Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill

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

Intervention / Treatment
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* Device: Baby treadmill
* Behavioral: Conventional physical rehabilitation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age < 33W; 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: 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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Maximum Age: 3 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Baby treadmill + conventional 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: Conventional physical rehabilitation training<br>* Suitable for general physical rehabilitation training of all infants with cerebral palsy.<br>|
| Active Comparator: positive control group<br>Conventional physical rehabilitation training only | Behavioral: Conventional 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 |
| --- | --- | --- |
| step frequency | This variable is a number that records the infants' number of coordinated gaits in all gait training processes. | The length of time from birth to the corrected age of 18 months | 
| age of onset of independent walking | This variable is a gait parameter, recording a point in time the baby will start walking independently. | The length of time from birth to the corrected age of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age of onset of walking with assistance | This variable is a gait parameter, recording a point in time the baby will start walking with assistance. | The length of time from birth to the corrected age of 2 years | 
| step length | The length of displacement formed by the same foot after completing a gait. | The length of time from birth to the corrected age of 18 months | 
| step width | The vertical distance between the parallel lines of two medial plantar edges | The length of time from birth to the corrected age of 18 months | 
| gait double-limb support | The percentage of two-limb support gait in the whole training process. | The length of time from birth to the corrected age of 18 months | 
| gait ankle plantar flexion | The percentage of gait ankle plantar flexion in the whole training process. | The length of time from birth to the corrected age of 18 months | 
| toe-off | The percentage of toe-off gait in the whole training process. | The length of time from birth to the corrected age of 18 months | 
| gait ankle dorsiflexion | The percentage of ankle dorsiflexion gait in the whole training process. | The length of time from birth to the corrected age of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treadmill, infants, neonatal encephalopathy, neonatal brain injury