Healthy ChildrenNCT07005440
Functional Training and Dynamic Play Exercise on Gross Motor Skills, Physical Fitness, and Balance in Healthy Children
A study testing Functional Training and Dynamic Play Exercise in people with Healthy Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to explore and compare two distinct approaches to physical activity: functional training and dynamic play exercises, focusing on their effects on children's gross motor skills, physical fitness and balance. A randomized clinical trial will be conducted. 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
- What is being tested?
- Functional Training and Dynamic Play Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Apr 2025to 7 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age 7-10 years
- Both genders
- Cognition MMSE score > 25
- Class grades 2-5
- BMI between 5th - 85th percentiles
- Able to stand and walk independently
Show all 9Show fewer
- PBBS score > 40
- TGMD-2 > 13
- TUDS > 10 secs
Who cannot join
- Pes Planus \& Pes cavus
- Scoliosis
- Genu valgum
- Genu varum
- Juvenile Idiopathic Arthritis
- Presence of Asthma
- Acute orthopedic problem and any history of surgery past 6 months
- Visual, vestibular, or balance disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Muhammad Asif Javed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Comparison of Functional Training and Dynamic Play Exercise on Gross Motor Skills, Physical Fitness, and Balance in Healthy Children
This study aims to explore and compare two distinct approaches to physical activity: functional training and dynamic play exercises, focusing on their effects on children's gross motor skills, physical fitness and balance.
A randomized clinical trial will be conducted. The study will be conducted at Primary school of Lahore in a total duration of 10 months. Sample size will be 38. There will be two groups. Non-probability convenient sampling techniques will be used. The sample having the following characteristics will be included; Age 7-10 years, Both genders, Cognition MMSE score > 25, Class grades 2-5 , BMI between 5th - 85th percentiles, Able to stand and walk independently, PBBS score > 40, TGMD-2 > 13, TUDS > 10 secs. The population having the following characteristics will be excluded from the study; Pes Planus \& Pes cavus, Scoliosis, Genu valgum, Genu varum, Juvenile Idiopathic Arthritis, Presence of Asthma, Acute orthopedic problem and any history of surgery past 6 months, visual, vestibular, or balance disorders. The tools that will be included in this study are: Pediatrics balance scale, Test for gross motor development (TGMD-2) and Time up and downstairs test (TUDS). SPSS version 27 will be used for data analyses.
Read the detailed description
Children's motor development progresses through various milestones such as crawling, walking, and refining fine motor skills, influencing their overall growth and well-being. Piaget's theory underscores the role of motor skills in cognitive and social development, emphasizing that children construct understanding through actions. Motor development, a continuous process, involves gross motor skills (involving large muscles) and fine motor skills (involving small muscles), crucial for daily activities and physical play. Physical fitness in childhood is pivotal for long-term health, correlating with reduced body fat and improved cardio-metabolic health. Balance control, integral to motor skills, depends on sensory inputs and neuromuscular responses. Functional Training and dynamic play are approaches to physical activity that impact gross motor skills, fitness, and balance, with implications for enhancing physical capabilities during childhood. This study aims to explore and compare two distinct approaches to physical activity: functional training and dynamic play exercises, focusing on their effects on children's gross motor skills, physical fitness and balance.
A randomized clinical trial will be conducted. The study will be conducted at Primary school of Lahore in a total duration of 10 months. Sample size will be 38. There will be two groups. Non-probability convenient sampling techniques will be used. The sample having the following characteristics will be included; Age 7-10 years, both genders, cognition MMSE score > 25, Class grades 2-5 , BMI between 5th - 85th percentiles, Able to stand and walk independently, PBBS score > 40, TGMD-2 > 13, TUDS > 10 secs.. The population having the following characteristics will be excluded from the study; Pes Planus \& Pes cavus, Scoliosis, Genu valgum, Genu varum, Juvenile Idiopathic Arthritis, Presence of Asthma, Acute orthopedic problem and any history of surgery past 6 months, visual, vestibular, or balance disorders. The tools that will be included in this study are: Pediatrics balance scale, Test for gross motor development (TGMD-2) and Time up and downstairs test (TUDS).
