Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT07278635
Brief Summary:
Cerebral palsy (CP) is a non-progressive neurological disorder that affects movement, posture, and functional abilities. Children with CP frequently experience impairments in motor control, sensory processing, balance, postural stability, and cognitive functioning. Sensory integration therapy (SIT) is a therapeutic approach designed to improve the processing and organization of sensory information and may support motor planning and functional performance.
This randomized controlled study aims to examine the effects of sensory integration therapy combined with balance and coordination exercises in children with spastic-type cerebral palsy. Participants will be randomly assigned to receive either balance and coordination training alone or in combination with sensory integration therapy for a 12-week period.
Primary outcomes include balance, functional mobility, and functional independence. Secondary outcomes include sensory processing patterns and cognitive performance. All assessments will be conducted at baseline and following the intervention period by blinded evaluators. The study seeks to provide additional evidence regarding the potential benefits of sensory-based therapeutic approaches within pediatric rehabilitation for children with cerebral palsy.
Detailed Description:
Cerebral palsy (CP) is characterized by permanent disorders of movement and posture resulting from non-progressive disturbances in the developing fetal or infant brain. Children with CP frequently exhibit motor impairments, sensory processing difficulties, deficits in postural control, and limitations in functional activities. Sensory integration therapy (SIT) is a neurodevelopmental intervention designed to improve the brain's ability to process and organize sensory information, particularly vestibular, proprioceptive, tactile, and visual inputs. Although SIT is commonly used in pediatric rehabilitation, evidence regarding its effects on balance, sensory processing, functional independence, and cognitive skills in children with CP remains limited.
This randomized controlled study aims to evaluate the effects of sensory integration therapy combined with a structured balance and coordination exercise program in children with spastic-type cerebral palsy. Participants will be assigned to either a study group receiving both sensory integration therapy and balance/coordination exercises or a control group receiving only balance/coordination exercises. The intervention will last 12 weeks, with one 45-minute session per week for each component of the program.
Primary outcomes include balance, functional mobility, and functional independence, assessed using the Pediatric Berg Balance Scale (PBBS), the Timed Up and Go Test (TUG), and the Functional Independence Measure for Children (WeeFIM), respectively. Secondary outcomes include sensory processing, evaluated with the Sensory Profile, and cognitive abilities, assessed with the Dynamic Occupational Therapy Cognitive Assessment for Children (DOTCA-Ch). All assessments will be conducted before and after the 12-week intervention period by evaluators blinded to group allocation.
The study is designed to contribute to expanding knowledge on sensory-based rehabilitation strategies and to clarify the potential added value of sensory integration therapy within multidisciplinary treatment approaches for children with cerebral palsy.
Study:
NCT07278635
Study Brief:
Protocol Section:
NCT07278635