Mindful Movement And GAME BASED Training In Developmental Delay (MINDGAME)

May 4, 2026 updated by: Riphah International University

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

Not yet recruiting

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 PSRD 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 convenience 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): < 25th percentile (22).Pediatric Berg Balance Scale (PBS) score of less than 45 (23). Functional Reach Test (FRT): < 6-7 inches (22). Observational Gait Scale (OGS): Likert-type scale 0 to 4 (22). Edinburgh Visual Gait Score (EVGS): Scale 0 to 6 (23). 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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • 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 Contact

Study Locations

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Riphah Rehabilitation Center, Riphah International University

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

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: 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

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

Investigators

  • 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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 25, 2026

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Riphah IU Nimra

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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