SPSS version 27 will be used for data analyses.
- Conditions
- Healthy Children
- Being tested
- Functional Training, Dynamic Play Exercise
- Keywords
- Gross motor skills, Physical fitness, Functional training, Dynamic play exercises, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional TrainingOther
Each training session includes a preparation phase (warm-up, neuromuscular activation, dynamic stretching, and core activation), followed by two main modules: motor skill development (walking, jumping, crawling, throwing, pushing, catching) and physical fitness (balance, agility, endurance). Sessions conclude with motor skill consolidation and static stretching. Training spans 12 weeks: once weekly during weeks 1-8, and twice weekly during weeks 9-12
Dynamic Play ExerciseOther
This includes warm-up (for 3-5 mins), rhythmic exercise (5-10 mins), games (7-10 mins) and free play exercises (10-15 mins). This group will receive the lesson once a week during week 1-8 and twice a week during 9-12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Functional Training | Experimental | Group A will perform functional training. Each training session begins with a preparation phase, including warm-up (1-3 min), neuromuscular activation (1-3 min), dynamic stretching (1-3 min), and core muscle activation (1-3 min). The main training phase consists of two modules. The first module is devoted to motor skill development (10-15 mins), with an emphasis on walking, jumping, crawling, throwing, pushing, and catching. The second module focuses on physical fitness (7-10 mins), with an emphasis on balance, agility, and endurance. Each training session concludes with a phase of motor skill consolidation (1-3 min) and static stretching (1-3 min). This group will receive a total 12-week period with one training during 1-8 week and twice a week during 9- 12 weeks Receives: Other: Functional Training; Other: Dynamic Play Exercise |
| Dynamic Play Exercise | Active comparator | Group B will perform dynamic play exercises which includes warm-up (for 3-5 mins), rhythmic exercise (5-10 mins), games (7-10 mins) and free play exercises (10-15 mins). This group will receive the lesson once a week during week 1-8 and twice a week during 9-12 weeks Receives: Other: Functional Training; Other: Dynamic Play Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatric Balance Scale
The Pediatric Balance Scale (PBS), adapted from the Berg Balance Scale, assesses balance in children through 14 items scored 0-4, with a maximum of 56. It shows excellent test-retest (ICC=0.998) and interrater reliability (ICC=0.997).
Measured: Baseline, 12th week
Test for Gross Motor Development (TGMD-2)
The Test of Gross Motor Development-2 (TGMD-2) assesses 12 fundamental movement skills-6 locomotor (e.g., running, hopping) and 6 object control (e.g., throwing, catching)-in children aged 3 to 10 years 11 months. It evaluates movement patterns essential for physical activity. The TGMD-2 shows good internal consistency (α = 0.73-0.87), strong inter-rater agreement (≥ 0.92), and high test-retest reliability (locomotor = 0.91, object control = 0.85).
Measured: Baseline, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start16 Apr 2025
- Primary completion7 Jul 2025 (estimated)
- Study completion7 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomised clinical trial performed, in which 38 children with the age of 7-10 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive Functional training. This group will receive training a total of 12 week period with one training during 1-8 week and twice a week during 9-12 weeks. Group 2 will receive Dynamic play exercises. This group will receive the lesson once a week during week 1-8 and twice a week during 9-12 weeks. Pre values were taken at baseline and post value will be taken after 12th week of intervention to measure the effects of both therapies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab Javed, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005440
- Sponsor's protocol ID
- REC/RCR & AHS/24/0732
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu T, Zhang D, Wang W, Geng H, Lv Y, Shen R, Bu T. Functional Training Focused on Motor Development Enhances Gross Motor, Physical Fitness, and Sensory Integration in 5-6-Year-Old Healthy Chinese Children. Front Pediatr. 2022 Jul 11;10:936799. doi: 10.3389/fped.2022.936799. eCollection 2022.
