NCT04562909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

September 21, 2020

Last Update Submit

January 17, 2021

Conditions

Premature Birth

Keywords

prematurepostural controlbalance

Outcome Measures

Primary Outcomes (1)

  • Neurocom balance master

    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.

    Day 0

Study Arms (2)

Premature children

Premature children born before than 32 weeks were included.

Device: Neurocom balance master device

Healthy Control Group

Age matched healthy controls

Device: Neurocom balance master device

Interventions

Neurocom balance master deviceDEVICE

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 GroupPremature children

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Premature and healthy children

You may qualify if:

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

You may not qualify if:

  • Not giving an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Aylward GP. Neurodevelopmental outcomes of infants born prematurely. J Dev Behav Pediatr. 2014 Jul-Aug;35(6):394-407. doi: 10.1097/01.DBP.0000452240.39511.d4.

    PMID: 25007063BACKGROUND

  • Stoinska B, Gadzinowski J. Neurological and developmental disabilities in ELBW and VLBW: follow-up at 2 years of age. J Perinatol. 2011 Feb;31(2):137-42. doi: 10.1038/jp.2010.75. Epub 2010 Jul 15.

    PMID: 20634795BACKGROUND

  • Brandt T, Schautzer F, Hamilton DA, Bruning R, Markowitsch HJ, Kalla R, Darlington C, Smith P, Strupp M. Vestibular loss causes hippocampal atrophy and impaired spatial memory in humans. Brain. 2005 Nov;128(Pt 11):2732-41. doi: 10.1093/brain/awh617. Epub 2005 Sep 1.

    PMID: 16141283BACKGROUND

  • Allin M, Matsumoto H, Santhouse AM, Nosarti C, AlAsady MH, Stewart AL, Rifkin L, Murray RM. Cognitive and motor function and the size of the cerebellum in adolescents born very pre-term. Brain. 2001 Jan;124(Pt 1):60-6. doi: 10.1093/brain/124.1.60.

    PMID: 11133787BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Naime Evrim Karadag-Saygi, Prof

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

Ayca Evkaya, Res. Asst.

CONTACT

02166261050ayca.evkaya@gmail.com

Naime Evrim Karadag Saygi, Prof

CONTACT

+90216 625 45 45evrimkaradag4@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 24, 2020

Study Start

September 1, 2020

Primary Completion

November 1, 2020

Study Completion

March 28, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)