Attention Deficit Hyperactivity DisorderNCT07430436
Improving Self-regulation in Individuals With ADHD Through Adapted Karate Training
A study testing Adapted karate training in people with Attention Deficit Hyperactivity Disorder, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Adapted karate training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Feb 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed by a developmental neurologist with ADHD
- Age 6-12 years
- Fluent in Hebrew
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Self-regulation, Social Participation, and Functional Performance in Individuals With ADHD Through Adapted Karate Training: A Randomized Controlled Crossover Trial
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:
Read more
- Is the AKT more effective than no karate training in enhancing functional performance, self-regulation and school QoL?
- 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.
Read the 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
- Attention Deficit Hyperactivity Disorder
- Being tested
- Adapted karate training
- Keywords
- Attention Deficit Hyperactivity Disorder, Self Regulation, Karate, Occupational Therapy, Participation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted karate trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Adapted karate training |
| No intervention | No intervention | This group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: completing 15 sessions over eight weeks.
Secondary outcomes (11)
Dual Tasking gait analysis
gait analysis (stride and pace) of a one minute walk: first walking only, then walking while doing a cognitive task (following digits via audio and recognizing repeated items).
Measured: 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)
A standardized assessment battery that examines executive function in children and adolescents aged 8-16 years. The BADS-C consists of six subtests (adapted and simplified from the BADS) that assess inflexibility, perseverance, novel problem solving, impulsivity, planning, and the ability to utilize feedback in order to moderate behavior. We will use the Zoo map subtest. Raw scores for each of the component subtests can be converted to age-scaled scores, which are adjusted for the child's age and estimated IQ. Age-scaled scores range from 1 to 19, with a mean of 10 and a standard deviation of 3.
Measured: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).
The Birthday Task Assessment
The Birthday Task Assessment is a performance-based tool assessing executive functions in children aged 8-16, through a simulated daily activity. It includes three progressively complex tasks: wrapping gifts, writing a card, and making sandwiches. Performance is evaluated by sequencing, timing, and rule adherence, with higher error rates indicating greater executive difficulties.
Measured: 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)
The The Preschool Executive Task Assessment (PETA) is a performance-based measure assessing executive functioning in young children aged 3-8, through completion of a structured, multi-step task involving assembling a caterpillar picture. Performance is scored based on task completion time and a standardized hierarchy of cues ranging from independent performance to full physical assistance, with higher scores indicating greater reliance on external.
Measured: 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)
An 86-item questionnaire assessing executive function in everyday environments. The BRIEF is composed of eight clinical scales, which together produce an overall Global Executive Composite (GEC). Based on the past 30 days, items are graded on a 3-point scale: 'never' (1), 'sometimes' (2), or 'always' (3). The raw scores are converted to T-scores which are used to interpret the child's level of executive functioning as reported by parents and/or teachers on the BRIEF rating forms. These scores are linear transformations of the raw scale scores (M = 50, SD = 10).
Measured: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).
Short Sensory Profile (SSP 2)
A 34-item parent screening questionnaire designed to measure behaviors associated with abnormal responses to sensory stimuli in children aged 3.0-14.11 years. Response scale aimed at the frequency the child displays each scenario (item), and scored on a Likert scale ranging from 1 (almost never = 10% or less) to 5 (almost always = 90% or more). Scores are compiled into a "sensory-processing" domain that directly links with sensory modulation (14 item scale); and a "sensory-behavior" domain that links to behavioral concerns reflective of sensory modulation difficulties (20 item scales). For the sensory processing scale, 32-40 indicates "more than others", 41-70 indicates "much more than others". For behavioral scale, 47-59 indicates "more than others", 60-100 indicates "much more than others".
Measured: 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)
The DERS-P is a 36-item parent report, aimed to assess parental perceptions of adolescent Emotional Dysregulation, measuring six facets of emotion regulation: Awareness (6 items), Clarity (5 items), Goals (5 items), Impulse (6 items), Nonacceptance (6 items), and Strategies (8 items). Items are rated on a scale of 1 ("almost never" 0-10%) to 5 ("almost always" 91-100%). Higher scores indicate greater ED.
Measured: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).
Participation In Childhood Occupation (PICO)
A 30-item instrument which measures the difficulty level, enjoyment, and frequency of performance for children's participation in daily occupations in a variety of environments throughout the day. The parent assesses each activity in all three parameters, with answers ranging from 1 (no difficulty) to 5 (much difficulty).
Measured: 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
A 36 item questionnaire for elementary school students, which includes statements regarding situations and experiences of a student throughout the school day. The child rates these sentences as true to his experience or not, on a scale of 1-4 (1- never true, 4- always true).
Measured: 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)
The PQ is a parent questionnaire that assesses the extent of a child's engagement in PAs and in sedentary recreational activities. The PQ-Modified, used in this study, includes two of the 12 items from the PQ: (a) the average number of weekly hours that the child engages in various PAs (structured as well as unstructured activities) and (b) the child's PA level compared to his or her peers, rated on a Likert scale (1 ¼ very inactive, 5 ¼ very active).
Measured: Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2).
In-depth semi-structured interview
A semi-structured interview, comprising of 2 open-end questions aiming to understand how parents of children with ADHD perceive the contribution of the intervention process to their child. The interview will comprise questions such as What did the intervention program contribute to your child?
Measured: T3 (8 weeks post T2(8 weeks from baseline)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start26 Feb 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Assuta Ashdod Hospital, Ministry of Health, Israel
- Responsible party
- Principal investigator, Tami Bar-Shalita, Tel Aviv University
- Investigators
- Tami Bar-Shalita, Proffesor, Study director, Tel Aviv UniversityItai Berger, Professor, Study director, Assuta Ashdod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430436
- Sponsor's protocol ID
- 0005796-4
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected throughout the trial will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-regulation, Social Participation, and Functional Performance in Individuals With ADHD Through Adapted Karate Training: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT07430436
- Acronym / sponsor ID
- 0005796-4
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Self Regulation, Karate, Occupational Therapy, Participation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Assuta Ashdod Hospital, Ministry of Health, Israel
- Study start
- 26 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the AKT more effective than no karate training in enhancing functional performance, self-regulation and school QoL?
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adapted karate training | Experimental | Other: Adapted 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. |
| No intervention | No intervention | –This group will receive no intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed by a developmental neurologist with ADHD
- Age 6-12 years
- Fluent in Hebrew
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted 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. | Other | Adapted karate training |
Primary outcome
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).
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.
Total number of participants completing the intervention
Time frame: completing 15 sessions over eight weeks.
Total number of participants completing the AKT, 15 sessions.
11 secondary outcomes
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)).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected throughout the trial will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tami Bar-Shalita, Proffesor study director
Tel Aviv University
Itai Berger, Professor study director
Assuta Ashdod Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted karate training in people with Attention Deficit Hyperactivity Disorder, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tami Bar-Shalita, Dr. (972-3-6405447, tbshalita@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.