PubMed 35899135
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Training and Dynamic Play Exercise on Gross Motor Skills, Physical Fitness, and Balance in Healthy Children
- ClinicalTrials.gov ID
- NCT07005440
- Acronym / sponsor ID
- REC/RCR & AHS/24/0732
- Conditions
- Healthy Children
- Keywords
- Gross motor skills, Physical fitness, Functional training, Dynamic play exercises, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 7 Jul 2025 (estimated)
- Study completion
- 7 Jul 2025 (estimated)
- First posted
- 5 Jun 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.
This study aims to explore and compare two distinct approaches to physical activity: functional training and dynamic play exercises, focusing on their effects on children's gross motor skills, physical fitness and balance.
A randomized clinical trial will be conducted. The study will be conducted at Primary school of Lahore in a total duration of 10 months. Sample size will be 38. There will be two groups. Non-probability convenient sampling techniques will be used. The sample having the following characteristics will be included; Age 7-10 years, Both genders, Cognition MMSE score > 25, Class grades 2-5 , BMI between 5th - 85th percentiles, Able to stand and walk independently, PBBS score > 40, TGMD-2 > 13, TUDS > 10 secs. The population having the following characteristics will be excluded from the study; Pes Planus \& Pes cavus, Scoliosis, Genu valgum, Genu varum, Juvenile Idiopathic Arthritis, Presence of Asthma, Acute orthopedic problem and any history of surgery past 6 months, visual, vestibular, or balance disorders. The tools that will be included in this study are: Pediatrics balance scale, Test for gross motor development (TGMD-2) and Time up and downstairs test (TUDS). SPSS version 27 will be used for data analyses.
Detailed description
Children's motor development progresses through various milestones such as crawling, walking, and refining fine motor skills, influencing their overall growth and well-being. Piaget's theory underscores the role of motor skills in cognitive and social development, emphasizing that children construct understanding through actions. Motor development, a continuous process, involves gross motor skills (involving large muscles) and fine motor skills (involving small muscles), crucial for daily activities and physical play. Physical fitness in childhood is pivotal for long-term health, correlating with reduced body fat and improved cardio-metabolic health. Balance control, integral to motor skills, depends on sensory inputs and neuromuscular responses. Functional Training and dynamic play are approaches to physical activity that impact gross motor skills, fitness, and balance, with implications for enhancing physical capabilities during childhood. This study aims to explore and compare two distinct approaches to physical activity: functional training and dynamic play exercises, focusing on their effects on children's gross motor skills, physical fitness and balance.
A randomized clinical trial will be conducted. The study will be conducted at Primary school of Lahore in a total duration of 10 months. Sample size will be 38. There will be two groups. Non-probability convenient sampling techniques will be used. The sample having the following characteristics will be included; Age 7-10 years, both genders, cognition MMSE score > 25, Class grades 2-5 , BMI between 5th - 85th percentiles, Able to stand and walk independently, PBBS score > 40, TGMD-2 > 13, TUDS > 10 secs.. The population having the following characteristics will be excluded from the study; Pes Planus \& Pes cavus, Scoliosis, Genu valgum, Genu varum, Juvenile Idiopathic Arthritis, Presence of Asthma, Acute orthopedic problem and any history of surgery past 6 months, visual, vestibular, or balance disorders. The tools that will be included in this study are: Pediatrics balance scale, Test for gross motor development (TGMD-2) and Time up and downstairs test (TUDS).
