Healthy ChildrenNCT06943183
Correlation of Gross Motor Movement, and Balance With Screen Time in Healthy Children
An observational study of Healthy Children, run by Riphah International University.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- How many people
- 429 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2025to 16 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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
- Conditions
- Healthy Children
- Keywords
- Gross motor movement, balance, screen time, school-aged children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start16 Apr 2025 (estimated)
- Primary completion16 Jul 2025 (estimated)
- Study completion16 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahrukh Fatima, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943183
- Sponsor's protocol ID
- REC/RCR/AHS/24/0730
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38578800
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Gross Motor Movement, and Balance With Screen Time in Healthy Children
- ClinicalTrials.gov ID
- NCT06943183
- Acronym / sponsor ID
- REC/RCR/AHS/24/0730
- Conditions
- Healthy Children
- Keywords
- Gross motor movement, balance, screen time, school-aged children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 429 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Apr 2025 (estimated)
- Primary completion
- 16 Jul 2025 (estimated)
- Study completion
- 16 Jul 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 38578800Yuan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahrukh Fatima, MS-PPT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children, run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran amjad, PHD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PBS (Pediatric Berg Balance Scale) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.