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Набор скоро начнётся NCT07430436

Improving Self-regulation in Individuals With ADHD Through Adapted Karate Training

Без фазы С лечением Attention Deficit Hyperactivity 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: 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
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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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