Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03534466
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Shanghai 6F+ High-risk Infants Early Intervention Center
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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.

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Periventricular Leukomalacia Intraventricular Hemorrhage Neonatal Bilirubin Encephalopathy Kernicterus Hypoglycemia, Neonatal Cerebral Infarction Device: Baby treadmill Behavioral: Conventional physical rehabilitation training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534466


Contacts
Layout table for location contacts
Contact: Wenhao Zhou, Prof. +86-21-64931003 zhwchfu@126.com
Contact: Kai Yan, Doc. +86-21-64931168 fhyankai@163.com

Locations
Layout table for location information
China, Shanghai
Children Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai 6F+ High-risk Infants Early Intervention Center

Publications of Results:
Layout table for additonal information
Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03534466     History of Changes
Other Study ID Numbers: CHFudanU_NNICU9
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
treadmill
infants
neonatal encephalopathy
neonatal brain injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Diseases
Cerebral Infarction
Brain Ischemia
Hypoxia-Ischemia, Brain
Leukomalacia, Periventricular
Kernicterus
Hypoglycemia
Hemorrhage
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Cerebrovascular Disorders
Stroke
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Brain Diseases, Metabolic
Erythroblastosis, Fetal
Hematologic Diseases
Immune System Diseases
Hyperbilirubinemia