- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575165
Mindful Movement And GAME BASED Training In Developmental Delay (MINDGAME)
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 affect 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 PSRD Hospital over a 10-month period and will include 36 children aged 9-11 years selected through non-probability convenience sampling. Participants will be randomly assigned to 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Khadija Liaquat, MS
- Phone Number: 051591289095
- Email: khadija.liaquat@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Riphah Rehabilitation Center, Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children age 9-11 years
- Both male and female
- Children diagnosed with developmental delay
- Mini mental state examination
- Participants who are able to understand and follow the instruction
- Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): < 25th percentile
- Pediatric Berg Balance Scale (PBS) score of less than 45
- Functional Reach Test (FRT): < 6-7 inches
- Observational Gait Scale (OGS): Likert-type scale 0 to 4
- Edinburgh Visual Gait Score (EVGS): Scale 0 to 6
Exclusion Criteria:
- 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 other neurological diseases will be excluded
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: Arm A: Mindful Movement Intervention
Participants in Arm A will receive a mindful movement program aimed at improving motor skills, balance, coordination, and emotional regulation.
|
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 45 minutes, conducted three times per week, total 12 sessions. 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, breathing with hand tracing) , Animal walks(bear crawl, crab walk, frog jumps) to improve strength, coordination, and balance (approximately 30 minutes). Reflection: Mirror movements and "balloon hands" using slow, controlled hand movements to promote relaxation and motor control (5 minutes). |
|
Experimental: Arm B: Game-Based Training Intervention
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.
|
The intervention emphasizes active participation, enjoyment, and cognitive engagement. Each session will last 45 minutes, conducted three times per week, total 12 sessions. 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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Skill Performance
Time Frame: Baseline and 4 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.
|
Baseline and 4 weeks
|
|
Balance Ability
Time Frame: Baseline and 4 weeks
|
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
|
Baseline and 4 weeks
|
|
Gait Quality
Time Frame: Baseline and 4 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
|
Baseline and 4 weeks
|
|
Edinburgh Gait Scale
Time Frame: Baseline and 4 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).
|
Baseline and 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khadija Liaquat, MS, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah IU Nimra
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.
Clinical Trials on Developmental Delay (Disorder)
-
Florida Gulf Coast UniversityYeshiva UniversityRecruiting
-
FH Campus Wien, University of Applied SciencesCompletedDevelopmental Delay in Fine Motor Function (Disorder)Austria
-
Indonesia UniversityCompletedChild Development | Developmental Delay | Development Delay | Child Development Disorder | Motor Delay | Global Developmental Delay | Speech DelayIndonesia
-
Indonesia UniversityCompletedCommunication Disorders | Child Development | Developmental Delay | Infant Development | Development Delay | Child Development Disorder | Motor Delay | Global Developmental Delay | Speech DelayIndonesia
-
Eunice Kennedy Shriver National Institute of Child...CompletedMental Retardation | Developmental Delay DisorderUnited States
-
Tokat Gaziosmanpasa UniversityRecruiting
-
Florida Gulf Coast UniversityRecruitingDevelopmental DelayUnited States
-
Taipei Medical UniversityNot yet recruiting
-
Hacettepe UniversityCompleted
-
Salus UniversityActive, not recruitingDevelopmental DelayUnited States
Clinical Trials on Mindful movement
-
The Miriam HospitalRhode Island FoundationNot yet recruitingEndometriosis | Pelvic Pain
-
Saint John's Cancer InstituteCompleted
-
Hugo W. Moser Research Institute at Kennedy Krieger...National Center for Advancing Translational Sciences (NCATS)CompletedMindful Movement Intervention (MMI)United States
-
Drexel UniversityCompletedPhysical Activity | Cognitive Decline | Psychological WellbeingUnited States
-
University of MinnesotaNational Center for Complementary and Integrative Health (NCCIH); YMCACompletedWellbeing | Mindfulness | Physical InactivtyUnited States
-
University at BuffaloCompleted
-
Wayne State UniversityCompleted
-
University of MinnesotaNational Center for Complementary and Integrative Health (NCCIH); YMCACompletedPhysical InactivityUnited States
-
University of SevilleActive, not recruitingPost COVID Syndrome | Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)Spain
-
University of Texas Southwestern Medical CenterCompletedDepression | Pain | Anxiety StateUnited States