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Набор скоро начнётся NCT07575165

Mindful Movement And GAME BASED Training In Developmental Delay

Без фазы С лечением Developmental Delay (Disorder)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mindful movement, Game based training.
Кому может быть актуально
Состояния в реестре: Developmental Delay (Disorder). Базовые параметры: 9 лет — 11 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparative Effects Of Mindful Movement And Game Based Training On Motor Skills, Balance And Gait In Children With Developmental Delay

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Mindful movement
    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 ma
  • Поведенческое Game based training
    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 rel

Первичные конечные точки

  • Motor Skill Performance [Срок оценки: Baseline and 12 weeks]
  • Balance Ability [Срок оценки: Baseline and 12 weeks]
  • Gait Quality [Срок оценки: Baseline and 12 weeks]
  • Edinburgh Gait Scale [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Riphah Rehabilitation Center, Riphah International University — Lahore

Идентификаторы

NCT: NCT07575165 · RCR & AHS/25/0709/Nimra Javed

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