- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07278635
Sensory Integration Therapy and Function in Cerebral Palsy
Rewiring the Senses: The Impact of Sensory Integration Therapy on Balance and Cognition 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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Yeditepe University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
Participants in this group will receive individualized sensory integration therapy in addition to standard balance and coordination exercises. Therapy will be administered once a week for 45 minutes for a total duration of 12 weeks. Each session will include activities designed to stimulate vestibular, proprioceptive, and tactile systems to improve motor coordination, postural control, sensory processing, and cognitive function. |
To evaluate the additional effect of sensory integration therapy on motor, sensory, and cognitive outcomes.
To assess the effect of standard balance/coordination training without sensory integration.
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Active Comparator: control group
Participants in this group will receive balance and coordination exercises without sensory integration therapy. Exercises will be conducted once a week for 45 minutes over a period of 12 weeks and will include dynamic balance training, postural control activities, and coordination drills appropriate to the participant's functional level. |
To assess the effect of standard balance/coordination training without sensory integration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline (Week 0) and post-intervention (Week 12)
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Change from Baseline in Functional Independence (WeeFIM Total) at 12 Weeks
Time Frame: Baseline and Week 12
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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.
|
Baseline and Week 12
|
|
Change from Baseline in Cognitive Function (DOTCA-Ch Total) at 12 Weeks
Time Frame: Baseline and Week 12
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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.
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and Week 12
|
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Change from Baseline in Sensory Processing (Sensory Profile-Sensory Seeking Subscale) at 12 Weeks
Time Frame: Baseline and Week 12
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Parent-reported Sensory Profile subscale; scoring per instrument manual.
Directionality interpreted per manual (improvement defined a priori in analysis plan).
Endpoint is change score.
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Baseline and Week 12
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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.
|
Baseline and Week 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sensory process
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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