Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Tre… (NCT03534466) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
Stopped: 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.
China20 participantsStarted 2020-12-01
Plain-language summary
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.
Who can participate
Age range3 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
✕
What they're measuring
1
step frequency
Timeframe: The length of time from birth to the corrected age of 18 months
2
age of onset of independent walking
Timeframe: The length of time from birth to the corrected age of 2 years