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

December 27, 2023 updated by: Children's Hospital of Fudan University
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Baby treadmill + conventional physical rehabilitation training
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.
Active Comparator: positive control group
Conventional physical rehabilitation training only
Behavioral: Conventional physical rehabilitation training
Suitable for general physical rehabilitation training of all infants with cerebral palsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The length of time from birth to the corrected age of 18 months
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.
The length of time from birth to the corrected age of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The length of time from birth to the corrected age of 2 years
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.
The length of time from birth to the corrected age of 18 months
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
The length of time from birth to the corrected age of 18 months
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.
The length of time from birth to the corrected age of 18 months
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.
The length of time from birth to the corrected age of 18 months
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.
The length of time from birth to the corrected age of 18 months
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.
The length of time from birth to the corrected age of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

Shanghai High-risk Infants Early Intervention Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_NNICU9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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