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Hypoxic-Ischemic EncephalopathyNCT03534466

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

A study testing Baby treadmill and Conventional physical rehabilitation training in people with Hypoxic-Ischemic Encephalopathy and Periventricular Leukomalacia, run by Children's Hospital of Fudan University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 3 months
What is being tested?
Baby treadmill and Conventional physical rehabilitation training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Dec 2020to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Children Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

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.

Being tested
Baby treadmill, Conventional physical rehabilitation training
Keywords
treadmill, infants, neonatal encephalopathy, neonatal brain injury
Medical subject headings
Hypoxia-Ischemia, Brain, Leukomalacia, Periventricular, Kernicterus, Hypoglycemia, Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baby treadmillDevice

    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.

  • Conventional physical rehabilitation trainingBehavioural

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

Study groups in NCT03534466
Study groupRoleWhat they receive
intervention groupExperimentalBaby treadmill + conventional physical rehabilitation training
Receives: Device: Baby treadmill; Behavioral: Conventional physical rehabilitation training
positive control groupActive comparatorConventional physical rehabilitation training only
Receives: Behavioral: Conventional physical rehabilitation training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. step frequency

    This variable is a number that records the infants' number of coordinated gaits in all gait training processes.

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

  2. age of onset of independent walking

    This variable is a gait parameter, recording a point in time the baby will start walking independently.

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

Secondary outcomes (7)

  1. 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.

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

  2. step length

    The length of displacement formed by the same foot after completing a gait.

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

  3. step width

    The vertical distance between the parallel lines of two medial plantar edges

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

  4. gait double-limb support

    The percentage of two-limb support gait in the whole training process.

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

  5. gait ankle plantar flexion

    The percentage of gait ankle plantar flexion in the whole training process.

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

  6. toe-off

    The percentage of toe-off gait in the whole training process.

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

  7. gait ankle dorsiflexion

    The percentage of ankle dorsiflexion gait in the whole training process.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018
  2. Study start1 Dec 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Why it stopped: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
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
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03534466
Sponsor's protocol ID
CHFudanU_NNICU9
Status last verified
Dec 2023
First submitted
22 Feb 2018
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26828941

  • 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.

    PubMed 25782975

  • 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.

    PubMed 25644966

  • 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.

    PubMed 25123212

  • 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.

    PubMed 24136687

  • 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.

    PubMed 24012586

Questions about this trial

What is this clinical trial studying?

A study testing Baby treadmill and Conventional physical rehabilitation training in people with Hypoxic-Ischemic Encephalopathy and Periventricular Leukomalacia, run by Children's Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

step frequency (time frame: The length of time from birth to the corrected age of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03534466, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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