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

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03534466

Collaborator

Shanghai 6F+ High-risk Infants Early Intervention Center (Other)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxic-Ischemic Encephalopathy Periventricular Leukomalacia Intraventricular Hemorrhage Neonatal Bilirubin Encephalopathy Kernicterus Hypoglycemia, Neonatal Cerebral Infarction	Device: Baby treadmill Behavioral: Conventional physical rehabilitation training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group Baby treadmill + conventional physical rehabilitation training	Device: Baby treadmill 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. Behavioral: Conventional physical rehabilitation training Suitable for general physical rehabilitation training of all infants with cerebral palsy.
Active Comparator: positive control group Conventional physical rehabilitation training only	Behavioral: Conventional physical rehabilitation training Suitable for general physical rehabilitation training of all infants with cerebral palsy.

Arm

Intervention/Treatment

Experimental: intervention group

Baby treadmill + conventional physical rehabilitation training

Device: Baby treadmill

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.

Behavioral: Conventional physical rehabilitation training

Suitable for general physical rehabilitation training of all infants with cerebral palsy.

Active Comparator: positive control group

Conventional physical rehabilitation training only

Behavioral: Conventional physical rehabilitation training

Suitable for general physical rehabilitation training of all infants with cerebral palsy.

Outcome Measures

Primary Outcome Measures

step frequency [The length of time from birth to the corrected age of 18 months]
This variable is a number that records the infants' number of coordinated gaits in all gait training processes.
age of onset of independent walking [The length of time from birth to the corrected age of 2 years]
This variable is a gait parameter, recording a point in time the baby will start walking independently.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.