Developmental Delay (Disorder)MINDGAMENCT07575165
Mindful Movement And GAME BASED Training In Developmental Delay
A study testing Mindful movement and Game based training in people with Developmental Delay (Disorder), run by Riphah International University at 1 site in Pakistan.
Trial summary
Developmental delay in children is characterized by delayed acquisition of cognitive, motor, language, and social skills and is commonly associated with conditions such as cerebral palsy, autism spectrum disorder, and genetic disorders. Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Developmental Delay (Disorder)
- What is being tested?
- Mindful movement and Game based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to 30 Aug 2026
- 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 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 9-11 years
- Both male and female
- Children diagnosed with developmental delay by Pediatric neurologist
- Mini mental state examination >24
- Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): 31-40
- Pediatric Berg Balance Scale (PBS) score of less than 45
Show all 9Show fewer
- Functional Reach Test (FRT): 6-7 inches
- Observational Gait Scale (OGS): 0-3, >10
- Edinburgh Visual Gait Score (EVGS): < 37
Who cannot join
- Any cognitive impairment that limits understanding of instructions
- Uncontrolled seizures or medical conditions that contraindicate therapy
- Participation in other structured physiotherapy programs targeting motor skills, gait and balance
- Children with severe visual or hearing impairments affecting the ability to follow intervention activities .
- Children with recent lower-limb orthopedic injuries, fractures, or surgeries within the previous 6 months.
- Children with diagnosed genetic neuromuscular disorders associated with progressive motor deterioration (e.g., muscular dystrophy).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Rehabilitation Center, Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Effects Of Mindful Movement And Game Based Training On Motor Skills, Balance And Gait In Children With Developmental Delay
Developmental delay in children is characterized by delayed acquisition of cognitive, motor, language, and social skills and is commonly associated with conditions such as cerebral palsy, autism spectrum disorder, and genetic disorders. Children with developmental delay frequently experience impairments in motor skills, balance, and gait, which negatively a ffect their functional independence and social participation. Addressing these motor deficits is essential to enhance their quality of life.
Mindful movement and game-based training are two therapeutic approaches that have shown potential in improving motor performance in this population. Mindful movement emphasizes slow, controlled movements, body awareness, emotional regulation, imaginative play, and biomechanical warm-up exercises to enhance motor control. In contrast, game-based training employs engaging and interactive activities to improve motor coordination, balance, strength, and social interaction.
This randomized clinical trial aims to compare the effects of mindful movement and game-based training in children with developmental delay. The study will be conducted at Acme Hospital over a 10-month period and will include 36 children aged 9-11 years selected through non-probability convenient sampling. Participants will be assigned into two groups: Group A will receive mindful movement therapy, and Group B will undergo game-based training. Outcomes will be assessed using validated tools, including the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Pediatric Berg Balance Scale (PBS), Functional Reach Test (FRT), Observational Gait Scale (OGS), and Edinburgh Visual Gait Score (EVGS), to evaluate motor skills, balance, gait, and overall motor proficiency.
Read the detailed description
Developmental delay in children is characterized by a delay in cognitive, motor, language, and social skills development. It can be associated with conditions like cerebral palsy, autism spectrum disorder (ASD), and genetic disorders. Children with developmental delay often struggle with motor skills, balance, and gait, which can impair their ability to perform everyday tasks and engage socially. Addressing these issues is essential for improving their quality of life. Mindful movement and game-based training are two promising therapeutic interventions. Mindful movement, including practices like imaginative and reflective play, biomechanical warm ups improves motor skills by focusing on slow, deliberate movements, body awareness, and emotional regulation. Game-based training, on the other hand, uses engaging and interactive activities to enhance motor coordination, balance, and strength, while also fostering social interaction and cognitive development. This study is a randomized clinical trial to assess the effects of two interventions-mindful movement and game-based training-on children with developmental delay. It will be conducted at Acme Hospital, over a 10 month period. The study will involve 36 children aged 9-11 years, diagnosed with developmental delay, and will employ non-probability convenient sampling. The participants will be divided into two groups: Group A will receive mindful movement therapy, while Group B will undergo game-based training. Data will be collected using several assessment tools, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): 31-40 (22).Pediatric Berg Balance Scale (PBS) score of less than 45 (23). Functional Reach Test (FRT): 6-7 inches (22). Observational Gait Scale (OGS): >10 (22). Edinburgh Visual Gait Score (EVGS): <37. all of which have demonstrated strong reliability and validity. These tools will evaluate motor skills, balance, gait, and overall motor proficiency in the children.
- Conditions
- Developmental Delay (Disorder)
- Being tested
- Mindful movement, Game based training
- Keywords
- Developmental Delay Mindful Movement Game-Based Training
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful movementBehavioural
The intervention includes biomechanical warm-up exercises, imaginative play, animal-based movements, and reflective activities to enhance body awareness, posture, focus, and relaxation. Emphasis is placed on slow, controlled movements to promote mindfulness and overall physical and mental well-being. Each session will last 30-45 minutes, conducted two times per week, total 12 weeks.