SPSS version 27 will be used for data analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Randomised clinical trial performed, in which 38 children with the age of 7-10 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive Functional training. This group will receive training a total of 12 week period with one training during 1-8 week and twice a week during 9-12 weeks. Group 2 will receive Dynamic play exercises. This group will receive the lesson once a week during week 1-8 and twice a week during 9-12 weeks. Pre values were taken at baseline and post value will be taken after 12th week of intervention to measure the effects of both therapies.
| Arm | Type | Receives |
|---|---|---|
| Functional Training | Experimental | Other: Functional Training, Other: Dynamic Play ExerciseGroup A will perform functional training. Each training session begins with a preparation phase, including warm-up (1-3 min), neuromuscular activation (1-3 min), dynamic stretching (1-3 min), and core muscle activation (1-3 min). The main training phase consists of two modules. The first module is devoted to motor skill development (10-15 mins), with an emphasis on walking, jumping, crawling, throwing, pushing, and catching. The second module focuses on physical fitness (7-10 mins), with an emphasis on balance, agility, and endurance. Each training session concludes with a phase of motor skill consolidation (1-3 min) and static stretching (1-3 min). This group will receive a total 12-week period with one training during 1-8 week and twice a week during 9- 12 weeks |
| Dynamic Play Exercise | Active comparator | Other: Functional Training, Other: Dynamic Play ExerciseGroup B will perform dynamic play exercises which includes warm-up (for 3-5 mins), rhythmic exercise (5-10 mins), games (7-10 mins) and free play exercises (10-15 mins). This group will receive the lesson once a week during week 1-8 and twice a week during 9-12 weeks |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 7-10 years
- Both genders
- Cognition MMSE score > 25
- Class grades 2-5
- BMI between 5th - 85th percentiles
Key exclusion criteria (8 listed)
- Pes Planus \& Pes cavus
- Scoliosis
- Genu valgum
- Genu varum
- Juvenile Idiopathic Arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional TrainingEach training session includes a preparation phase (warm-up, neuromuscular activation, dynamic stretching, and core activation), followed by two main modules: motor skill development (walking, jumping, crawling, throwing, pushing, catching) and physical fitness (balance, agility, endurance). Sessions conclude with motor skill consolidation and static stretching. Training spans 12 weeks: once weekly during weeks 1-8, and twice weekly during weeks 9-12 | Other | Dynamic Play Exercise, Functional Training |
| Dynamic Play ExerciseThis includes warm-up (for 3-5 mins), rhythmic exercise (5-10 mins), games (7-10 mins) and free play exercises (10-15 mins). This group will receive the lesson once a week during week 1-8 and twice a week during 9-12 weeks | Other | Dynamic Play Exercise, Functional Training |
Primary outcome
Paediatric Balance Scale
Time frame: Baseline, 12th week
The Pediatric Balance Scale (PBS), adapted from the Berg Balance Scale, assesses balance in children through 14 items scored 0-4, with a maximum of 56. It shows excellent test-retest (ICC=0.998) and interrater reliability (ICC=0.997).
Test for Gross Motor Development (TGMD-2)
Time frame: Baseline, 12th week
The Test of Gross Motor Development-2 (TGMD-2) assesses 12 fundamental movement skills-6 locomotor (e.g., running, hopping) and 6 object control (e.g., throwing, catching)-in children aged 3 to 10 years 11 months. It evaluates movement patterns essential for physical activity. The TGMD-2 shows good internal consistency (α = 0.73-0.87), strong inter-rater agreement (≥ 0.92), and high test-retest reliability (locomotor = 0.91, object control = 0.85).
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 5 Jun 2025.
- Background: PubMed 35899135Fu T, Zhang D, Wang W, Geng H, Lv Y, Shen R, Bu T. Functional Training Focused on Motor Development Enhances Gross Motor, Physical Fitness, and Sensory Integration in 5-6-Year-Old Healthy Chinese Children. Front Pediatr. 2022 Jul 11;10:936799. doi: 10.3389/fped.2022.936799. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Children
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
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.
Zainab Javed, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Training and Dynamic Play Exercise in people with Healthy Children, run by Riphah International University at 1 site in Pakistan.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Paediatric Balance Scale (time frame: Baseline, 12th week). The study lists 2 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 NCT07005440, 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 5 Jun 2025.