[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640478":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":33,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"University of Castilla-La Mancha","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"eTIPS Intervention","EXPERIMENTAL","Participants assigned to this arm will receive the Spanish-adapted eTIPS program, a parent-delivered, home-based early intervention for infants with perinatal stroke or risk of unilateral cerebral palsy. Families will receive training, adapted materials, and ongoing support to integrate lateralized therapeutic activities into daily routines from enrollment until corrected age 6 months.",[13],"Behavioral: eTIPS",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","Participants assigned to this arm will receive usual clinical care according to local practice, including standard neonatal, neurological, and rehabilitation follow-up. This arm serves as the comparator for feasibility, acceptability, and exploratory outcome assessment",[19],"Behavioral: Usual Clinical Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","eTIPS","Parent-delivered, home-based early therapy for infants with perinatal stroke or risk of unilateral cerebral palsy. Families receive the Spanish-adapted eTIPS materials, training, and ongoing support to integrate lateralized therapeutic activities into daily routines from enrollment until corrected age 6 months. The intervention is delivered alongside usual clinical care",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual Clinical Care","Standard neonatal, neurological, and rehabilitation follow-up according to local clinical practice. Includes routine pediatric neurology monitoring, periodic neurological evaluations to track motor development and detect early signs of unilateral cerebral palsy, and referral to pediatric rehabilitation with physiotherapy sessions (1 session\u002Fweek or biweekly, 30-45 minutes) focused on mobilizations, muscle tone control, joint range maintenance, general sensory stimulation, and basic postural guidelines.",[15],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[34,36],{"name":35,"class":6},"Newcastle University",{"name":37,"class":38},"Hemiweb","UNKNOWN","100640478","spanish-etips-for-early-therapy-in-perinatal-stroke-100640478",false,"NCT07605988","Spanish eTIPS for Early Therapy in Perinatal Stroke","Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families","eTIPS-ES","Inclusion Criteria:\n\n* Infants with confirmed unilateral perinatal stroke diagnosis by neuroimaging, identified within first 3 months of life\n* Age at recruitment ≤3 months postnatal (intervention starts when clinically stable, maximum term-equivalent age)\n* Written informed consent from parents\u002Flegal guardians\n\nExclusion Criteria:\n\n* Known progressive neurodegenerative disorder or severe medical comorbidity preventing participation (e.g., ventilation-dependent respiratory failure)\n* Extensive bilateral intracerebral lesion making lateralized intervention irrelevant\n* Concurrent participation in another clinical trial with interfering treatment","ALL","0 Months","6 Months",{"count":51,"type":52},20,"ESTIMATED","INTERVENTIONAL",[55],"NA","This study adapts and evaluates the Spanish version of eTIPS, an early home-based therapy program for infants at risk of unilateral cerebral palsy after perinatal stroke. The project has three parts: translation and cultural adaptation of the original materials, a pilot randomized feasibility study comparing eTIPS with usual care, and a qualitative study exploring family experiences, barriers, and facilitators to using the program at home.\n\nIn the first part, the study team will translate and culturally adapt the eTIPS materials for Spanish-speaking families, review them with experts, and test whether the content is clear, relevant, and usable. In the second part, families with infants diagnosed with perinatal stroke or at high risk of unilateral cerebral palsy will be assigned to either the eTIPS program or usual clinical care to assess recruitment, retention, adherence, safety, acceptability, and preliminary effects on infant motor development and family outcomes. In the third part, caregivers in the intervention group will take part in interviews to better understand how the program fits into daily life and what could improve future implementation.",[58,59,60],"Perinatal Stroke and Risk of Unilateral Cerebral Palsy","Early Parent-delivered Home-based Intervention","Spanish Cross-cultural Adaptation of eTIPS",[23,62,63,64,65],"perinatal stroke","unilateral cerebral palsy","early intervention","infant rehabilitation","NOT_YET_RECRUITING","2026-05-18",{"date":69,"type":70},"2026-05-26","ACTUAL",{"date":72,"type":52},"2026-09-01",{"date":74,"type":52},"2028-12-31",{"name":5,"class":6}]