Mindful Movement And GAME BASED Training In Developmental Delay

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-11
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children age 9-11 years

Both male and female

Children diagnosed with developmental delay

Mini mental state examination

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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).

  • Game based training

    Behavioral

    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).

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Arm A: Mindful Movement InterventionExperimental treatment 1 intervention
Group B: Arm B: Game-Based Training InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 4 weeks
2

Balance Ability

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

Time frame
Baseline and 4 weeks
3

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

Time frame
Baseline and 4 weeks
4

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).

Time frame
Baseline and 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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