Comparative Effects Of Mindful Movement And Game Based Training On Motor Skills, Balance And Gait In Children With Developmental Delay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Motor Skill Performance
研究概览
简要总结
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.
详细描述
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): <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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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 .
干预措施: Game based training (Behavioral)
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.
干预措施: Mindful movement (Behavioral)
结局指标
主要结局
Motor Skill Performance
时间窗: 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
时间窗: Baseline and 12 weeks
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
Gait Quality
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点