Clinical trial NCT07005440: Functional Training and Dynamic Play Exercise on Gross Motor Skills, Physical Fitness, and Balance in Healthy Children
Official title: Comparison of Functional Training and Dynamic Play Exercise on Gross Motor Skills, Physical Fitness, and Balance in Healthy Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Children
Keywords: Gross motor skills
Physical fitness
Functional training
Dynamic play exercises
Balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 38
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Paediatric Balance Scale
timeFrame: Baseline, 12th week
measure: Test for Gross Motor Development (TGMD-2)
timeFrame: Baseline, 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Zainab Javed, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.