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NCT07895485
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Conditions: Cerebral Palsy (CP)
Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Izgi Miray Demirbag
Summary
This study will examine whether a 12-week Ayres Sensory Integration (ASI)-based physiotherapy program can improve motor skills and daily functioning in young children with cerebral palsy. Thirty children aged 3 to 6 years who meet the study criteria will be assigned to an intervention group or a control group.
Children in the intervention group will receive 36 sessions of ASI-based physiotherapy over 12 weeks. Each session will last 60 minutes and will be provided by a physiotherapist certified in ASI. Children in the control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study.
Children will be assessed before and after the 12-week study period. Assessments will include measures of motor skills, development, daily activities, sensory processing, and progress toward individual goals. The Evaluation in Ayres Sensory Integration (EASI) will be completed before the intervention only. Assessments will be carried out in a clinical setting by an assessor who is independent of the therapists providing the intervention.
Eligibility Criteria
Inclusion Criteria:
* Children aged 3 to 6 years.
* Diagnosis of cerebral palsy, classified as Level I or II according to the Gross Motor Function Classification System (GMFCS).
* Written informed consent provided by a parent or legal guardian.
* No major visual or hearing impairment that would interfere with the assessments or intervention.
Exclusion Criteria:
* GMFCS Level III, IV, or V.
* A severe orthopedic condition that could prevent participation in the intervention.
* Uncorrected visual or hearing impairment.
* Use of sedative medication that could affect the assessments or intervention.
* Epilepsy.
* Any other medical condition that could prevent safe or appropriate participation in the study.
Source: ClinicalTrials.gov (NCT07895485). StuddyBuddy aggregates publicly available trial information.