[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653672":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":36,"studyPopulation":26,"armGroups":37,"interventions":50,"overallOfficials":60,"centralContacts":64,"locations":72,"responsibleParty":88,"collaborators":26,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":26,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":26,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Medipol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Occupational Performance","Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure. Higher scores will indicate better perceived occupational performance.","Baseline and Week 12",{"measure":14,"description":15,"timeFrame":12},"Change in Satisfaction with Occupational Performance","Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure. Higher scores will indicate greater satisfaction.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"Change in Sensory Processing","Sensory processing will be assessed using the Dunn Sensory Profile. Scale scores will be interpreted according to the instrument's standardized scoring system.",{"measure":21,"description":22,"timeFrame":12},"Change in Gross Motor Development","Gross motor development will be assessed using the Test of Gross Motor Development Third Edition, including locomotor and ball skills subscales. Higher scores will indicate better gross motor performance.",{"measure":24,"description":25,"timeFrame":12},"Change in Eating Behaviors","Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"SINGLE","Because of the nature of the interventions, participants and treating physiotherapists will be aware of the allocated intervention. Outcome assessments will be conducted by an independent physiotherapist who will be blinded to group allocation. Statistical analyses will be performed by a biostatistician who will be blinded to the coded group assignments.",[35],"OUTCOMES_ASSESSOR","This controlled clinical study will evaluate the effects of a structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder.\n\nA total of 40 children aged 3-9 years with Level 2 autism spectrum disorder will be assigned to a structured sensory-based occupational therapy group (n=20) or a control group (n=20). The intervention group will receive 40-minute, face-to-face occupational therapy sessions twice weekly for 12 weeks. The sessions will be structured according to each child's sensory and functional needs and will be progressively adapted based on the child's clinical development. The control group will receive individualized home recommendations, which will be monitored weekly using information and visual records provided by caregivers.\n\nAssessments will be performed at baseline and after 12 weeks. Occupational performance and satisfaction will be evaluated using the Canadian Occupational Performance Measure, sensory processing using the Dunn Sensory Profile, gross motor development using the Test of Gross Motor Development-Third Edition, and eating behaviors using the Children's Eating Behaviour Questionnaire.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Structured Sensory-Based Occupational Therapy Group","EXPERIMENTAL","Participants in this group will receive 40-minute, face-to-face structured sensory-based occupational therapy sessions twice weekly for 12 weeks. The intervention will be individualized according to each child's sensory and functional needs and will include tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance activities. Session content will be progressively adapted according to the child's development. Caregivers will also receive brief recommendations for home practice.",[43],"Behavioral: Structured Sensory-Based Occupational Therapy",{"label":45,"type":46,"description":47,"interventionNames":48},"Home Program Control Group","ACTIVE_COMPARATOR","Participants in this group will receive individualized home-based activity recommendations using materials available in the home environment. The home program will be implemented for 12 weeks and will be monitored weekly for approximately 10 minutes using verbal information and visual records provided by caregivers. Participants will not receive face-to-face structured sensory-based occupational therapy during the study period.",[49],"Behavioral: Individualized Home Activity Program",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":26},"BEHAVIORAL","Structured Sensory-Based Occupational Therapy","The intervention will consist of individualized sensory-based occupational therapy activities addressing tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance needs. It will be delivered face-to-face for 40 minutes, twice weekly, over 12 weeks, and will be progressively adapted according to each child's clinical needs and development.",[39],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":26},"Individualized Home Activity Program","Caregivers will implement individualized home-based sensory and functional activity recommendations using materials available in the home environment. The program will continue for 12 weeks and adherence will be monitored weekly through caregiver reports and visual records.",[45],[61],{"name":62,"affiliation":5,"role":63},"Emre DANSUK, PhD","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},"Emre Dansuk, PhD","CONTACT","05377790434","edansuk@medipol.edu.tr",{"name":71,"role":67,"phone":26,"phoneExt":26,"email":26},"Burak Menek, PhD",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":26,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Emre Dansuk","RECRUITING","Istanbul","Beykoz","34815","Turkey (Türkiye)",{"type":81,"coordinates":82},"Point",[83,84],28.94966,41.01384,{"lat":84,"lon":83},[87],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Emre DANSUK","Principal Investigator","100653672","structured-sensory-based-occupational-therapy-in-children-with-autism-100653672",false,"NCT07789704","Structured Sensory-Based Occupational Therapy in Children With Autism","Effects of Structured Sensory-Based Occupational Therapy on Occupational Performance and Sensory-Motor Outcomes in Children With Autism Spectrum Disorder: A Controlled Clinical Study","Inclusion Criteria:\n\n* Children aged 3-9 years\n* Diagnosis of autism spectrum disorder according to DSM-5 criteria\n* Level 2 autism spectrum disorder\n* Residence in Istanbul\n* Written informed consent provided by a parent or legal guardian\n\nExclusion Criteria:\n\n* Presence of an additional neurological, psychiatric, genetic, or developmental diagnosis\n* Regular medication use that may affect study outcomes\n* History of epilepsy or seizures\n* Inability to participate in the assessment or intervention procedures\n* Participation in another structured sensory-based occupational therapy program during the study period",true,"ALL","3 Years","9 Years",{"count":104,"type":105},40,"ESTIMATED","INTERVENTIONAL",[108],"NA","This controlled clinical study will investigate the effects of a 12-week structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder. Forty children aged 3-9 years will be assigned to either an intervention group receiving face-to-face occupational therapy twice weekly or a control group receiving an individualized home program.",[111],"Autism Spectrum Disorder",[111,113,114,115],"Occupational Therapy","Sensory-Based Intervention","Children","2026-09-07",{"date":118,"type":119},"2026-09-10","ACTUAL",{"date":121,"type":119},"2026-08-28",{"date":123,"type":105},"2026-11-01",{"name":90,"class":6},1]