Components include:
Biomechanical warm-ups: Gentle joint mobility exercises such as shoulder circles and slow marching (5-10 minutes).
Imaginative play: Creative movement activities (e.g., tree pose with storytelling, emotion walks, butterfly hands) , Animal walks(bear walk, cat walk) to improve strength, coordination, and balance (approximately 30 minutes).
Reflection and cool down: Mirror movements (walk) and "balloon hands" using slow, controlled hand movements to promote relaxation and control breathing.(5 minutes)
Game based trainingBehavioural
The intervention emphasizes active participation, enjoyment, and cognitive engagement. Each session will last 30-45 minutes, conducted two times per week, total 12 weeks.
Components include:
Warm-up: Walking activities to increase body temperature (5-10 minutes).
Main practice: Game-based aerobic, strength, balance, and coordination activities such as The Sea, The Astronauts, Give Your Ball, and The Game of Colors (approximately 30 minutes).
Cool-down: Deep breathing exercises to promote relaxation and reduce heart rate (5 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Mindful Movement Intervention | Experimental | Participants in Arm A will receive a mindful movement program aimed at improving motor skills, balance, coordination, and emotional regulation. Receives: Behavioral: Mindful movement |
| Arm B: Game-Based Training Intervention | Experimental | Participants in Arm B will receive a game-based training program designed to improve motor skills, balance, gait, strength, and overall fitness through engaging and age-appropriate games . Receives: Behavioral: Game based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Skill Performance
Tool: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Outcome: Change in BOT-2 total motor composite score The BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition) scoring converts raw scores into precise motor proficiency metrics for ages 4-21, using sex-specific norms.
Measured: Baseline and 12 weeks
Balance Ability
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
Measured: Baseline and 12 weeks
Gait Quality
Tools: Observational Gait Scale (OGS); The Observational Gait Scale (OGS) is a validated tool used to assess gait quality, particularly in children with cerebral palsy, by scoring key kinematic parameters from video or direct observation. It rates 8 specific gait components in the sagittal plane-including knee position, foot contact, and heel rise-resulting in a maximum score of 22 per limb. Lower scores indicate greater impairments
Measured: Baseline and 12 weeks
Edinburgh Gait Scale
The Edinburgh Visual Gait Score (EVGS) is a comprehensive, video-based observational tool used to assess gait abnormalities, primarily in children with cerebral palsy (CP). It evaluates 17 parameters per limb across sagittal and coronal planes-focusing on the foot, knee, hip, pelvis, and trunk-using a 3-point ordinal scale (0=normal, 1=mild/moderate, 2=severe).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Delay (Disorder)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimra Javed, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575165
- Sponsor's protocol ID
- RCR & AHS/25/0709/Nimra Javed
- Acronym
- MINDGAME
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Mindful Movement And Game Based Training On Motor Skills, Balance And Gait In Children With Developmental Delay
- ClinicalTrials.gov ID
- NCT07575165
- Acronym / sponsor ID
- MINDGAME / RCR & AHS/25/0709/Nimra Javed
- Conditions
- Developmental Delay (Disorder)
- Keywords
- Developmental Delay Mindful Movement Game-Based Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 8 May 2026 (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.
Developmental delay in children is characterized by delayed acquisition of cognitive, motor, language, and social skills and is commonly associated with conditions such as cerebral palsy, autism spectrum disorder, and genetic disorders. Children with developmental delay frequently experience impairments in motor skills, balance, and gait, which negatively a ffect their functional independence and social participation. Addressing these motor deficits is essential to enhance their quality of life.
Mindful movement and game-based training are two therapeutic approaches that have shown potential in improving motor performance in this population. Mindful movement emphasizes slow, controlled movements, body awareness, emotional regulation, imaginative play, and biomechanical warm-up exercises to enhance motor control. In contrast, game-based training employs engaging and interactive activities to improve motor coordination, balance, strength, and social interaction.
This randomized clinical trial aims to compare the effects of mindful movement and game-based training in children with developmental delay. The study will be conducted at Acme Hospital over a 10-month period and will include 36 children aged 9-11 years selected through non-probability convenient sampling. Participants will be assigned into two groups: Group A will receive mindful movement therapy, and Group B will undergo game-based training. Outcomes will be assessed using validated tools, including the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Pediatric Berg Balance Scale (PBS), Functional Reach Test (FRT), Observational Gait Scale (OGS), and Edinburgh Visual Gait Score (EVGS), to evaluate motor skills, balance, gait, and overall motor proficiency.
