Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia (MouvsupTCIHemi)
7 juin 2019 mis à jour par: Nantes University Hospital
Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program
In France, Cerebral Palsy (CP) affects 1 in 450 births.
It results from lesions of the brain, before, during, or shortly after birth.
These non-progressive lesions cause muscle impairments, responsible for activity limitations.
These muscle impairments include muscle stiffness, and muscle weakness.
Children with Unilateral CP (UCP) have these impairments on only one side of the body.
To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm.
The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy.
It is known using clinical tests that this therapy improves the overall motor function of the impaired arm.
However, the underlying mechanisms are yet unknown.
An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family.
The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP.
The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT.
To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders.
Results from this study will provide leads to optimize CIT.
Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Quantitative and objective evaluation of upper limb movements will take place in a motion analysis laboratory and will take place as follow:
- A clinical exam of the participant will be performed by the physician to collect maximal passive joint amplitudes with a goniometer and anatomical measures (length, circumference) of the upper limb.
- The participant will be equipped with surface electromyographic electrodes to measure the activation of his superficial muscles, and with retroreflective markers placed on anatomical landmarks of his thorax, shoulder, and arm, to measure upper limb kinematics with a 3D motion capture system composed of 8 VICON cameras.
- Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
The participant will be placed on a height adjustable bench, in the center of the laboratory. He will be asked to perform upper limb movements:
- A few movements not measured, to familiarize with the equipment;
- Recorded movements: a trial is composed of a few consecutive cycles of a movement such as elbow flexion-extension. A trial usually last about 10seconds. A few seconds-time of rest is imposed between each trial. The required movements are the following: elbow flexion-extension, elbow pronosupination, and "hand to mouth".
- Finally, the participant will be asked to lie down on an exam table and to rest relax, in order to measure the electromyographic signal of his muscles at rest.
Duration of the protocol is about 1h30, with less than 30seconds of effort, and a few minutes of performing simple upper limb movements.
Type d'étude
Interventionnel
Inscription (Réel)
28
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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Nantes, France, 46208
- CHU de Nantes
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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
6 ans à 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Participants (excluding healthy volunteers) must have hemiparesis.
- Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
- Participants must be enrolled in a health insurance plan.
Exclusion Criteria:
- Inability to understand or follow instructions during 1h30.
- Physical incapacity to carry out the requested movements
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: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: A: Healthy volunteers
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Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
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Autre: B: Patient with heamiplegia
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Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
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Autre: C: Patient with heamiplegia and constraint induced therapy
arm with constraint induced therapy (done before the protocol)
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Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Upper limb muscle activation envelopes
Délai: 5 weeks
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Muscle activation envelopes come from electromyographic signals of upper limb muscles.
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5 weeks
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kinematics during active movements
Délai: 5 weeks
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Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
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5 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
28 mars 2017
Achèvement primaire (Réel)
17 avril 2019
Achèvement de l'étude (Réel)
17 avril 2019
Dates d'inscription aux études
Première soumission
20 mars 2017
Première soumission répondant aux critères de contrôle qualité
28 mars 2017
Première publication (Réel)
4 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC15_0310
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .