Evaluation of Postural Control in Premature Children

NCT ID: NCT04562909

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-03-28

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.

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.

Conditions

Premature Birth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Premature children

Premature children born before than 32 weeks were included.

Neurocom balance master device

Intervention Type: 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

Neurocom balance master device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naime Evrim Karadag-Saygi, Prof

Role: STUDY_DIRECTOR

Marmara University

Locations

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ayca Evkaya, Res. Asst.

Role: CONTACT

ayca.evkaya@gmail.com

02166261050

Naime Evrim Karadag Saygi, Prof

Role: CONTACT

evrimkaradag4@hotmail.com

+90216 625 45 45 ext. 1628

Facility Contacts

Naime Evrim Karadag Saygi, Prof.

Role: primary

evrimkaradag4@hotmail.com

00902166570606 ext. 1628

Ayca Evkaya, Res. Asst.

Role: backup

ayca.evkaya@gmail.com

00902166570606 ext. 1628

References

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.

Reference Type: BACKGROUND

PMID: 25007063 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20634795 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16141283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11133787 (View on PubMed)

Other Identifiers

09.2020.815

Identifier Type: -

Identifier Source: org_study_id