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

NCT03534466 | Terminated DMC

• 1 other identifier: CHFudanU_NNICU9
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

treadmill; infants; neonatal encephalopathy; neonatal brain injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• age of onset of walking with assistance

  The length of time from birth to the corrected age of 2 years

• step length

  The length of time from birth to the corrected age of 18 months

• step width

  The length of time from birth to the corrected age of 18 months

• gait double-limb support

  The length of time from birth to the corrected age of 18 months

• gait ankle plantar flexion

  The length of time from birth to the corrected age of 18 months

Study Arms (2)

intervention group

EXPERIMENTAL

Baby treadmill + conventional physical rehabilitation training

Device: Baby treadmill; Behavioral: Conventional physical rehabilitation training

positive control group

ACTIVE COMPARATOR

Conventional physical rehabilitation training only

Behavioral: Conventional physical rehabilitation training

Interventions

Baby treadmill DEVICE

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.

intervention group

Conventional physical rehabilitation training BEHAVIORAL

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

intervention group; positive control group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai High-risk Infants Early Intervention Center: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (6)

• 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.

  PMID: 26828941 RESULT

• 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.

  PMID: 25782975 RESULT

• 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.

  PMID: 25644966 RESULT

• 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.

  PMID: 25123212 RESULT

• 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.

  PMID: 24136687 RESULT

• 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.

  PMID: 24012586 RESULT

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Leukomalacia, Periventricular; Kernicterus; Hypoglycemia; Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Encephalomalacia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Diseases, Metabolic; Erythroblastosis, Fetal; Hematologic Diseases; Hemic and Lymphatic Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases; Hyperbilirubinemia; Pathologic Processes; Glucose Metabolism Disorders; Brain Infarction; Stroke; Infarction; Ischemia; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: May 23, 2018
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)