NCT07005440

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

April 17, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

Gross motor skillsPhysical fitnessFunctional trainingDynamic play exercisesBalance

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Baseline, 12th week

Study Arms (2)

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

Other: Functional TrainingOther: 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

Other: Functional TrainingOther: Dynamic Play Exercise

Interventions

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 ExerciseFunctional Training

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

Dynamic Play ExerciseFunctional Training

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35899135BACKGROUND

Study Officials

  • Zainab Javed, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

June 5, 2025

Study Start

April 16, 2025

Primary Completion

July 7, 2025

Study Completion

July 7, 2025

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations