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Not yet recruiting NCT07430436

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

No phase Interventional Attention Deficit Hyperactivity Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adapted karate training.
Who it may be relevant to
Registry conditions: Attention Deficit Hyperactivity Disorder. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving Self-regulation, Social Participation, and Functional Performance in Individuals With ADHD Through Adapted Karate Training: A Randomized Controlled Crossover Trial

Overview

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.

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

  • Canadian Occupational Performance Measure (COPM) [Time frame: 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 [Time frame: completing 15 sessions over eight weeks.]
Secondary outcome measures (11)
  • Dual Tasking gait analysis [Time frame: 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) [Time frame: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
  • The Birthday Task Assessment [Time frame: 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) [Time frame: 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) [Time frame: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
  • Short Sensory Profile (SSP 2) [Time frame: 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) [Time frame: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
  • Participation In Childhood Occupation (PICO) [Time frame: 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 [Time frame: 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) [Time frame: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).]
  • In-depth semi-structured interview [Time frame: T3 (8 weeks post T2(8 weeks from baseline)).]

Eligibility criteria

Inclusion criteria

  • Diagnosed by a developmental neurologist with ADHD
  • Age 6-12 years
  • Fluent in Hebrew

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Israel · 1 center
  • Tel Aviv University — Tel Aviv

Identifiers

NCT: NCT07430436 · 0005796-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