Detailed description
Developmental delay in children is characterized by a delay in cognitive, motor, language, and social skills development. It can be associated with conditions like cerebral palsy, autism spectrum disorder (ASD), and genetic disorders. Children with developmental delay often struggle with motor skills, balance, and gait, which can impair their ability to perform everyday tasks and engage socially. Addressing these issues is essential for improving their quality of life. Mindful movement and game-based training are two promising therapeutic interventions. Mindful movement, including practices like imaginative and reflective play, biomechanical warm ups improves motor skills by focusing on slow, deliberate movements, body awareness, and emotional regulation. Game-based training, on the other hand, uses engaging and interactive activities to enhance motor coordination, balance, and strength, while also fostering social interaction and cognitive development. This study is a randomized clinical trial to assess the effects of two interventions-mindful movement and game-based training-on children with developmental delay. It will be conducted at Acme Hospital, over a 10 month period. The study will involve 36 children aged 9-11 years, diagnosed with developmental delay, and will employ non-probability convenient sampling. The participants will be divided into two groups: Group A will receive mindful movement therapy, while Group B will undergo game-based training. Data will be collected using several assessment tools, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): 31-40 (22).Pediatric Berg Balance Scale (PBS) score of less than 45 (23). Functional Reach Test (FRT): 6-7 inches (22). Observational Gait Scale (OGS): >10 (22). Edinburgh Visual Gait Score (EVGS): <37. all of which have demonstrated strong reliability and validity. These tools will evaluate motor skills, balance, gait, and overall motor proficiency in the children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Mindful Movement Intervention | Experimental | Behavioral: Mindful movementParticipants in Arm A will receive a mindful movement program aimed at improving motor skills, balance, coordination, and emotional regulation. |
| Arm B: Game-Based Training Intervention | Experimental | Behavioral: Game based trainingParticipants in Arm B will receive a game-based training program designed to improve motor skills, balance, gait, strength, and overall fitness through engaging and age-appropriate games . |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children age 9-11 years
- Both male and female
- Children diagnosed with developmental delay by Pediatric neurologist
- Mini mental state examination >24
- Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): 31-40
Key exclusion criteria (6 listed)
- Any cognitive impairment that limits understanding of instructions
- Uncontrolled seizures or medical conditions that contraindicate therapy
- Participation in other structured physiotherapy programs targeting motor skills, gait and balance
- Children with severe visual or hearing impairments affecting the ability to follow intervention activities .
- Children with recent lower-limb orthopedic injuries, fractures, or surgeries within the previous 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 |
|---|---|---|
| Mindful movementThe intervention includes biomechanical warm-up exercises, imaginative play, animal-based movements, and reflective activities to enhance body awareness, posture, focus, and relaxation. Emphasis is placed on slow, controlled movements to promote mindfulness and overall physical and mental well-being. Each session will last 30-45 minutes, conducted two times per week, total 12 weeks. Components include: Biomechanical warm-ups: Gentle joint mobility exercises such as shoulder circles and slow marching (5-10 minutes). Imaginative play: Creative movement activities (e.g., tree pose with storytelling, emotion walks, butterfly hands) , Animal walks(bear walk, cat walk) to improve strength, coordination, and balance (approximately 30 minutes). Reflection and cool down: Mirror movements (walk) and "balloon hands" using slow, controlled hand movements to promote relaxation and control breathing.(5 minutes) | Behavioural | Arm A: Mindful Movement Intervention |
| Game based trainingThe intervention emphasizes active participation, enjoyment, and cognitive engagement. Each session will last 30-45 minutes, conducted two times per week, total 12 weeks. Components include: Warm-up: Walking activities to increase body temperature (5-10 minutes). Main practice: Game-based aerobic, strength, balance, and coordination activities such as The Sea, The Astronauts, Give Your Ball, and The Game of Colors (approximately 30 minutes). Cool-down: Deep breathing exercises to promote relaxation and reduce heart rate (5 minutes). | Behavioural | Arm B: Game-Based Training Intervention |
Primary outcome
Motor Skill Performance
Time frame: Baseline and 12 weeks
Tool: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Outcome: Change in BOT-2 total motor composite score The BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition) scoring converts raw scores into precise motor proficiency metrics for ages 4-21, using sex-specific norms.
Balance Ability
Time frame: Baseline and 12 weeks
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
Gait Quality
Time frame: Baseline and 12 weeks
Tools: Observational Gait Scale (OGS); The Observational Gait Scale (OGS) is a validated tool used to assess gait quality, particularly in children with cerebral palsy, by scoring key kinematic parameters from video or direct observation. It rates 8 specific gait components in the sagittal plane-including knee position, foot contact, and heel rise-resulting in a maximum score of 22 per limb. Lower scores indicate greater impairments
Edinburgh Gait Scale
Time frame: Baseline and 12 weeks
The Edinburgh Visual Gait Score (EVGS) is a comprehensive, video-based observational tool used to assess gait abnormalities, primarily in children with cerebral palsy (CP). It evaluates 17 parameters per limb across sagittal and coronal planes-focusing on the foot, knee, hip, pelvis, and trunk-using a 3-point ordinal scale (0=normal, 1=mild/moderate, 2=severe).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
Nimra Javed 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 Mindful movement and Game based training in people with Developmental Delay (Disorder), 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 9 inclusion and 6 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 28 Sep 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?
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?
Motor Skill Performance (time frame: Baseline and 12 weeks). The study lists 4 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 28 Sep 2026.