- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07595744
Sensory Walkway and Gait in Children With Diplegic Cerebral Palsy (SWGCP)
Effect of Sensory Walkway on Gait Parameters in Children With Diplegic Cerebral Palsy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study will be conducted after approval from the Ethical Committee of the Faculty of Physical Therapy, Cairo University, and will follow the ethical principles of the Declaration of Helsinki. Written informed consent will be obtained from the parents of all participating children.
The intervention involves the use of a structured sensory walkway composed of eight wooden foot boxes filled with different textured materials, including polyester fiberfill, cut plastic straws, foam beads, and kinetic sand. This setup is designed to provide continuous multimodal tactile stimulation during gait training to enhance sensory-motor integration, postural control, and gait performance. Children in the intervention group will perform reciprocal gait training while interacting with the sensory surfaces, accompanied by verbal feedback to facilitate sensory awareness and motor engagement.
Both groups will receive a traditional physical therapy program including stretching exercises, quadruped and kneeling activities, balance training, stepper exercises, and gait training on various surfaces and equipment.
Data will be analyzed using descriptive statistics (mean and standard deviation), and statistical analysis will be performed using IBM SPSS software.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Shaymaa Rushdy Mahmoud, lecturer
- Numéro de téléphone: 0201145050053
- E-mail: shaymaa.rushdy@pt.cu.edu.eg
Lieux d'étude
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Giza Governorate
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Dokki, Giza Governorate, Egypte
- Recrutement
- outpatient clinic, faculty of physical therapy, Cairo university
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Contact:
- Shaymaa Rushdy Mahmoud, lecturer
- Numéro de téléphone: 0201145050053
- E-mail: shaymaa.rushdy@pt.cu.edu.eg
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Sous-enquêteur:
- Shaymaa Rushdy Mahmoud, Lecturer of Physical Therapy
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Clinical diagnosis of spastic diplegic cerebral palsy
- Aged between 5 and 7 years
- Classified at level II on the Gross Motor Function Classification System
- Spasticity grade 1 or 1+ according to the Modified Ashworth Scale
- Able to walk independently or with an assistive device without physical assistance
- Able to follow verbal commands
- Abnormal gait pattern
Exclusion Criteria:
- Visual or auditory impairment
- History of lower limb surgery within the past 2 years
- Use of medications affecting muscle tone and/or cognitive function
- Contractures or fixed deformities in upper or lower limbs
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Control Group - Conventional Physical Therapy
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
|
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
|
|
Expérimental: Study Group - Conventional Physical Therapy plus Sensory Walkway Training
Participants in the study group will receive conventional physical therapy including stretching, strengthening, balance exercises, and gait training.
In addition, they will undergo gait training on a sensory walkway consisting of wooden foot boxes filled with different textured materials to provide tactile stimulation.
Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input.
Children will walk through the walkway while immersing their feet and hands in the textured materials and are encouraged to identify and describe textures to enhance sensory awareness.
The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy.
Each session lasts 60 minutes and is performed three times per week for three months.
|
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
Participants in the study group will receive conventional physical therapy in addition to gait training on a sensory walkway.
The sensory walkway consists of a sequence of wooden foot boxes filled with different textured materials to provide tactile stimulation of the feet during walking.
Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input.
This setup enables reciprocal sensory stimulation of upper and lower limbs during gait training.
Children will walk through the walkway in a controlled manner while immersing their feet and hands in the textured materials and are encouraged to identify and describe the textures to enhance sensory awareness.
The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy.
Each session lasts 60 minutes and is performed three times per week for three months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Gait Speed
Délai: 3 months
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Gait speed (m/s) will be assessed using the 10-Meter Walk Test (10MWT).
Participants will walk a 10-meter distance at a self-selected comfortable walking speed.
Time recorded during the test will be used only to calculate gait speed.
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3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Step Width
Délai: 3 months
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Step width (cm) will be assessed using Kinovea software based on video recordings.
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3 months
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Cadence
Délai: 3 months
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Cadence (steps/min) will be calculated using gait cycle analysis from Kinovea software
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3 months
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Step Time
Délai: 3 months
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Step time (seconds) will be analyzed using Kinovea software based on video-based gait cycle timing.
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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
- No:P.T.REC/012/006158
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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