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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03534466
Enrollment
20
Registered
2018-05-23
Start date
2020-12-01
Completion date
2021-06-30
Last updated
2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

treadmill, infants, neonatal encephalopathy, neonatal brain injury

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.

Interventions

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.

BEHAVIORALConventional physical rehabilitation training

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

Sponsors

Shanghai High-risk Infants Early Intervention Center
CollaboratorUNKNOWN
Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
step frequencyThe length of time from birth to the corrected age of 18 monthsThis variable is a number that records the infants' number of coordinated gaits in all gait training processes.
age of onset of independent walkingThe length of time from birth to the corrected age of 2 yearsThis variable is a gait parameter, recording a point in time the baby will start walking independently.

Secondary

MeasureTime frameDescription
step widthThe length of time from birth to the corrected age of 18 monthsThe vertical distance between the parallel lines of two medial plantar edges
gait double-limb supportThe length of time from birth to the corrected age of 18 monthsThe percentage of two-limb support gait in the whole training process.
age of onset of walking with assistanceThe length of time from birth to the corrected age of 2 yearsThis variable is a gait parameter, recording a point in time the baby will start walking with assistance.
toe-offThe length of time from birth to the corrected age of 18 monthsThe percentage of toe-off gait in the whole training process.
gait ankle dorsiflexionThe length of time from birth to the corrected age of 18 monthsThe percentage of ankle dorsiflexion gait in the whole training process.
gait ankle plantar flexionThe length of time from birth to the corrected age of 18 monthsThe percentage of gait ankle plantar flexion in the whole training process.
step lengthThe length of time from birth to the corrected age of 18 monthsThe length of displacement formed by the same foot after completing a gait.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026