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

NCT07430436 | Not Yet Recruiting

• 1 other identifier: 0005796-4
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the AKT more effective than no karate training in enhancing functional performance, self-regulation and school QoL?
2. 2.Are poorer executive functions, emotional regulation, and sensory processing associated with higher gains?

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Self Regulation; Karate; Occupational Therapy; Participation

Outcome Measures

Primary Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure for individuals to identify and prioritize everyday issues that restrict their participation in everyday living. Participants will define three goals, and rate their current performance \& satisfaction for each goal using a 10-point scale. Higher scores indicate better outcomes.

  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

  Total number of participants completing the AKT, 15 sessions.

  completing 15 sessions over eight weeks.

Secondary Outcomes (11)

• Dual Tasking gait analysis

  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)

  Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).

• The Birthday Task Assessment

  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)

  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)

  Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).

Study Arms (2)

Adapted karate training

EXPERIMENTAL

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.

Other: Adapted karate training

No intervention

NO INTERVENTION

This group will receive no intervention.

Interventions

Adapted karate training OTHER

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.

Adapted karate training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead
• Assuta Ashdod Hospital: collaborator
• Ministry of Health, Israel: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, 6139001, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Self-Control

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Tami Bar-Shalita, Proffesor

  Tel Aviv University

  STUDY DIRECTOR

• Itai Berger, Professor

  Assuta Ashdod Hospital

  STUDY DIRECTOR

Central Study Contacts

Tami Bar-Shalita, Dr.

CONTACT

972-3-6405447; tbshalita@tauex.tau.ac.il

Yehudit Harris, MSc

CONTACT

972-52-5931777; harris.yehudit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessors in the RCT will be blind to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled crossover trial including two sequences: (1) The experimental group receiving AKT followed by a no-intervention period; (2) A control group receiving no intervention, followed by the AKT intervention.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 24, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data will be made available following publication and for 5 years following publication.
• Access Criteria: De-identified individual participant data will be shared with qualified academic and clinical researchers upon reasonable request through researchers email address, following approval of a proposal and execution of a data use agreement.

Locations

IL (1)