CompletedNot Applicable

Sensory Integration Therapy and Function in Cerebral Palsy

Turkey (Türkiye)22 participantsStarted 2017-11-05

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Timeframe: Baseline and Week 12

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

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT07278635

SponsorYeditepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-26

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials

Plain-language summary

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

Timeframe: Baseline and Week 12

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

Timeframe: Baseline and Week 12