Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
18 décembre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
64
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Brussels, Belgique, 1200
- Institute of Neuroscience, Université catholique de Louvain
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
5 ans à 18 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline Assisting Hand Assessments score at 1 week post-camp
Délai: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
|
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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline Box and Blocks test score at 1 week post-camp
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 juin 2018
Achèvement primaire (Réel)
20 juin 2020
Achèvement de l'étude (Réel)
15 juillet 2020
Dates d'inscription aux études
Première soumission
21 juin 2018
Première soumission répondant aux critères de contrôle qualité
26 avril 2019
Première publication (Réel)
29 avril 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 décembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 décembre 2020
Dernière vérification
1 décembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B403201316810c
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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