- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07664878
AR-Based Motor Rehabilitation for Children With CP (PSYCHO-AR-REH)
25 juin 2026 mis à jour par: Rudolf Psotta, College of Physical Education and Sport PALESTRA
Digitalization of Rehabilitation Care for Children With Motor Disorders Using Augmented Reality Technologies
The aim of the project is to create a digital system for cognitive-oriented rehabilitation of the central neuromuscular diseases (CND) with the use of augmented reality (AR) technology in children.
Solving the project supports the professional-oriented digital literacy of professionals in rehabilitation institutions in the Czech Republic (CR).
With the applied research, the software will be developed for the training of fine and gross motor skills, postural control and walking in the AR environment for children with cerebral palsy and verified in the practice of professionals in rehabilitation.
The project aims to modernization and increase of the effectiveness of the work of professionals in rehabilitation institutions in the CR.
The project is based on an interdisciplinary approach.
Aperçu de l'étude
Statut
Inscription sur invitation
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
40
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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Prague, Tchéquie
- Palestra
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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
- Enfant
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Medical diagnosis of spastic hemiparesis or diparesis types cerebral palsy
- The level of motor skills was at levels I and II according to the Gross Motor Function Classification System (GMFCS)
- spasticity of grade 2 or less diagnosed with the Modified Ashworth Scale (MAS)
- Ability to walk at least 10 meters without aids and without the support of a therapist
Exclusion Criteria:
- no neurological disease other than CP
- no visual impairment with exception of short-sightedness
- Children is not able to follow instructions during testing and training
- Injection treatment of anti-spastic medication in the last 3 months
- Lower limb surgery within the past 12 months
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Groupe expérimental
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Traditional spa treatment comprising hydrotherapy and physical therapy.
The child wore Meta Quest 3 (Meta Platforms, Menlo Park, California, USA) VR/AR goggles during the exercises.
Our custom exercise applications were running on the device.
They provide brief verbal instructions at the start of each exercise.
During the exercise, they also give short cognitive prompts to support focused attention.
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Comparateur actif: Control group
conventional physical therapy program
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Traditional spa treatment comprising hydrotherapy and physical therapy.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Speed of 10-meter walk test (m/s)
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Speed (m/s): average speed of the walk 10 metres (10MWT)
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Cadence (steps/min)
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
Number of half-steps in one minute.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering)
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Support phase (% cycle)
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The average value of the durations of the right and left support phases as percentages of the duration of the gait cycle.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Swing Phase (% Cycle)
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The average value of the durations of the right and left swing phases as percentages of the duration of the gait cycle.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
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Symmetry index of pelvic tilt
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle.
Non-pathological subjects show an index greater than 90.
The pelvic tilt, is the sagittal component of 3D pelvic movement.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Symmetry index of pelvic obliquity
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle.
Non-pathological subjects show an index greater than 90.
The pelvic tilt, is the frontal component of 3D pelvic movement.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Symmetry index of pelvic rotation
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle.
Non-pathological subjects show an index greater than 90.
The pelvic tilt, is the transverse component of 3D pelvic movement.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
|
The Pediatric balance scale (PBS)
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The Pediatric Balance Scale is a modified version of the Berg Balance Scale.
The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Higher total scores suggest that the child has good balance ability.
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
One-Leg Balance (valuated by the time the child is able to maintain the position)
Délai: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
In this task, the child is asked to stand on one leg on a balance board or other unstable surface.
Each leg is tested separately.
The child must maintain balance for a maximum of 30 seconds.
The task is assessed in accordance with the MABC-2 manual.
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
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)
1 mars 2025
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
1 août 2026
Dates d'inscription aux études
Première soumission
11 mars 2026
Première soumission répondant aux critères de contrôle qualité
17 juin 2026
Première publication (Réel)
24 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TQ01000031
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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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