Cerebral Palsy (CP)NCT07278635
Sensory Integration Therapy and Function in Cerebral Palsy
A study testing Sensory Integration Therapy and Balance and Coordination Exercises in people with Cerebral Palsy (CP) and Balance, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP), Balance, Sensory Integration Disorder
- What is being tested?
- Sensory Integration Therapy and Balance and Coordination Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2017to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy (CP), Balance, Sensory Integration Disorder
- Being tested
- Sensory Integration Therapy, Balance and Coordination Exercises
- Keywords
- Cerebral palsy, sensory integration therapy, DOTCA-Ch, balance, functional independence level, sensory processsing
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration TherapyBehavioural
To evaluate the additional effect of sensory integration therapy on motor, sensory, and cognitive outcomes.
Balance and Coordination ExercisesBehavioural
To assess the effect of standard balance/coordination training without sensory integration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Balance and Coordination Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (3)
Change from Baseline in Timed Up and Go (TUG) at 12 Weeks
TUG measured in seconds; lower times indicate better functional mobility/agility. Endpoint is change score.
Measured: Baseline and Week 12
Change from Baseline in Sensory Processing (Sensory Profile-Sensory Seeking Subscale) at 12 Weeks
Parent-reported Sensory Profile subscale; scoring per instrument manual. Directionality interpreted per manual (improvement defined a priori in analysis plan). Endpoint is change score.
Measured: Baseline and Week 12
Change from Baseline in Sensory Profile
Parent-reported Sensory Profile subscale; scoring per instrument manual. Directionality interpreted per manual (improvement defined a priori in analysis plan). Endpoint is change score.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start5 Nov 2017
- Primary completion26 Jan 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278635
- Sponsor's protocol ID
- sensory process
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rewiring the Senses: The Impact of Sensory Integration Therapy on Balance and Cognition in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07278635
- Acronym / sponsor ID
- sensory process
- Conditions
- Cerebral Palsy (CP), Balance, Sensory Integration Disorder
- Keywords
- Cerebral palsy, sensory integration therapy, DOTCA-Ch, balance, functional independence level, sensory processsing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 26 Jan 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Sensory Integration Therapy, Behavioral: Balance and Coordination ExercisesParticipants 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. |
| control group | Active comparator | Behavioral: Balance and Coordination ExercisesParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- • Receipt of Botulinum toxin-A (BTX-A) treatment within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Integration TherapyTo evaluate the additional effect of sensory integration therapy on motor, sensory, and cognitive outcomes. | Behavioural | Study group |
| Balance and Coordination ExercisesTo assess the effect of standard balance/coordination training without sensory integration. | Behavioural | Study group, control group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change from Baseline in Timed Up and Go (TUG) at 12 Weeks
Time frame: Baseline and Week 12
Change from Baseline in Sensory Processing (Sensory Profile-Sensory Seeking Subscale) at 12 Weeks
Time frame: Baseline and Week 12
Change from Baseline in Sensory Profile
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Therapy and Balance and Coordination Exercises in people with Cerebral Palsy (CP) and Balance, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pediatric Berg Balance Scale (PBBS) at 12 Weeks (time frame: Baseline (Week 0) and post-intervention (Week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.