Mindful Movement And GAME BASED Training In Developmental Delay

NCT07575165 | Not Yet Recruiting

• 1 other identifier: RCR & AHS/25/0709/Nimra Javed
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Developmental Delay (Disorder)

Keywords

Developmental Delay Mindful Movement Game-Based Training

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 12 weeks

• Balance Ability

  Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score

  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

  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).

  Baseline and 12 weeks

Study Arms (2)

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.

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 .

Behavioral: Game based training

Interventions

Mindful movement BEHAVIORAL

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, breathing with hand tracing) , Animal walks(bear walk, cat walk) to improve strength, coordination, and balance (approximately 30 minutes). Reflection and cool down: Mirror movements and "balloon hands" using slow, controlled hand movements to promote relaxation and motor control.(5 minutes)

Arm A: Mindful Movement Intervention

Game based training BEHAVIORAL

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).

Arm B: Game-Based Training Intervention

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 9-11 years
• Both male and female
• Children diagnosed with developmental delay
• Mini mental state examination \>24
• Participants who are able to understand and follow the instruction
• Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): \< 40
• Pediatric Berg Balance Scale (PBS) score of less than 45
• Functional Reach Test (FRT): 6-7 inches
• Observational Gait Scale (OGS): 0-3, \>10
• Edinburgh Visual Gait Score (EVGS): \< 37

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Center, Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nimra Javed

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Khadija Liaquat, MS-NMPT

CONTACT

03334956854; khadijaliaquat90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: May 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)