Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
18. desember 2020 oppdatert av: Yannick Bleyenheuft, Université Catholique de Louvain
Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions.
Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
64
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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Brussels, Belgia, 1200
- Institute of Neuroscience, Université catholique de Louvain
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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
5 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- diagnosis of unilateral cerebral palsy
- MACS level I, II or III
- GMFCS level I, II, III
Exclusion Criteria:
- unstable seizure
- cognitive deficit that prevent understanding of simple games
- botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration 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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: control group
high/low dosage intervention, intensive or not (motor function rehabilitation)
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Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities.
50% of therapeutic time will be performed using the new interactive interface
Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles.
50% of therapeutic time will be performed using the new interactive interface
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Eksperimentell: interface group
high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)
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Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities.
50% of therapeutic time will be performed using the new interactive interface
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline Assisting Hand Assessments score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance.
This is a standardized criterion-referenced test.
It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner.
With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change from baseline Box and Blocks test score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Test measuring hand function through the number of blocks transported in 1 minute from one part an other of a box placed in front of the child.
Each hand tested separately
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measure of hand function/dexterity, through 7 activities simulating daily life activities.
Each hand is tested separately and time to complete each activity is reported using a stopwatch.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Modified Cooper test at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measurement of the stereognosis abilities.16
objects are placed in the hand and the child has to recognise the object only by touch.
both hands are tested separately and time to recognise the objects is reported using a stopwatch
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the upper extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the lower extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the upper extremities and lower extremities.
Only the self-care domain will be assessed here
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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The Canadian Occupational Performance Measure is a measure designed to capture the patient's self-perception of performance in everyday living, over time.
It consist of a semi-structured interview were the patient elicits daily life activities performed with difficulties (self-care, nutrition, transfer, household management, school, work, transport, leisure, etc).
Five activities are then chosen as the most important to improve and score on a 1 to 10 scale based on the actual patient's performance and satisfaction levels.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
Tidsramme: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Questionnaire measuring social participation
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Samarbeidspartnere og etterforskere
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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)
14. juni 2018
Primær fullføring (Faktiske)
20. juni 2020
Studiet fullført (Faktiske)
15. juli 2020
Datoer for studieregistrering
Først innsendt
21. juni 2018
Først innsendt som oppfylte QC-kriteriene
26. april 2019
Først lagt ut (Faktiske)
29. april 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B403201316810c
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