Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-02 @ 7:48 AM
Study NCT ID:
NCT04886895
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2021-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Training for Infants With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single cohort'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up', 'timeFrame': 'Baseline,16 weeks, 28 weeks', 'description': 'Motor test'}], 'secondaryOutcomes': [{'measure': 'Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up', 'timeFrame': 'Baseline,16 weeks, 28 weeks', 'description': 'Parent reported test for functional performance'}, {'measure': 'Change on Canadian Occupational Performance Measure before and after intervention and follow-up', 'timeFrame': 'Baseline,16 weeks, 28 weeks', 'description': "Caregivers perception of child's performance on functional goals"}, {'measure': 'Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up', 'timeFrame': 'Baseline,16 weeks, 28 weeks', 'description': 'Neurological exam'}, {'measure': 'Preverbal visual assessment (PreViAs', 'timeFrame': 'Enrollment, 4 months later, 8 months later', 'description': 'Screening tool for the development of visual maturation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor skills', 'occupational therapy', 'physical therapy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': '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/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular 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.'}, 'identificationModule': {'nctId': 'NCT04886895', 'briefTitle': 'Motor Training for Infants With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability', 'orgStudyIdInfo': {'id': '2021-0305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': "Infants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group.", 'interventionNames': ["Other: Let's Move Motor Intervention"]}, {'type': 'EXPERIMENTAL', 'label': "Intervention group: Let's Move", 'description': "Infants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity.", 'interventionNames': ["Other: Let's Move Motor Intervention"]}], 'interventions': [{'name': "Let's Move Motor Intervention", 'type': 'OTHER', 'description': "Let's Move intervention will be administered and videotaped with infant/caregiver 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", 'armGroupLabels': ['Control group', "Intervention group: Let's Move"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen L Harpster, PhD, OTR/L', 'role': 'CONTACT', 'email': 'karen.harpster@cchmc.org', 'phone': '513-803-3604'}, {'name': 'Nehal A Parikh, DO, MS', 'role': 'CONTACT', 'email': 'nehal.parikh@cchmc.org', 'phone': '513 517-1044'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Karen Harpster, PhD, OTR/L', 'role': 'CONTACT', 'email': 'karen.harpster@cchmc.org', 'phone': '513-803-3604'}, {'name': 'Nehal A Parikh, DO, MS', 'role': 'CONTACT', 'email': 'nehal.parikh@cchmc.org', 'phone': '513-517-1044'}], 'overallOfficials': [{'name': 'Karen Harpster, PhD, OTR/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karen Harpster', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}