Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill

Study Overview
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Brief Summary
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There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

Detailed Description
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There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigators will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

Official Title
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A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy

Conditions
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Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage, Bilirubin Encephalopathy, Kernicterus, Hypoglycemia, Neonatal, Cerebral Infarction

Intervention / Treatment
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* Device: Baby treadmill
* Behavioral: Physical rehabilitation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age < 33 weeks; Correction of gestational age < 3 months; It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction. There was no other therapeutic intervention before entering the study; Informed consent is signed by the family. Exclusion Criteria: This study is excluded from the study provided that one of the following conditions is met: Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive); Brain damage caused by convulsion; Metabolic brain damage caused by genetic defects; Suffering from known severe congenital malformations; Definite head trauma during labor or postpartum; Peripheral neuromuscular disease or abnormal skeletal system.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Baby treadmill + physical rehabilitation training | Device: Baby treadmill<br>* 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.<br>Behavioral: Physical rehabilitation training<br>* Suitable for general physical rehabilitation training of all infants with cerebral palsy.<br>|
| Active Comparator: positive control group<br>Physical rehabilitation training only | Behavioral: Physical rehabilitation training<br>* Suitable for general physical rehabilitation training of all infants with cerebral palsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score from Bayley Scales of Infant and Toddler Development testing | These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems. | The length of time from birth to the corrected age of 18 months | 
| fractional anisotropy(FA) | a variable from Diffusion Tensor Image（DTI）sequence of MRI | The length of time from birth to the corrected age of 18 months | 
| the value of Amplitude of Low Frequency Fluctuation(ALFF) | a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI | The length of time from birth to the corrected age of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alberta Infant Motor Development Assessment | Neurodevelopmental evaluation scale | The length of time from birth to the corrected age of 18 months | 
| Peabody motor development scale | The Peabody Developmental Motor Scales (PDMS) is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age. Reflexes (Re), Stationary (St), Locomotion (Lo) , Object Manipulation (Ob), Grasping (Gr), Visual-Motor Integration (Vi). All of the PDMS-2 subtests contribute to a Total Motor Quotient (TMQ). | The length of time from birth to the corrected age of 18 months | 
| Gross Motor Function Measure Scale | There is a 4-point scoring system for each item on the GMFM. Specific descriptors for scoring items are detailed in the administration and scoring guidelines. The GMFM-66 requires a user-friendly computer programme called the Gross Motor Ability Estimator, or GMAE, to enter individual item scores and convert them to an interval level total score. | The length of time from birth to the corrected age of 18 months | 
| the value of regional homogeneity (ReHo) | a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI | Corrected age of 18 months | 
| mean diffusion(MD) | a variable from Diffusion Tensor Image（DTI） sequence of MRI | The length of time from birth to the corrected age of 18 months |