Evaluation of Postural Control in Premature Children

• Conditions: Premature Birth
• Interventions: Device: Neurocom balance master device

• Registration Number: NCT04562909
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-24
• Primary Completion: 2020-11-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20
• Study Completion: 2021-03-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premature children	Neurocom balance master device	Premature children born before than 32 weeks were included.
Healthy Control Group	Neurocom balance master device	Age matched healthy controls

Primary Outcome Measures

Name	Time	Method
Neurocom balance master	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.

Trial Locations

Locations (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey