Clinical trial NCT03534466: Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
Official title: Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Periventricular Leukomalacia
Intraventricular Hemorrhage Neonatal
Bilirubin Encephalopathy
Kernicterus
Hypoglycemia, Neonatal
Cerebral Infarction
Keywords: treadmill
infants
neonatal encephalopathy
neonatal brain injury
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai High-risk Infants Early Intervention Center
First posted: 2018-05-23
Enrollment: 20
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: step frequency
timeFrame: The length of time from birth to the corrected age of 18 months
measure: age of onset of independent walking
timeFrame: The length of time from birth to the corrected age of 2 years
Secondary outcomes:
measure: age of onset of walking with assistance
timeFrame: The length of time from birth to the corrected age of 2 years
measure: step length
timeFrame: The length of time from birth to the corrected age of 18 months
measure: step width
timeFrame: The length of time from birth to the corrected age of 18 months
measure: gait double-limb support
timeFrame: The length of time from birth to the corrected age of 18 months
measure: gait ankle plantar flexion
timeFrame: The length of time from birth to the corrected age of 18 months
measure: toe-off
timeFrame: The length of time from birth to the corrected age of 18 months
measure: gait ankle dorsiflexion
timeFrame: The length of time from birth to the corrected age of 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
References:
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.
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.
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.
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.
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 Magn Reson Imaging. 2014 Apr;39(4):949-57. doi: 10.1002/jmri.24256. Epub 2013 Oct 17.
citation: 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.