- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shaymaa Rushdy Mahmoud, lecturer
- Número de teléfono: 0201145050053
- Correo electrónico: shaymaa.rushdy@pt.cu.edu.eg
Ubicaciones de estudio
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Giza Governorate
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Dokki, Giza Governorate, Egipto
- Reclutamiento
- outpatient clinic, faculty of physical therapy, Cairo university
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Contacto:
- Shaymaa Rushdy Mahmoud, lecturer
- Número de teléfono: 0201145050053
- Correo electrónico: shaymaa.rushdy@pt.cu.edu.eg
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Sub-Investigador:
- Shaymaa Rushdy Mahmoud, Lecturer of Physical Therapy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gait Speed
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Step Width
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- No:P.T.REC/012/006158
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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