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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 31, 2022

Interventions

• 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.

Arms, Groups and Cohorts

• Experimental: intervention group
  • Baby treadmill + conventional physical rehabilitation training
• Active Comparator: positive control group
  • Conventional physical rehabilitation training only

Clinical Trial Outcome Measures

Primary Measures

• step frequency
  • Time Frame: 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
  • Time Frame: 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 Measures

• age of onset of walking with assistance
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: The length of time from birth to the corrected age of 18 months
  • The percentage of ankle dorsiflexion gait in the whole training process.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 3 Months

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Children’s Hospital of Fudan University
• Collaborator
  • Shanghai 6F+ High-risk Infants Early Intervention Center
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Wenhao Zhou, Prof., +86-21-64931003, zhwchfu@126.com

Citations Reporting on Results

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.

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.

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.

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.

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 Magn Reson Imaging. 2014 Apr;39(4):949-57. doi: 10.1002/jmri.24256. Epub 2013 Oct 17.

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.ridd.2013.07.037. Epub 2013 Sep 4.