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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03534466
• Other study ID #: CHFudanU_NNICU9
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bilirubin Encephalopathy
• Brain Diseases
• Brain Ischemia
• Cerebral Infarction
• Hemorrhage
• Hypoglycemia
• Hypoglycemia, Neonatal
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Intraventricular Hemorrhage Neonatal
• Kernicterus
• Leukomalacia, Periventricular
• Periventricular Leukomalacia

Intervention

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.

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

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

Country where clinical trial is conducted

China, 

References & Publications (6)

Angulo-Barroso RM, Tiernan C, Chen LC, Valentin-Gudiol M, Ulrich D. Treadmill training in moderate risk preterm infants promotes stepping quality--results of a small randomised controlled trial. Res Dev Disabil. 2013 Nov;34(11):3629-38. doi: 10.1016/j.rid — View Citation

de Klerk CC, Johnson MH, Heyes CM, Southgate V. Baby steps: investigating the development of perceptual-motor couplings in infancy. Dev Sci. 2015 Mar;18(2):270-80. doi: 10.1111/desc.12226. Epub 2014 Aug 13. — View Citation

Madhavan S, Campbell SK, Campise-Luther R, Gaebler-Spira D, Zawacki L, Clark A, Boynewicz K, Kale D, Bulanda M, Yu J, Sui Y, Zhou XJ. Correlation between fractional anisotropy and motor outcomes in one-year-old infants with periventricular brain injury. J — View Citation

Siekerman K, Barbu-Roth M, Anderson DI, Donnelly A, Goffinet F, Teulier C. Treadmill stimulation improves newborn stepping. Dev Psychobiol. 2015 Mar;57(2):247-54. doi: 10.1002/dev.21270. Epub 2015 Feb 2. — View Citation

Teulier C, Lee DK, Ulrich BD. Early gait development in human infants: Plasticity and clinical applications. Dev Psychobiol. 2015 May;57(4):447-58. doi: 10.1002/dev.21291. Epub 2015 Mar 18. — View Citation

Vasudevan EV, Patrick SK, Yang JF. Gait Transitions in Human Infants: Coping with Extremes of Treadmill Speed. PLoS One. 2016 Feb 1;11(2):e0148124. doi: 10.1371/journal.pone.0148124. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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