NCT06943183

Brief Summary

Gross motor function involves large muscle control for activities like walking, running, and sports, and is essential for balance and coordination. Excessive screen time may hinder gross motor development by reducing physical activity, affecting strength and coordination. Structured activities like free play and exercise are key to minimizing these effects. A cross-sectional study will be conducted over 10 months in public and private schools in Lahore. Children aged 7-10 will be included. Screen time will be assessed through demographic data, and gross motor skills evaluated using the TGMD-2. Exclusion criteria: PBS \< 20, TGMD-2 \< 30, recent orthopedic surgery, and MMSE \< 26. Data will be analyzed in SPSS v25 using descriptive statistics and correlation. This study explores the impact of screen time on children's physical development, particularly gross motor skills and balance

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
429

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Study Start

First participant enrolled

April 16, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 17, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Gross motor movementbalancescreen timeschool-aged children

Outcome Measures

Primary Outcomes (4)

  • PBS (Pediatric Berg Balance Scale)

    The Pediatric Balance Scale (PBS) is a modified version of Berg's Balance Scale, designed for school-aged children with mild to moderate motor difficulties. In a study by Bal et al., 20 children (ages 5-15) with balance disorders were tested twice by the same examiner. Additionally, 10 pediatric physical therapists, unaware of the study hypotheses, rated 10 randomly chosen sessions. The PBS showed excellent reliability, with high test-retest (ICC = 0.998) and interrater (ICC = 0.997) consistency, confirming its effectiveness as a reliable balance assessment tool for this population

    baseline

  • Screen Time Questionnaire

    The Pediatric Balance Scale (PBS), a modified Berg's Balance Scale, is for school-aged children with mild to moderate motor difficulties. In a study by Bal et al., 20 children (ages 5-15) were tested twice by the same examiner, and 10 pediatric physical therapists rated 10 randomly chosen sessions. PBS showed high test-retest (ICC = 0.998) and interrater reliability (ICC = 0.997), confirming its effectiveness as a reliable balance assessment tool

    baseline

  • TGMD-2 (Test of Gross Motor Development-2)

    The Test of Gross Motor Development-Second Edition (TGMD-2) evaluates children's motor skills. A study assessed the Portuguese version for clarity, validity, and reliability. Two trials per child were video recorded for analysis. The motor tasks were found clear and reflective of motor development. The test showed good validity (Chi-square/df = 3.38; GFI = 0.95; AGFI = 0.92; TLI = 0.83) and strong reliability (locomotor: r = 0.82; object control: r = 0.88).

    baseline

  • kinovea software

    Kinovea is a non-invasive, cost-effective tool for assessing thoracic kyphosis and lumbar lordosis. In a study with 18 participants, its measurements were compared to Cobb's method. Inter- and intra-rater reliability showed moderate to perfect agreement (ICC \< 0.001). Validity for thoracic kyphosis was moderate and dependent on evaluator expertise, while lumbar lordosis showed weaker correlation. Kinovea proves useful for clinical and research-based postural assessments

    baseline

Study Arms (1)

healthy children

The healthy children group will include school-aged children between 7 to 10 years with no known neurological, musculoskeletal, or developmental disorders. All participants will have normal cognitive function (MMSE ≥ 26) and PBS scores above 20, indicating mild or no motor difficulties.

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of children aged 7 to 10 years enrolled in public and private schools in Lahore. Participants must be able to follow basic instructions and engage in physical tasks required for assessment. Children with a Pediatric Balance Scale (PBS) score below 20, TGMD-2 score below 30, a history of orthopedic surgery within the past 6 months, or a Mini-Mental State Examination (MMSE) score below 26 will be excluded. The sample will represent typically developing school-aged children with varying levels of screen time exposure

You may qualify if:

  • Children between ages 7 to 10 years
  • Children with screen time exposure of more than 2 hours per day on a weekday (30,
  • Screen time exposure through television, smartphones, tablets, laptops or computers.
  • Children with exposure of screen time more than 3 hours on a weekend

You may not qualify if:

  • Children with Pediatric balance score: below 45.
  • Children with TGMD-2 Score: below 30 (less than 10" percentile).
  • Children who have had orthopedic surgery within the previous 6 months.
  • Cognition Score below 26 on MMSE (Mini-Mental State Examination).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yuan R, Zhang J, Song P, Qin L. The relationship between screen time and gross motor movement: A cross-sectional study of pre-school aged left-behind children in China. PLoS One. 2024 Apr 5;19(4):e0296862. doi: 10.1371/journal.pone.0296862. eCollection 2024.

    PMID: 38578800BACKGROUND

Study Officials

  • Mahrukh Fatima, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif javed, MS-PT

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 16, 2025

Primary Completion

July 16, 2025

Study Completion

July 16, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share