Improving Self-regulation in Individuals With ADHD Through Adapted Karate Training
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: Adapted karate training.
- Кому может быть актуально
- Состояния в реестре: Attention Deficit Hyperactivity Disorder. Базовые параметры: 6 лет — 12 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
- Израиль
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Improving Self-regulation, Social Participation, and Functional Performance in Individuals With ADHD Through Adapted Karate Training: A Randomized Controlled Crossover Trial
Обзор
The goal of this clinical trial is to examine the effectiveness of Adaptive Karate Training (AKT) in improving self-regulation and daily function in children with ADHD, exploring the underlying mechanisms. The main questions it aims to answer are: 1. Is the AKT more effective than no karate training in enhancing functional performance, self-regulation and school QoL? 2. Are poorer executive functions, emotional regulation, and sensory processing associated with higher gains? Researchers will compare two sequences: (1) A group receiving AKT followed by a no-intervention period; (2) A group receiving no intervention, followed by the AKT intervention, to see if differences are observed between intervention and no-intervention periods, both between groups and within participants over time. Participants will engage in AKT sessions twice a week, each session lasting 60 minutes, over a period of two months.
Подробное описание
Methods: Following baseline assessment (T1), participants will be randomly allocated to one of the two sequences. After an eight-week period, all participants will complete a second assessment (T2). The groups will then switch conditions: children who initially received the AKT will receive no intervention, while those in the control group will receive the AKT. A third assessment (T3) will be conducted for all participants eight weeks post T2. All assessments will be administered by an assessor blinded to group allocation.
Participants: Sample size calculation was performed with G\*Power 3.1.9.7 to detect between group differences (F test, ANOVA: Repeated measures, within-between interaction) with a medium effect size (f=0.2), significance level=0.05 and power=0.8. The total sample size needed is 50, and considering \~ 10% dropout, a total of 55 children, ages 6-12 will be recruited.
Intervention: Adapted Karate Training (AKT) is a structured, group-based intervention derived from traditional karate practice and modified to accommodate the attentional, sensory, emotional, and self-regulatory characteristics of children with ADHD. The protocol emphasizes continuity of participation, positive experiences, and the development of individualized self-regulation strategies through adapted movement sequences, structured routines, and supportive instructional method. All participants in the study will engage in AKT sessions twice weekly, each session lasting 60 minutes, over a period of two months.
Data Analysis: Descriptive statistics will be used to describe the participants in terms of their demographic information, primary and secondary outcome measures. Data will be analyzed using repeated-measures models appropriate for a randomized controlled crossover design, examining within-subject changes over time and between-condition effects, while accounting for intervention order. Effect sizes will be reported. Statistical significance will be set at p \< 0.05.
Вмешательства
- Другое Adapted karate training
Participants will undergo adapted karate training practices, 2 hours weekly for two months, with a karate instructor and an Occupational Therapist specializing in neurodevelopmental disorders, including ADHD.
Первичные конечные точки
- Canadian Occupational Performance Measure (COPM) [Срок оценки: changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Total number of participants completing the intervention [Срок оценки: completing 15 sessions over eight weeks.]
Вторичные конечные точки (11)
- Dual Tasking gait analysis [Срок оценки: changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Behavioral Assessment of the Dysexecutive Syndrome for Children (BADS-zoo map) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- The Birthday Task Assessment [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- The The Preschool Executive Task Assessment (PETA) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Behavior Rating Inventory of Executive function (BRIEF) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Short Sensory Profile (SSP 2) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Difficulties in Emotion Regulation Scale- Parent Report (DERS-P) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Participation In Childhood Occupation (PICO) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Quality of life in school (QoLS) questionnaire [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- Participation in Physical Activity and Sedentary Behavior Questionnaire (PQ) [Срок оценки: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
- In-depth semi-structured interview [Срок оценки: T3 (8 weeks post T2(8 weeks from baseline)).]
Критерии участия
Критерии включения
- Diagnosed by a developmental neurologist with ADHD
- Age 6-12 years
- Fluent in Hebrew
Критерии исключения
- Comorbidity with another psychiatric or neurological diagnosis, or a developmental syndrome
- Chronic pain
- enrolled in a special education system
- substance abuse (i.e., reporting more than 10 cups of alcohol a week)
- currently participating in other non-pharmaceutical therapies (e.g., cognitive therapies) started during the past 6 months.
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
- Организация здравоохранения
Центры проведения
Израиль · 1 центр
- Tel Aviv University — Tel Aviv
Идентификаторы
NCT: NCT07430436 · 0005796-4