Development DelayNCT07307105
Comparative Effects Of Creative Movement & Play Based Interventions On Motor Skills
A study testing creative movement intervention and play based intervention in people with Development Delay, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Development Delay
- What is being tested?
- creative movement intervention and play based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Oct 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-8 years.
- Both girls and boys .
- Mini-Mental State Examination (MMSE) score > 24 .
- Stork Stand Balance Test (both legs) > 4 seconds .
- Pediatric Berg Balance Scale score ≥ 40 .
- TGMD-2 GMQ score ≤ 79 (≤ 25th percentile) .
- BOT-2 Total Motor Composite score ≤ 18th percentile .
- PedsQL total score ≤ 70
Who cannot join
- Musculoskeletal Impairments affecting posture.
- balance.
- Uncorrected visual or auditory impairments .
- Behavioral or Attention Disorders that may impair test compliance or affect performance reliability .
- Recent Surgery or Injury in the past 6 months .
- Use of Assistive Devices .
Show all 9Show fewer
- Chronic Illness Affecting Physical Activity .
- Participation in specialized motor training in the past 3 months .
- Inability to follow instructions or complete assessments (TGMD-2, BOT-2, PedsQL).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Development Delay
- Being tested
- creative movement intervention, play based intervention
- Keywords
- Balance, Quality of life, Motor skills
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creative movement interventionBehavioural
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
play based interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Creative Movement intervention group. | Experimental | Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination, Receives: Behavioral: creative movement intervention |
| Play-Based intervention group | Experimental | 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 Receives: Behavioral: play based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL.
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.
Measured: 8 weeks
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for fine and gross Motor Skills
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
Measured: 8 weeks
Secondary outcomes (1)
Pediatric Balance Scale PBS for Functional Balance
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start26 Oct 2025
- Primary completion1 Feb 2026
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khadija Liaquat, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307105
- Sponsor's protocol ID
- Riphah IU Yashma
- Status last verified
- May 2026
- First submitted
- 14 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Creative Movement & Play Based Interventions On Motor Skills, Balance And Quality Of Life In Children With Developmental Delay
- ClinicalTrials.gov ID
- NCT07307105
- Acronym / sponsor ID
- Riphah IU Yashma
- Conditions
- Development Delay
- Keywords
- Balance, Quality of life, Motor skills
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Oct 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creative Movement intervention group. | Experimental | Behavioral: creative movement interventionGroup A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination, |
| Play-Based intervention group | Experimental | Behavioral: play based interventionGroup 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 |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 5-8 years.
- Both girls and boys .
- Mini-Mental State Examination (MMSE) score > 24 .
- Stork Stand Balance Test (both legs) > 4 seconds .
- Pediatric Berg Balance Scale score ≥ 40 .
Key exclusion criteria (9 listed)
- Musculoskeletal Impairments affecting posture.
- balance.
- Uncorrected visual or auditory impairments .
- Behavioral or Attention Disorders that may impair test compliance or affect performance reliability .
- Recent Surgery or Injury in the past 6 months .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creative movement interventionGroup 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 | Behavioural | Creative Movement intervention group. |
| play based interventionGroup 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 | Behavioural | Play-Based intervention group |
Primary outcome
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.
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
1 secondary outcome
Pediatric Balance Scale PBS for Functional Balance
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khadija Liaquat, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creative movement intervention and play based intervention in people with Development Delay, 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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
PedsQL. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.