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

17 de julho de 2026 atualizado por: 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 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.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

36

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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

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 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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 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)

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 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Motor Skill Performance
Prazo: 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.
Baseline and 12 weeks
Balance Ability
Prazo: Baseline and 12 weeks
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
Baseline and 12 weeks
Gait Quality
Prazo: 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
Baseline and 12 weeks
Edinburgh Gait Scale
Prazo: 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).
Baseline and 12 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Nimra Javed, Riphah International University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

30 de setembro de 2026

Conclusão do estudo (Estimado)

30 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2026

Primeira postagem (Real)

8 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • RCR & AHS/25/0709/Nimra Javed

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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