NCT06198205

Brief Summary

School age child development is a range from 6 to 12 years of age. During this time period observable differences in height, weight, and build of children may be prominent. The language skills of children continue to grow and many behavior changes occur as they try to find their place among their peers. School-age children gain between four and seven pounds each year., Increases in height will vary, and a three-to-six height difference in age groups is typical. Growth spurts are common in school-age children, as are periods of slow growth. Fundamental Movement Skills (FMS) are a specific set of gross motor skills that involve different body parts. These skills are the building blocks for more complex skills that children will learn throughout their lives. They help children take part in games, sports and recreational activities. While the Motor cognition takes into account the preparation and production of actions, as well as the processes involved in recognizing, predicting, mimicking, and understanding the behavior of other people It will be a randomized controlled trial. This study will include 48 school going children who meet the inclusion criteria will be recruited from Qazi Grammer School, The Cardour School. Two groups will be formed and 24 students will be allocated in each group. Before applying the techniques pre and post reading will be taken.Tools used during our study will be Parent proxy report format and Six minutes Walk test and portage guide to early education. In Group A which will be experimental group Experimental Group students will participate in fundamental motor skills(FMS) program that will include 12 basic motor skills(running,hopping,galloping,leaping,jumping,sliding,strinking,dribbling,catching overhand throwing and underhand rolling) will be applied and Group B which will be control group regular afterschool programs which include unstructured child's free play including sliding, hide and seek, sea-saw, and runing, along with reading, drawing will be used. These activities will continue for 3 sessions per week for the period of 8 weeks. Data will be analyzed by using SPSS for windows version 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Cognition.Fundamental motor skillsSchool going children

Outcome Measures

Primary Outcomes (3)

  • The Portage Guide to Early Education

    The Portage Guide to Early Education is a develop- mentally formulated curriculum to be used with children, either handicapped or normal, between the mental ages of birth to five years. Maximum value of portage guide to early education showed the improvement of the training increased value showed improved motor and cognitive abilities of the patient. Each question's answer of motor and cognitive part of the portage guide to early education was calculated by the formula, Correct answer÷ incorrect answer× 12...then add all the answers of both components and divided it by 2,we divided it by two because in our study we include only two components of this questionnaire instead of all 5

    duration of 8 weeks with 3 sessions per week(total 24 sessions)

  • Six minutes Walk test

    In healthy children, the 6-min walk test is a reliable and valid functional test for assessing exercise tolerance and endurance. An individual's response to exercise is an important clinical assessment tool, since it provides a composite assessment of their respiratory, cardiac and metabolic systems. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance.

    duration of 8 weeks with 3 sessions per week(total 24 sessions)

  • PEDsQL Parent proxy report format

    Parent proxy-report includes ages 2-4 (toddler), 5-7 (young child), 8-12 (child), and 13-18 (adolescent), and assesses parent's perceptions of their child's HRQOL. The items for each of the forms are essentially identical, differing in developmentally appropriate language, or first or third person tense. The PedsQL achieved excellent reliability across scales, and distinguished healthy individuals from those with chronic health conditions, as well as individuals with ASD from those without. Factor analysis confirmed a 5-factor model.

    duration of 8 weeks with 3 sessions per week(total 24 sessions)

Study Arms (2)

Group A

EXPERIMENTAL

Students will participate in fundamental motor skills(FMS) program that will include 12 basic motor skills.

Other: Fundamental motor skills

Group B

EXPERIMENTAL

Group B students will do their regular afterschool programs unstructured child's free play

Other: Regular after school program

Interventions

This will receive fundamental motor skills(FMS) program include 12 basic motor skills(running,hopping,galloping,leaping,jumping,sliding,strinking,dribbling,catching overhand throwing and underhand rolling)

Group A

This group will receive regular afterschool programs unstructured child's free play which include sliding, hide and seek, sea-saw, and running along with reading, drawing. Each intervention session lasted 60 minutes. The study will be conducted in the duration of 8 weeks with 3 sessions per week (total 24 sessions) will be given to the students.

Group B

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: school going children of age between 5 to 6 years.
  • Students who are present at school in their afterschool programs between 12 to 2pm.
  • Gender: both boys and girls.
  • Children who are physically active
  • Children who are able to understand command
  • BMI= Normal to Obese(16.5 - \>28.0).

You may not qualify if:

  • Students with any leg length discrepancy .
  • With any surgical intervention from last 6 months
  • Any history of fracture.
  • Children with flat foot/club foot.
  • Children with genu varum/valgum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Garcia-Hermoso A, Alonso-Martinez AM, Ramirez-Velez R, Perez-Sousa MA, Ramirez-Campillo R, Izquierdo M. Association of Physical Education With Improvement of Health-Related Physical Fitness Outcomes and Fundamental Motor Skills Among Youths: A Systematic Review and Meta-analysis. JAMA Pediatr. 2020 Jun 1;174(6):e200223. doi: 10.1001/jamapediatrics.2020.0223. Epub 2020 Jun 1.

    PMID: 32250414BACKGROUND

Study Officials

  • Muhammad Asif Javed, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: it is a randomized control trial, used to compare Effects of Fundamental Motor Skills Program on Motor and Cognitive Abilities in school going children. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 5, 2023

Primary Completion

February 5, 2024

Study Completion

February 20, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations