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Not Yet RecruitingNCT07430436

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
55 (estimated)
Sponsor
Tel Aviv University · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERAdapted karate trainingParticipants 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.

Timeline

Start date
2026-02-26
Primary completion
2027-12-30
Completion
2027-12-30
First posted
2026-02-24
Last updated
2026-02-24

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT07430436. Inclusion in this directory is not an endorsement.