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Completed

NCT Number: NCT07278635

Sensory Integration Therapy and Function in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy (CP) Balance Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Sensory Integration Disorder

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of cerebral palsy

Age between 6 and 10 years

Gross Motor Function Classification System (GMFCS) Level I or II Ability to understand and follow verbal instructions No severe visual or hearing impairment that interferes with communication Ability to attend and complete the treatment program within the specified duration Enrollment in a special education and rehabilitation center Parental consent obtained for participation in the study

Exclusion criteria

  • • Receipt of Botulinum toxin-A (BTX-A) treatment within the past 6 months
  • History of hip, knee, or ankle surgery within the past 12 months
  • Presence of severe intellectual disability that prevents active participation
  • Refusal to participate in the study by the child or parent

Treatment and study plan

Sensory Integration Therapy

Behavioral

To evaluate the additional effect of sensory integration therapy on motor, sensory, and cognitive outcomes.

Balance and Coordination Exercises

Behavioral

To assess the effect of standard balance/coordination training without sensory integration.

Primary outcomes

  1. Change from Baseline in Pediatric Berg Balance Scale (PBBS) at 12 Weeks

    Time frame: Baseline (Week 0) and post-intervention (Week 12)

    PBBS (14 items; total 0-56). Higher scores indicate better balance. Primary endpoint is the change score (Week 12 minus Baseline). Assessed by a blinded outcomes assessor.

  2. Change from Baseline in Functional Independence (WeeFIM Total) at 12 Weeks

    Time frame: Baseline and Week 12

    WeeFIM total score (self-care, mobility, cognition domains; standard scoring). Higher scores indicate greater independence. Primary endpoint is the change score. Assessed by a blinded outcomes assessor.

  3. Change from Baseline in Cognitive Function (DOTCA-Ch Total) at 12 Weeks

    Time frame: Baseline and Week 12

    Dynamic Occupational Therapy Cognitive Assessment for Children (DOTCA-Ch) total score; higher scores reflect better cognitive performance. Primary endpoint is the change score. Assessed by a blinded outcomes assessor.

Secondary outcomes

  1. Change from Baseline in Timed Up and Go (TUG) at 12 Weeks

    Time frame: Baseline and Week 12

    TUG measured in seconds; lower times indicate better functional mobility/agility. Endpoint is change score.

  2. Change from Baseline in Sensory Processing (Sensory Profile-Sensory Seeking Subscale) at 12 Weeks

    Time frame: Baseline and Week 12

    Parent-reported Sensory Profile subscale; scoring per instrument manual. Directionality interpreted per manual (improvement defined a priori in analysis plan). Endpoint is change score.

  3. Change from Baseline in Sensory Profile

    Time frame: Baseline and Week 12

    Parent-reported Sensory Profile subscale; scoring per instrument manual. Directionality interpreted per manual (improvement defined a priori in analysis plan). Endpoint is change score.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

Rewiring the Senses: The Impact of Sensory Integration Therapy on Balance and Cognition in Cerebral Palsy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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