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Evaluation of Postural Control in Premature Children

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ClinicalTrials.gov Identifier: NCT04562909
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Marmara University

Study Description
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Brief Summary:
To date, it is largely unknown whether preterm children experience balance problems and whether they have normal postural control. Assuming that postural adaptation is affected after preterm delivery because it depends on attention and fine motor control, the postural control and motor development of children born preterm less than 32 weeks in the 5-7 age period will be affected compared to their healthy controls. Identifying these situations according to their healthy peers will improve the general health of premature births and enable better intervention methods to be designed.

Condition or disease Intervention/treatment
Premature Birth Device: Neurocom balance master device

Detailed Description:
Thanks to modern technical interventions and trained health personnel, the survival rate of premature babies has increased significantly in recent years. Neurodevelopmental abnormalities increase as birth weight and gestational week decrease and the presence of adverse biological conditions add up. Brain structures involved in fine motor control, such as the cerebellum, basal ganglia, corpus callosum, amygdala, and hippocampus, are smaller in babies born preterm, even without premature brain damage. Many of the problems associated with these in children are often difficult to detect at an early age, so numerous symptoms may not be detected until school age. In this sense, making periodic assessments of the progress in each child's motor development is essential to identifying deficiencies and thus facilitates referral to early intervention programs.
Study Design
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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Postural Control in Premature Children
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 28, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Premature children
Premature children born before than 32 weeks were included.
 Device: Neurocom balance master device
With the Modified Sensory Balance Interaction Clinical Test, the static balance will be examined by measuring the torso oscillation velocities while the eyes are open and the eyes closed on the stable rigid and unstable foam floors, and the dynamic balance will be examined with the sit-stand test, which is the basic motor activity in daily life, and the parameters will be measured on the same device.
Healthy Control Group
Age matched healthy controls
 Device: Neurocom balance master device
With the Modified Sensory Balance Interaction Clinical Test, the static balance will be examined by measuring the torso oscillation velocities while the eyes are open and the eyes closed on the stable rigid and unstable foam floors, and the dynamic balance will be examined with the sit-stand test, which is the basic motor activity in daily life, and the parameters will be measured on the same device.


Outcome Measures
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Primary Outcome Measures :
  1. Neurocom balance master [ Time Frame: Day 0 ]
    With the Modified Sensory Balance Interaction Clinical Test, the static balance will be examined by measuring the torso oscillation velocities while the eyes are open and the eyes closed on the stable rigid and unstable foam floors, and the dynamic balance will be examined with the sit-stand test, which is the basic motor activity in daily life, and the parameters will be measured on the same device.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Premature and healthy children
Criteria

Inclusion Criteria:

  • Premature children born less than 32 weeks
  • Age between 5-7 years
  • Neurological development to be normal
  • Giving an informed consent

Exclusion Criteria:

  • Not giving an informed consent
Contacts and Locations
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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): NCT04562909


Contacts
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Contact: Ayca Evkaya, Res. Asst. 02166261050 ayca.evkaya@gmail.com
Contact: Naime Evrim Karadag Saygi, Prof +90216 625 45 45 ext 1628 evrimkaradag4@hotmail.com

Locations
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Turkey
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Recruiting
Istanbul, Turkey, 34890
Contact: Naime Evrim Karadag Saygi, Prof.    00902166570606 ext 1628    evrimkaradag4@hotmail.com   
Contact: Ayca Evkaya, Res. Asst.    00902166570606 ext 1628    ayca.evkaya@gmail.com   
Principal Investigator: Ayca Evkaya, Res. Asst.         
Principal Investigator: Hülya Özdemir, Assoc.Prof.         
Sponsors and Collaborators
Marmara University
Investigators
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Study Director: Naime Evrim Karadag-Saygi, Prof Marmara University
More Information
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Publications:

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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT04562909    
Other Study ID Numbers: 09.2020.815
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
premature
postural control
balance
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications