NCT04524923

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

August 21, 2020

Last Update Submit

June 25, 2021

Conditions

Keywords

Cognitive developmentDigital devicesQuality of Life InventoryVisual motor integrationtouch screen usage

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

cohort group

Ninety-seven 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

Other: visual motor integrationOther: Quality of life assessmentOther: Cognitive Functioning

Interventions

investigate the relation between touch screen usage and visual motor integration in preschoolers

cohort group

investigate the relation between touch screen usage and Quality of life assessment in preschoolers

cohort group

investigate the relation between touch screen usage and Cognitive Functioning assessment in preschoolers

cohort group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

This study will be delimited to typically developing preschool children, from both genders, with age ranging from three to five years.

You may qualify if:

  • Children were enrolled in this study according to the following criteria:
  • Age ranges from three to five years.
  • Both genders were included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

Location

Study Officials

  • Amira M El-tohamy, Phd

    Cairo University

    STUDY CHAIR
  • Amira M Mahmoud

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 24, 2020

Study Start

September 1, 2020

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations