[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605535":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":62,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HEP Intervention","EXPERIMENTAL","Participants will receive 12 sessions of HEP therapy, once per week, 45 minutes each.",[13],"Behavioral: HEP Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Therapy","ACTIVE_COMPARATOR","Participants will receive 12 sessions of traditional therapy, once per week, 45 minutes each.",[19],"Behavioral: Traditional Therapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","This intervention is administered to the HEP Intervention arm.\n\nThe HEP approach, which includes intervention, is a child-centered, family-based early intervention approach based on the principles of enriched environment and plasticity, emphasizing the importance of homeostasis. It is based on theories that argue that development occurs as a result of the dynamic interaction between the environment, time, task, and individual (Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model). Hypotheses for intervention are generated based on a comprehensive assessment of these four fundamental factors (environment, time, task, and individual), and 10 core principles derived from environmental enrichment studies are applied with the guidance of ecological models.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants in this arm will receive conventional pediatric therapy, consisting of 12 weekly sessions of 45 minutes each. Sessions will focus on standard motor and sensory development exercises, delivered by a physical therapist experienced in pediatric rehabilitation.",[15],[30],{"name":31,"affiliation":25,"role":32},"Aymen Balıkcı, Dr. Physiotherapist","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"İzgi Miray Demirbağ, Physiotherapist","CONTACT","+905516626550","izgimiray@hotmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Gamze Cagla Sırma, Physiotherapist","+905454470067","cagladirgen@hotmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":25,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Sense On","RECRUITING","Istanbul","Beykoz","34810","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],28.94966,41.01384,{"lat":55,"lon":54},[58,60],{"name":31,"role":36,"phone":59,"phoneExt":25,"email":38},"05069328294",{"name":61,"role":36,"phone":41,"phoneExt":25,"email":38},"Aymen Cagla Sırma, Dr. Physiotherapist",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Izgi Miray Demirbag","Physiotherapist","100605535","the-effect-of-the-hep-approach-in-infants-with-down-syndrome-100605535",false,"NCT07163780","The Effect of the HEP Approach in Infants With Down Syndrome","The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome","HEP-DS","Inclusion Criteria:\n\n* Must be between 4 and 12 months old\n* Must have been diagnosed with Down Syndrome\n* Must not be at any neurological risk\n* Parent must agree to participate regularly in the study process\n\nExclusion Criteria:\n\n* History of intraventricular hemorrhage (Grade III or IV)\n* Major vision or hearing impairment\n* History of febrile convulsion\n* Medical conditions (e.g., oxygen dependence) that prevent active participation in the study\n* Participation in other experimental rehabilitation studies","ALL","4 Months","12 Months",{"count":78,"type":79},26,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.",[85],"Down Syndrome (DS)",[87,88,89,90,91],"Down Syndrome","Infants","Early Intervention","Neuroplasticity","Environmental Enrichment","2025-11-13",{"date":94,"type":95},"2025-11-14","ACTUAL",{"date":97,"type":95},"2025-09-03",{"date":99,"type":79},"2025-12-03",{"name":64,"class":6},1]