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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04524923
Other study ID # child development
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date February 10, 2021

Study information

Verified date June 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Recent literatures are associating digital technology extensive and addictive use with physical, psychosocial and cognitive inverse consequences. This research focuses more on number of touch screen devices; age started using devices and usage time in relation to cognitive function in preschoolers.


Description:

A hundred typically developing preschool children of both genders with age ranges from three to five years will be included in this study. Visual motor integration, quality of life and cognitive function were assessed by the Peabody Developmental Motor Scale, the Pediatric Quality of Life Inventory™ and the Pediatric Quality of Life Inventory™ cognitive functioning scale respectively Sample size To avoid type II error, sample size calculation was based on data from a pilot study on correlation between touch screen usage time and visual motor integration. Using G*POWER statistica software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [Correlational study, α=0.05, β=0.2, and medium effect size = 0.3] revealed that the appropriate sample size for this study was N=84 Therefore, one-hundred children were recruited for possible dropouts during assessment.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date February 10, 2021
Est. primary completion date February 10, 2021
Accepts healthy volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion criteria: Children were enrolled in this study according to the following criteria: - Age ranges from three to five years. - Both genders were included. Exclusion criteria: Children were excluded from the study if they had any of the following criteria: - Diagnosed with attention deficit/hyperactivity disorder (ADD/ADHD) or developmental co-ordination disorder (DCD). - Preterm children; children with major physical disabilities, genetic disorders; prenatal exposure to alcohol; children with a history of head trauma and infections. - Diagnosed with psychiatric conditions such as autism and depression. - Diagnosed with significant behavioral disorders - Diagnosed with fine motor problems. - Significant auditory or visual deficits.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
visual motor integration
investigate the relation between touch screen usage and visual motor integration in preschoolers
Quality of life assessment
investigate the relation between touch screen usage and Quality of life assessment in preschoolers
Cognitive Functioning
investigate the relation between touch screen usage and Cognitive Functioning assessment in preschoolers

Locations

Country Name City State
Egypt faculty of physical therapy, Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual motor integration The Peabody Developmental Motor Scale will be used to assess visual motor integration. It is a standardized, norm-referenced test used for the assessment of upper limb functions. It is an early childhood motor development program that provides (in one package) both in depth assessment and training of gross and fine motor skills. It can be used by occupational therapists, physical therapists, psychologists, and others who are interested in examining the motor abilities of young children. It is composed of six subtests:-Reflexes (8 items), stationary (30 items), locomotion (89 items), object manipulation (24 items), grasping (25 items) and visual motor integration (72 items). The results of the subtests may be used to generate 3 global indexes of motor performance called (composites). These composites are gross motor quotient, fine motor quotient and total motor quotient with higher scores represent better performance 1 September 2020 to 31 March 2021
Primary Physical and Psychosocial Health The Pediatric quality of life inventory™ generic Arabic parent proxy-report for children from two to five years was used to assess quality of life. It was developed to quantify health- related quality of life (HRQoL) of children and adolescents aged 2-18 years. It consists of 23 questions and evaluate how frequently of a trouble the child has had over the past month. Interpretation of the scale reveals the mean performance as total scale score, physical functioning score (eight questions), emotional functioning score (five questions), social functioning score (five questions) and school function scores (five items). the scores are from 0 to 100 with higher results reflecting better performance. 1 September 2020 to 31 March 2021
Primary cognitive function Pediatric Quality of Life Inventory™ Cognitive Functioning Scale will be used to assess cognitive function. It was developed as a brief generic symptom-specific instrument to measure cognitive functioning. The 6-item scale was designed as a brief and easy-to-administer patient self-reported and parent proxy-reported generic symptom specific instrument to measure cognitive functioning across pediatric populations, originally developed in a pediatric cancer population. The PedsQLTM Cognitive Functioning Scale includes format, instructions, Likert scale from 0 to 100 with higher scores indicating better cognitive function. 1 September 2020 to 31 March 2021
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