclusion Criteria:
- Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention group
Intensive goal training of relevant activities reported by adolescents in the beginning of the study.
Therapists will grade the level of complexity of the proposed activities, considering the relevant movements, task demands and contextual factors involved in the performance of each task.
Adolescents will be asked to practice these activities at home (1 hour/daily) and to discuss their difficulties and improvements with the therapists.
The intervention will be provided in a day-camp model.
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Intensive goal training : 30 hours during 2 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Functional Goals
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Daily functioning- Self-Care
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Daily functioning- Mobility
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Manual dexterity
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Gross motor function
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Gross Motor Function Measure (GMFM): gross motor function abilities assessed in activities from 5 domains: lying and rolling; seating; crawling and kneeling; standing; walking, running and jumping.
higher scores, better outcome
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Participation at home
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Participation Environment Measure: Children and Youth (PEM-CY): Structured questionnaire to assess the frequency and level of involvement in daily living tasks (home scale will be used) higher scores, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Participation in household activities
Tidsramme: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Children´s Helping Out: Responsibility, Expectations and Supports (CHORES): structured questionnaire to assess the frequency and level of assistance in household activities: higher scores, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
- de Brito Brandao M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622.
- Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30.
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 (Faktiske)
2. juni 2018
Primær fullføring (Forventet)
30. juni 2019
Studiet fullført (Forventet)
30. juni 2019
Datoer for studieregistrering
Først innsendt
26. april 2018
Først innsendt som oppfylte QC-kriteriene
8. mai 2018
Først lagt ut (Faktiske)
21. mai 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 54597916.1.0000.5149
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .