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

Fudan University

Status: Terminated

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

Treatments: Device: Baby treadmill; Behavioral: Conventional physical rehabilitation training

Study type: Interventional

Funder types: Other

Identifiers

NCT03534466

CHFudanU_NNICU9

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gestational age < 33W;
2. Correction of gestational age < 3 months;
3. It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.
4. There was no other therapeutic intervention before entering the study;
5. Informed consent is signed by the family.

Exclusion criteria

1. Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);
2. Brain damage caused by convulsion;
3. Metabolic brain damage caused by genetic defects;
4. Suffering from known severe congenital malformations;
5. Definite head trauma during labor or postpartum;
6. Peripheral neuromuscular disease or abnormal skeletal system.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

intervention group

Experimental group

Description:

Baby treadmill + conventional physical rehabilitation training

Treatment:

Device: Baby treadmill

Behavioral: Conventional physical rehabilitation training

positive control group

Active Comparator group

Description:

Conventional physical rehabilitation training only

Treatment:

Behavioral: Conventional physical rehabilitation training