- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943183
Correlation of Gross Motor Movement, and Balance With Screen Time in Healthy Children
Study Overview
Status
Conditions
Detailed Description
This study aims to examine the impact of screen time on gross motor development in school-aged children. Gross motor function, which involves large muscle control for activities such as walking, running, and sports, plays a vital role in developing balance, coordination, and overall physical health. With increased screen use among children, physical activity levels may decrease, potentially affecting their motor development.
A cross-sectional study will be conducted over 10 months in public and private schools across Lahore. The target population includes children aged 7 to 10 years. Screen time exposure will be recorded through demographic questionnaires, and gross motor skills will be assessed using the Test of Gross Motor Development-Second Edition (TGMD-2). Children will be excluded if they have a Pediatric Balance Scale (PBS) score below 20, a TGMD-2 score below 30, recent orthopedic surgery, or a Mini-Mental State Examination (MMSE) score below 26. Data will be analyzed using SPSS version 25 with descriptive statistics and correlation tests. This study seeks to identify how screen time may influence key aspects of children's physical development, particularly focusing on gross motor skills and balance
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PBS (Pediatric Berg Balance Scale)
Time Frame: baseline
|
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
Time Frame: baseline
|
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)
Time Frame: baseline
|
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
Time Frame: baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahrukh Fatima, MS-PPT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/RCR/AHS/24/0730
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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