Comparative Effects Of Creative Movement & Play Based Interventions On Motor Skills

May 5, 2026 updated by: Riphah International University

Comparative Effects Of Creative Movement & Play Based Interventions On Motor Skills, Balance And Quality Of Life In Children With Developmental Delay

Children with developmental delay often face challenges in motor skills, balance, and overall quality of life, requiring interventions that are both effective and engaging. The purpose of this study is to improving these areas and investigating comparative effects of both creative movement and play based intervention that can help identify the most effective approach for enhancing motor abilities, balance, and overall well-being in this population

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized clinical trial will assess the effects of Creative Movement and Play-Based Interventions on motor skills, balance, and QoL in children with developmental delays. Data will be collected from special education centers and pediatric rehabilitation clinics. Inclusion criteria will include children aged 5-8 years, both genders, with MMSE >24, Stork Stand >4 seconds, and baseline scores on Pediatric Berg Balance Scale, TGMD-2, BOT-2, and PedsQL. Exclusion criteria will cover neurological or musculoskeletal disorders, uncorrected sensory impairments, behavioral issues like ADHD or autism, and recent surgery or assistive device use. Children with chronic illnesses limiting activity, recent specialized motor training, non-compliance with testing. Participants will be randomly assigned to either a Creative Movement or Play-Based Intervention group. Outcome measures will include the Bruininks-Oseretsky Test of Motor Proficiency, Pediatric Balance Scale, Timed Up and Go Test, and Pediatric Quality of Life Inventory. The data collection procedure systematically organized for two intervention groups: Both groups began each session with a 5-minute baseline warm-up including light aerobic movements, dynamic stretching, and active-assisted ROM exercises. Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination, strength exercises (Grow Strong segment), locomotor games, yoga with breathing, and music-making with instruments. Each session lasted 60 minutes and was conducted twice weekly for 8 weeks. Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts & crafts for fine motor development. Each session concluded with a cool-down, promoting relaxation and emotional regulation. Group A will be Creative Movement Intervention and Group B will be Play-Based Intervention, to study Effects of Creative Movement & Play Based Interventions on MotorSkills, balance and quality of life in Children with Developmental Delay.Data will be analyzed using SPSS version 27 to determine the effectiveness of both interventions in enhancing motor function, balance, and overall quality of life

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 42000
        • Rax clinic iqbal town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

inclusion Criteria

  1. Children aged 5-8 years.
  2. Both girls and boys .
  3. Mini-Mental State Examination (MMSE) score > 24 .
  4. Stork Stand Balance Test (both legs) > 4 seconds .
  5. Pediatric Berg Balance Scale score ≥ 40 .
  6. TGMD-2 GMQ score ≤ 79 (≤ 25th percentile) .
  7. BOT-2 Total Motor Composite score ≤ 18th percentile .
  8. PedsQL total score ≤ 70

Exclusion criteria:

  1. Musculoskeletal Impairments affecting posture.
  2. balance.
  3. Uncorrected visual or auditory impairments .
  4. Behavioral or Attention Disorders that may impair test compliance or affect performance reliability .
  5. Recent Surgery or Injury in the past 6 months .
  6. Use of Assistive Devices .
  7. Chronic Illness Affecting Physical Activity .
  8. Participation in specialized motor training in the past 3 months .
  9. Inability to follow instructions or complete assessments (TGMD-2, BOT-2, PedsQL).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Creative Movement intervention group.
Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination,
Behavioral: creative movement intervention
Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination, strength exercises (Grow Strong segment), locomotor games, yoga with breathing, and music-making with instruments. Each session lasted 60 minutes and was conducted twice weekly for 8 weeks
Experimental: Play-Based intervention group
Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts & crafts for fine motor development. Each session concluded with a cool-down, promoting relaxation and emotional regulation
Behavioral: play based intervention
Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts & crafts for fine motor development. Each session concluded with a cool-down, promoting relaxation and emotional regulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PedsQL.
Time Frame: 8 weeks

Is a standardized, validated tool designed to measure health-related quality of life (HRQOL) in children and adolescents aged 2-18 years. The Turkish validity and reliability tests of the form were performed by Memik et al. (2008). There are other versions of this data collection tool which were developed for different age groups. There is a Likert type answer scale with five answer options: (0 ¼ never, 1 ¼ seldom, 2 ¼ sometimes, 3 ¼ often, 4 ¼ always). The points which are obtained from the items are calculated and a score between 0 and 100 is linearly obtained (0 ¼ 100, 1 ¼ 75, 2 ¼ 50, 3

¼ 25, 4 ¼ 0). A score between 0 and 100 indicates the quality of life score and an increase in the scores means an increase in the quality of life.
8 weeks
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for fine and gross Motor Skills
Time Frame: 8 weeks
Is a widely recognized and reliable tool for evaluating both fine and gross motor skills in children aged 4 to 21 years. The shorter form of the test consists of fourteen subtests, which assess fine motor precision and integration, bilateral coordination, balance, running speed, agility, upper body coordination, and strength. The reliability of all the mentioned items is above 0.70, with overall internal consistency reliability ranging from 0.80 to 0.90, and test-retest reliability reported between 0.80 and 0.87, indicating strong measurement stability. It should be noted that the test validity and reliability were established in a sample of healthy children. The short form includes five fine motor skill tests (Drawing, Lines through Paths-Crooked, Folding Paper, Copying a Square, Copying a Star, Transferring Pennies) and nine gross motor tasks (Jumping in Place-Same Sides Synchronized, Tapping Feet and Fingers-Same Sides Synchronized, Walking Forward on a Line, Standing on
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric Balance Scale PBS for Functional Balance
Time Frame: 8 weeks
Is an adaptation of the Berg Balance Scale and it is a criterion-referenced test assessing functional balance in children 2 years - 7 years and older. It is a valid and reliable balance tool that assesses for functional balance using 14 tasks which are similar to activities of daily living. Within the tasks, the PBS incorporates the conditions similar to the Romberg, Sharpened Romberg, Functional Reach Test and Standing on One Leg test. These tasks can be scored from 0 to 4 where a high score indicates good performance and the test can be completed in approximately 20 min with the aid of easily accessible equipment e.g., chair, bench, stopwatch etc. The PBS has an interrater reliability of (ICC [3, 2] = 0.90-0.92), test-retest (ICC [2,1] = 0.923), and intra-rater reliability (ICC [2,1] = 0.895-0.998) allowing for adequately identifying children with balance dysfunction
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khadija Liaquat, MS, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Riphah IU Yashma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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