Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial.
Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap.
Aim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Saoussen Layouni, Associate professor
- Numéro de téléphone: 52785163
- E-mail: layouni.saoussen@FAMSO.u-sousse.tn
Lieux d'étude
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Sousse, Tunisie, 4000
- Department of PMR Sousse
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Contact:
- saoussen layouni
- Numéro de téléphone: 52785163
- E-mail: layouni.saoussen@FAMSO.u-sousse.tn
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.
- Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.
- Normal or corrected hearing and vision.
- Able to understand and follow simple directions and perform requested tasks.
- Tutor Consent.
Exclusion Criteria:
- Dizziness during VR sessions.
- Intolerance to VR environments.
- Unable to continue or follow the CIMT or VR program.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.
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All participants will undergo two assessment sessions, one at baseline and one at the end of the program. Clinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire. The clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation. After obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The Melbourne Assessment 2 (MA2)
Délai: before and immediately after the intervention
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The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks. It reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality. |
before and immediately after the intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Spasticity
Délai: before and immediately after intervention
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Spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist ranging from 0 (normal tone) to 4 (rigid). |
before and immediately after intervention
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Muscle strength
Délai: before and immediately after intervention
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Muscle strength grading (MRC) ranging from 0 (no muscle activation) to 5 (normal muscle strength with full power against maximal resistance and a complete range of motion). |
before and immediately after intervention
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Passive Range of Motion
Délai: before and immediately after intervention
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Upper limb passive range of motion (PROM) in degrees measured with a goniometer. |
before and immediately after intervention
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The Box and Blocks Test
Délai: before and immediately after intervention
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Unilateral gross manual dexterity (The Box and blocks Test) for the affected limb scored by counting the total number of blocks safely transferred from one compartment to the other in 60 seconds (number of blocks per minute). |
before and immediately after intervention
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ABILHANDS-KIDS questionnaire
Délai: before and immediately after intervention
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Bimanual ability to manage daily life activities through ABILHANDS-KIDS questionnaire ranging from 0 to 42, with each task is assessed as "easy", "difficult" or "impossible". Raw scores are converted through a psychometric analysis (Rasch model) into a linear measure in logits on a continuous scale. Higher score: Indicates a better manual ability and greater independence in daily life activities requiring the use of both hands. Lower score: Reveals a significant activity limitation and an increased need for assistance in personal care. |
before and immediately after intervention
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Department of PMR Sousse
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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