[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04886895":3,"trial-entities:NCT04886895":105,"trial-summary:NCT04886895":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":73,"locations":75,"central_contacts":95,"overall_officials":100,"references":103,"see_also_links":104},"NCT04886895","2021-0305","Motor Training for Infants With Cerebral Palsy","Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability","RECRUITING","2028-01-01","2025-09","2025-09-25","2022-01-07","Children's Hospital Medical Center, Cincinnati","OTHER",false,"The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.","The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called \"Let's Move\" delivered using a combined clinic and home (video telehealth) therapy model.",[19],"Cerebral Palsy",[21,22,23],"motor skills","occupational therapy","physical therapy","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},35,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Let's Move Motor Intervention","Let's Move intervention will be administered and videotaped with infant\u002Fcaregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions",[36,37],"Control group","Intervention group: Let's Move",[39],{"measure":40,"description":41,"timeFrame":42},"Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up","Motor test","Baseline,16 weeks, 28 weeks",[44,47,50,53],{"measure":45,"description":46,"timeFrame":42},"Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up","Parent reported test for functional performance",{"measure":48,"description":49,"timeFrame":42},"Change on Canadian Occupational Performance Measure before and after intervention and follow-up","Caregivers perception of child's performance on functional goals",{"measure":51,"description":52,"timeFrame":42},"Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up","Neurological exam",{"measure":54,"description":55,"timeFrame":56},"Preverbal visual assessment (PreViAs","Screening tool for the development of visual maturation","Enrollment, 4 months later, 8 months later","ALL","3 Months","8 Months",{"inclusion":61,"exclusion":68,"raw_text":72},[62,63,64,65,66,67],"Age at enrollment: between 3-8 months corrected age","Caregivers fluent in English","Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR","High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia\u002Fthalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and\u002For severe intraventricular\u002Fperiventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:","\"Absent\" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR","A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)",[69,70,71],"Medical conditions that restrict active participation such as oxygen dependence","Infants with significant visual deficits defined by the inability to track an object horizontally","Living in a remote location prohibiting drives to the hospital every other week.","Inclusion Criteria:\n\n* Age at enrollment: between 3-8 months corrected age\n* Caregivers fluent in English\n* Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR\n* High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia\u002Fthalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and\u002For severe intraventricular\u002Fperiventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:\n\n  * \"Absent\" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR\n  * A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)\n\nExclusion Criteria:\n\n* Medical conditions that restrict active participation such as oxygen dependence\n* Infants with significant visual deficits defined by the inability to track an object horizontally\n* Living in a remote location prohibiting drives to the hospital every other week.",[74],"CHILD",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":92},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229","United States",[83,88],{"name":84,"role":85,"phone":86,"email":87},"Karen L Harpster, PhD, OTR\u002FL","CONTACT","513-803-3604","karen.harpster@cchmc.org",{"name":89,"role":85,"phone":90,"email":91},"Nehal A Parikh, DO, MS","513 517-1044","nehal.parikh@cchmc.org",{"lat":93,"lon":94},39.12711,-84.51439,[96,98],{"name":97,"role":85,"phone":86,"email":87},"Karen Harpster, PhD, OTR\u002FL",{"name":89,"role":85,"phone":99,"email":91},"513-517-1044",[101],{"name":97,"affiliation":13,"role":102},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":107},[19],[],{"nct_id":4,"found":109,"summary":110,"prompt_version":119},true,{"design":111,"status":112,"heading":6,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 35 participants.","completed","This study is testing a new motor intervention called \"Let's Move\" for infants who are at risk for cerebral palsy. The researchers want to see if this intervention is practical and well-received by families, and if it shows early signs of helping infants' motor development. You might be able to join if your infant is between 3 and 8 months old (corrected age) and has certain risk factors for cerebral palsy, such as specific findings on an MRI or ultrasound. Caregivers must also be fluent in English. The main goal is to measure changes in your infant's motor skills using a test called the Peabody Developmental Scales - Second Edition, both before and after the intervention, and again later. The current status of this study is unclear, and it plans to enroll 35 participants.","Your infant's motor skills will be assessed at baseline, after 16 weeks of intervention, and again at 28 weeks.",134,"Participants will receive the Let's Move intervention weekly for 16 weeks, with sessions lasting 30-60 minutes. These sessions will alternate between clinic visits and home-based video telehealth appointments.","Not stated in the trial record.",[],"v2"]