- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07654595
Digital Mirror Versus Action Observation Therapy on Upper Limb Function and Grip Strength in Children With Hemiplegia
Statement of problem:
- Does the digital mirror therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does the action observation therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does there is a difference between effect of digital mirror therapy and action observation therapy on upper limb function and grip strength in children with hemiplegia?
Null hypothesis:
there is no effect of digital mirror therapy on upper limb function and grip strength in children with hemiplegia. There is no effect of action observation therapy on upper limb function and grip strength in children with hemiplegia. There is no difference between effect of digital mirror therapy and Action observation therapy on upper limb function and grip strength in children with hemiplegia.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Subjects:
The study targets the children from both sexes,diagnosed with hemiplegia,Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,
Study design:
Randomized controlled clinical trial, Children will receive intervention type randomly(3 groups), 15 children will receive digital mirror therapy,15 children will receive action observation therapy, 15 children will receive designed occupational therapy program.
Children will be assessed by Gross Motor Function Classification System (GMFCS) and Manual ability classification system (MACS) for inclusion and Quality of upper extremity skill test, Box and Block Test (BBT) and Hand held dynanmometer which reflect clinical improvement in upper limb function and grip strength before and after 3 months of receiving intervention
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte
- Cairo University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- 1 Diagnosed with unilateral cerebral palsy (hemiplegia). 2- Age range from 6 to 8 years. 3- Can understand verbal commands. 4- Their gross motor classification system (GMFCS) at level II or III. 5- Their manual ability classification system(MACS) at level II or III.
Exclusion Criteria:
1- Any visual problem. 2- Upper limb contracture or fixed deformity. 3- Uncontrolled convulsion. 4- Surgical procedures in upper limbs. 5- Botox injection in the past 6 months.
Plan d'étude
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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Expérimental: digital mirror therapy
Children are asked to perform movements of the less affected upper limb, in which those movements are captured by a webcam and then instantly transformed into mirror images of the movements presented on the screen over the paralyzed upper limb, and children can simultaneously observe the mirror images of the movements from the front and simultaneously moved the more affected arm/hand as much as possible, imagining the movements on the screen were performed by their more affected limb, same exercises as designed occupational therapy program, for 1 hour, one session per day , 3 days per week for 12weeks.
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Child will be asked to do the same exercises mentioned in the designed occupational therapy program with the less affected upper limb and the web cam camera will record the movement, instantly transformed into mirror images of the more affected upper limb's movements presented on the screen in front of child.
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Expérimental: action observation therapy
children observed one video clip of a movement or task for 2 min and then practiced executing the same action for 3 min, which the two phases will be applied one time for each exercises, same exercises as designed occupational therapy program
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the child will be offered to tablet screen put in front of him 50 centimeters away, time for each video will last for 2 min.
Then, the child will be asked to repeat the observed action in the best possible way.
All the activities included in the designed occupational therapy program will be observed and imitated.
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Comparateur actif: designed occupational therapy program
Active occupational therapy exercises for upper limb training.
The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball .
(b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm, thumb to fingers opposition and drawing using tripod grasp for 1 hour, one session per day , 3 days per week for 12weeks.
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Active occupational therapy exercises for upper limb training. The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball ,(b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm. thumb to fingers opposition and drawing using tripod grasp. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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assessment of upper limb function
Délai: 3 months
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The Quality of Upper Extremity Skills Test (QUEST) is one of the most recommended assessment tools.
It aims to evaluate upper limb movement quality and capacity in children with CP, it has four domains dissociated movement, grasp, protective extension and weight bearing.
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3 months
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assessment of manual dextriry
Délai: 3 months
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Box and block test (BBT) examines essential components of manual dexterity for developing children, such as grasping, holding, transferring, and releasing
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3 months
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assessment of grip strength
Délai: 3 months
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Hydraulic Handheld Dynamometer will be used to assess the maximum isometric strength of the hand muscles, Grip strength is a key predictor of functional ability.
Neuralplasticity, sensorimotor integration, and musculoskeletal function.
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3 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P.T.REC/012/006461
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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