Sensory Integration Therapy and Function in Cerebral Palsy

NCT07278635 | Completed

• 1 other identifier: sensory process
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP); Balance; Sensory Integration Disorder

Keywords

Cerebral palsy; sensory integration therapy; DOTCA-Ch; balance; functional independence level; sensory processsing

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline (Week 0) and post-intervention (Week 12)

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

  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

  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 Outcomes (3)

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

  Baseline and Week 12

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

  Baseline and Week 12

• Change from Baseline in Sensory Profile

  Baseline and Week 12

Study Arms (2)

Study group

EXPERIMENTAL

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.

Behavioral: Sensory Integration Therapy; Behavioral: Balance and Coordination Exercises

control group

ACTIVE COMPARATOR

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.

Behavioral: Balance and Coordination Exercises

Interventions

Sensory Integration Therapy BEHAVIORAL

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

Study group

Balance and Coordination Exercises BEHAVIORAL

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

Study group; control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: November 5, 2017
• Primary Completion: January 26, 2019
• Study Completion: June 26, 2019
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

TU (1)