Evaluation of Postural Control in Premature Children

Premature Birth Clinical Trial

Official title:

Evaluation of Postural Control in Premature Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562909
• Other study ID #: 09.2020.815
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: March 28, 2021

Study information

• Verified date: January 2021
• Source: Marmara University
• Contact: Ayca Evkaya, Res. Asst.
• Phone: 02166261050
• Email: ayca.evkaya[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 28, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

Brandt T, Schautzer F, Hamilton DA, Brüning 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. Epub 2005 Sep 1. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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