- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06198205
Effects of Fundamental Motor Skills Program on Motor and Cognitive Abilities
Effects of Fundamental Motor Skills Program on Motor and Cognitive Abilities in School Going Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah International University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Students will participate in fundamental motor skills(FMS) program that will include 12 basic motor skills.
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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)
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Experimental: Group B
Group B students will do their regular afterschool programs unstructured child's free play
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six minutes Walk test
Time Frame: duration of 8 weeks with 3 sessions per week(total 24 sessions)
|
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.
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duration of 8 weeks with 3 sessions per week(total 24 sessions)
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|
PEDsQL Parent proxy report format
Time Frame: duration of 8 weeks with 3 sessions per week(total 24 sessions)
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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.
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duration of 8 weeks with 3 sessions per week(total 24 sessions)
|
|
The Portage Guide to Early Education
Time Frame: duration of 8 weeks with 3 sessions per week(total 24 sessions)
|
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
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duration of 8 weeks with 3 sessions per week(total 24 sessions)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Asif Javed, MS, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/RCR&AHS/23/0755
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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