The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Completed
CT.gov ID
NCT05778357
Collaborator
(none)
75
1
4
18.7

Study Details

Study Description

Brief Summary

Development; It covers the areas of physical, mental, emotional and social development. Development in one area affects other areas as well. Infancy is the period in which children grow and develop the fastest. Babies need many environmental factors and stimulants in order to have a healthy developmental process. For the Covid 19 pandemic, many restrictions have been made in Turkey to reduce the spread of the epidemic and to maintain social distance between people. It has been suggested that individuals practice their own social isolation. It has also caused babies who spend their time at home during the pandemic process to be deprived of environmental stimuli. In current studies in the literature, it has been reported that the COVID-19 pandemic affects infant and child development significantly and negatively. It has been reported that the risk of delay in children who have experienced the COVID-19 pandemic is especially in the fine motor and communication areas. There is a limited number of studies in the literature on this subject. No study was found in Turkey. The aim of this study is to evaluate the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and to reveal the effects of the pandemic process. Denver II Developmental Screening Test was used to evaluate the neuromotor development of healthy infants aged 6-24 months, who applied to the healthy pediatric outpatient clinic of Acıbadem Altunizade Hospital, and Alberta Infant Motor Scale was used to evaluate gross motor functions.

Condition or Disease Intervention/Treatment Phase
  • Other: Group1

Detailed Description

It is an observational study. Purpose of the study: evaluating the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and revealing the effects of the pandemic process.

75 healthy infants aged 6-24 months were included.

  • Will there be developmental delays in children born in the Covid 19 pandemic?

  • In which parameter delay is observed the most.

Denver II Developmental Screenin Test and Alberta Infant Motor Scale were applied to the participants.

Study Design

Study Type:
Observational
Actual Enrollment :
75 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies: A Cross-sectional Study From Turkey
Actual Study Start Date :
Jun 25, 2022
Actual Primary Completion Date :
Oct 25, 2022
Actual Study Completion Date :
Oct 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Evaluation of neuromotor development of healthy infants

75 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.

Other: Group1
75 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.

Outcome Measures

Primary Outcome Measures

  1. Denver II Developmental Screening Test [baseline]

    It is a screening test used in children aged 0-6 years. The test is done in a short time like 5-15 minutes. The person who will administer the Denver II test; must be trained and certified. Standardized test materials are used. The test consists of 4 sections and 134 items. There are personal-social, language, fine motor and gross motor sections. The test result is classified as Normal - Abnormal - Suspicious.

  2. Alberta infant motor scale [baseline]

    It is used to observe gross motor functions and evaluate the effectiveness of the intervention in typically developing infants between 0-18 months. The duration of the test is 10 minutes and consists of 58 items. The child's spontaneous movements are evaluated in 4 different positions without touching the child. 1 point is taken for each item that can be done. A table containing the mean and standard deviation for each month is used. The test result is classified as Normal - Abnormal - Suspicious.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 75 healthy infants aged 6-24 months were included.
Exclusion Criteria:
  • Having a physical/mental/neuromotor/psychological problem

  • Not between 6-24 months in the pandemic process

  • Presence of a diagnosed disease

  • Having a vision problem

  • Having a hearing problem

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acıbadem Altunizade Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Nilay Arman, Istanbul University - Cerrahpasa (IUC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gökçen Erol, MSc Physiotherapist, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05778357
Other Study ID Numbers:
  • GErol
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gökçen Erol, MSc Physiotherapist, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023