Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-05 @ 6:01 PM
Study NCT ID:
NCT03534466
Status:
TERMINATED
Last Update Posted:
2023-12-29
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}, {'id': 'D007969', 'term': 'Leukomalacia, Periventricular'}, {'id': 'D007647', 'term': 'Kernicterus'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004678', 'term': 'Encephalomalacia'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D004899', 'term': 'Erythroblastosis, Fetal'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment All subjects were divided into two groups: intervention group A (treadmill intervention + routine physical rehabilitation therapy) and positive control group (receiving routine physical rehabilitation therapy only).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-27', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'step frequency', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': "This variable is a number that records the infants' number of coordinated gaits in all gait training processes."}, {'measure': 'age of onset of independent walking', 'timeFrame': 'The length of time from birth to the corrected age of 2 years', 'description': 'This variable is a gait parameter, recording a point in time the baby will start walking independently.'}], 'secondaryOutcomes': [{'measure': 'age of onset of walking with assistance', 'timeFrame': 'The length of time from birth to the corrected age of 2 years', 'description': 'This variable is a gait parameter, recording a point in time the baby will start walking with assistance.'}, {'measure': 'step length', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': 'The length of displacement formed by the same foot after completing a gait.'}, {'measure': 'step width', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': 'The vertical distance between the parallel lines of two medial plantar edges'}, {'measure': 'gait double-limb support', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': 'The percentage of two-limb support gait in the whole training process.'}, {'measure': 'gait ankle plantar flexion', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': 'The percentage of gait ankle plantar flexion in the whole training process.'}, {'measure': 'toe-off', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': 'The percentage of toe-off gait in the whole training process.'}, {'measure': 'gait ankle dorsiflexion', 'timeFrame': 'The length of time from birth to the corrected age of 18 months', 'description': 'The percentage of ankle dorsiflexion gait in the whole training process.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treadmill', 'infants', 'neonatal encephalopathy', 'neonatal brain injury'], 'conditions': ['Hypoxic-Ischemic Encephalopathy', 'Periventricular Leukomalacia', 'Intraventricular Hemorrhage Neonatal', 'Bilirubin Encephalopathy', 'Kernicterus', 'Hypoglycemia, Neonatal', 'Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '26828941', 'type': 'RESULT', 'citation': 'Vasudevan EV, Patrick SK, Yang JF. Gait Transitions in Human Infants: Coping with Extremes of Treadmill Speed. PLoS One. 2016 Feb 1;11(2):e0148124. doi: 10.1371/journal.pone.0148124. eCollection 2016.'}, {'pmid': '25782975', 'type': 'RESULT', 'citation': 'Teulier C, Lee DK, Ulrich BD. Early gait development in human infants: Plasticity and clinical applications. Dev Psychobiol. 2015 May;57(4):447-58. doi: 10.1002/dev.21291. Epub 2015 Mar 18.'}, {'pmid': '25644966', 'type': 'RESULT', 'citation': 'Siekerman K, Barbu-Roth M, Anderson DI, Donnelly A, Goffinet F, Teulier C. Treadmill stimulation improves newborn stepping. Dev Psychobiol. 2015 Mar;57(2):247-54. doi: 10.1002/dev.21270. Epub 2015 Feb 2.'}, {'pmid': '25123212', 'type': 'RESULT', 'citation': 'de Klerk CC, Johnson MH, Heyes CM, Southgate V. Baby steps: investigating the development of perceptual-motor couplings in infancy. Dev Sci. 2015 Mar;18(2):270-80. doi: 10.1111/desc.12226. Epub 2014 Aug 13.'}, {'pmid': '24136687', 'type': 'RESULT', 'citation': 'Madhavan S, Campbell SK, Campise-Luther R, Gaebler-Spira D, Zawacki L, Clark A, Boynewicz K, Kale D, Bulanda M, Yu J, Sui Y, Zhou XJ. Correlation between fractional anisotropy and motor outcomes in one-year-old infants with periventricular brain injury. J Magn Reson Imaging. 2014 Apr;39(4):949-57. doi: 10.1002/jmri.24256. Epub 2013 Oct 17.'}, {'pmid': '24012586', 'type': 'RESULT', 'citation': 'Angulo-Barroso RM, Tiernan C, Chen LC, Valentin-Gudiol M, Ulrich D. Treadmill training in moderate risk preterm infants promotes stepping quality--results of a small randomised controlled trial. Res Dev Disabil. 2013 Nov;34(11):3629-38. doi: 10.1016/j.ridd.2013.07.037. Epub 2013 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy. The aim of our study was to conduct early treadmill training in infants who were highly suspected of cerebral palsy and to follow up on their long-term gait development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gestational age \\< 33W;\n2. Correction of gestational age \\< 3 months;\n3. It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.\n4. There was no other therapeutic intervention before entering the study;\n5. Informed consent is signed by the family.\n\nExclusion Criteria:\n\n1. Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);\n2. Brain damage caused by convulsion;\n3. Metabolic brain damage caused by genetic defects;\n4. Suffering from known severe congenital malformations;\n5. Definite head trauma during labor or postpartum;\n6. Peripheral neuromuscular disease or abnormal skeletal system.'}, 'identificationModule': {'nctId': 'NCT03534466', 'briefTitle': 'Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill', 'orgStudyIdInfo': {'id': 'CHFudanU_NNICU9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Baby treadmill + conventional physical rehabilitation training', 'interventionNames': ['Device: Baby treadmill', 'Behavioral: Conventional physical rehabilitation training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'positive control group', 'description': 'Conventional physical rehabilitation training only', 'interventionNames': ['Behavioral: Conventional physical rehabilitation training']}], 'interventions': [{'name': 'Baby treadmill', 'type': 'DEVICE', 'description': 'The newborns who received treadmill intervention were stimulated by running 3 times a week for a total of 10 minutes each time (complete in 5 cycles, 2 minutes per cycle, 2 minutes after the completion of one cycle and rest for 2 minutes to start the next cycle). Until the completion and completion of the five cycles). During the remaining four days of each week, other physical rehabilitation training is carried out by the rehabilitator in accordance with the established rehabilitation plan. The stimulation of running lasted from 3 months of corrected gestational age to being able to walk alone for 3 steps or to correct for 18 months.', 'armGroupLabels': ['intervention group']}, {'name': 'Conventional physical rehabilitation training', 'type': 'BEHAVIORAL', 'description': 'Suitable for general physical rehabilitation training of all infants with cerebral palsy.', 'armGroupLabels': ['intervention group', 'positive control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Children Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai High-risk Infants Early Intervention Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}