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Child DevelopmentNCT06198205

Effects of Fundamental Motor Skills Program on Motor and Cognitive Abilities

A study testing Fundamental motor skills and Regular after school program in people with Child Development, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 6 years
Conditions the study is for
Child Development
What is being tested?
Fundamental motor skills and Regular after school program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 sitePakistan
Study dates
5 Dec 2023to 20 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

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 5 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Fundamental Motor Skills Program on Motor and Cognitive Abilities in School Going Children

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.

Read the detailed description

This study will be a randomized controlled trial, used to compare the effects of 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. Assessment will be done by using The Portage Guide to Early Education, Six minutes Walk test and PEDsQL Parent proxy report format. Subjects in group A will be participated in fundamental motor skills(FMS) program and subjects in group B will be participated in regular after school programs unstructured child's free play.

Being tested
Fundamental motor skills, Regular after school program
Keywords
Cognition., Fundamental motor skills, School going children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fundamental motor skillsOther

    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)

  • Regular after school programOther

    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.

Study groups in NCT06198205
Study groupRoleWhat they receive
Group AExperimentalStudents will participate in fundamental motor skills(FMS) program that will include 12 basic motor skills.
Receives: Other: Fundamental motor skills
Group BExperimentalGroup B students will do their regular afterschool programs unstructured child's free play
Receives: Other: Regular after school program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start5 Dec 2023
  3. Primary completion5 Feb 2024
  4. Study completion20 Feb 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06198205
Sponsor's protocol ID
REC/RCR&AHS/23/0755
Status last verified
Jun 2024
First submitted
26 Dec 2023
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32250414

Questions about this trial

What is this clinical trial studying?

A study testing Fundamental motor skills and Regular after school program in people with Child Development, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Portage Guide to Early Education (time frame: duration of 8 weeks with 3 sessions per week(total 24 sessions)). The study lists 3 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 NCT06198205, 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 13 Jun 2024.

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