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

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baby treadmill
Conventional physical rehabilitation training
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxic-Ischemic Encephalopathy focused on measuring treadmill, infants, neonatal encephalopathy, neonatal brain injury

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

positive control group

Arm Description

Baby treadmill + conventional physical rehabilitation training

Conventional physical rehabilitation training only

Outcomes

Primary Outcome Measures

step frequency
This variable is a number that records the infants' number of coordinated gaits in all gait training processes.
age of onset of independent walking
This variable is a gait parameter, recording a point in time the baby will start walking independently.

Secondary Outcome Measures

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.
step length
The length of displacement formed by the same foot after completing a gait.
step width
The vertical distance between the parallel lines of two medial plantar edges
gait double-limb support
The percentage of two-limb support gait in the whole training process.
gait ankle plantar flexion
The percentage of gait ankle plantar flexion in the whole training process.
toe-off
The percentage of toe-off gait in the whole training process.
gait ankle dorsiflexion
The percentage of ankle dorsiflexion gait in the whole training process.

Full Information

First Posted
February 22, 2018
Last Updated
September 19, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai High-risk Infants Early Intervention Center
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1. Study Identification

Unique Protocol Identification Number
NCT03534466
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai High-risk Infants Early Intervention Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal, Bilirubin Encephalopathy, Kernicterus, Hypoglycemia, Neonatal, Cerebral Infarction
Keywords
treadmill, infants, neonatal encephalopathy, neonatal brain injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Baby treadmill + conventional physical rehabilitation training
Arm Title
positive control group
Arm Type
Active Comparator
Arm Description
Conventional physical rehabilitation training only
Intervention Type
Device
Intervention Name(s)
Baby treadmill
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Conventional physical rehabilitation training
Intervention Description
Suitable for general physical rehabilitation training of all infants with cerebral palsy.
Primary Outcome Measure Information:
Title
step frequency
Description
This variable is a number that records the infants' number of coordinated gaits in all gait training processes.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
age of onset of independent walking
Description
This variable is a gait parameter, recording a point in time the baby will start walking independently.
Time Frame
The length of time from birth to the corrected age of 2 years
Secondary Outcome Measure Information:
Title
age of onset of walking with assistance
Description
This variable is a gait parameter, recording a point in time the baby will start walking with assistance.
Time Frame
The length of time from birth to the corrected age of 2 years
Title
step length
Description
The length of displacement formed by the same foot after completing a gait.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
step width
Description
The vertical distance between the parallel lines of two medial plantar edges
Time Frame
The length of time from birth to the corrected age of 18 months
Title
gait double-limb support
Description
The percentage of two-limb support gait in the whole training process.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
gait ankle plantar flexion
Description
The percentage of gait ankle plantar flexion in the whole training process.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
toe-off
Description
The percentage of toe-off gait in the whole training process.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
gait ankle dorsiflexion
Description
The percentage of ankle dorsiflexion gait in the whole training process.
Time Frame
The length of time from birth to the corrected age of 18 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhao Zhou, Prof.
Phone
+86-21-64931003
Email
zhwchfu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Yan, Doc.
Phone
+86-21-64931168
Email
fhyankai@163.com
Facility Information:
Facility Name
Children Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhao Zhou, Doctor
Phone
(+86)021-64931003
Email
zwhchfu@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26828941
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.
Results Reference
result
PubMed Identifier
25782975
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.
Results Reference
result
PubMed Identifier
25644966
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.
Results Reference
result
PubMed Identifier
25123212
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.
Results Reference
result
PubMed Identifier
24136687
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.
Results Reference
result
PubMed Identifier
24012586
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.
Results Reference
result

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

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