Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
18. december 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
64
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussels, Belgien, 1200
- Institute of Neuroscience, Université catholique de Louvain
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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
5 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
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Sponsor
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 (Faktiske)
14. juni 2018
Primær færdiggørelse (Faktiske)
20. juni 2020
Studieafslutning (Faktiske)
15. juli 2020
Datoer for studieregistrering
Først indsendt
21. juni 2018
Først indsendt, der opfyldte QC-kriterier
26. april 2019
Først opslået (Faktiske)
29. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B403201316810c
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