Autism Spectrum DisordersNCT02493699
Martial Arts Therapy in Autism Spectrum Disorders
A study testing physical exercise- based intervention (Karate techniques training) in people with Autism Spectrum Disorders, run by University of Isfahan.
Trial summary
The purpose of the present study was to determine whether teaching Karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- physical exercise- based intervention (Karate techniques training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Individuals diagnosed as autism spectrum disorders according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition, Text Revision.
- Age range in 5 to 16.
Who cannot join
- Not participating in up to 3 intervention sessions.
About this study
Official title: The Effect of Karate Techniques Training on Communication Deficit of Children With Autism Spectrum Disorders
The purpose of the present study was to determine whether teaching Karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders.
- Conditions
- Autism Spectrum Disorders
- Being tested
- physical exercise- based intervention (Karate techniques training)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercise- based intervention (Karate techniques training)Other
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | physical exercise- based intervention (Karate techniques training) Receives: Other: physical exercise- based intervention (Karate techniques training) |
| Control | No intervention | Not participating in physical exercise- based intervention (Karate techniques training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw score of communication subscale of Gilliam Autism Rating Scale-Second Edition (GARS-2) as the measure of communication deficit
Measured: within the first 30 days after termination of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Isfahan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatimah Bahrami, University of Isfahan
- Investigators
- Fatimah Bahrami, MS, Principal investigator, University of Isfahan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493699
- Sponsor's protocol ID
- 14/02/2011
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Karate Techniques Training on Communication Deficit of Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02493699
- Acronym / sponsor ID
- 14/02/2011
- Conditions
- Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of IsfahanUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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 purpose of the present study was to determine whether teaching Karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: physical exercise- based intervention (Karate techniques training)physical exercise- based intervention (Karate techniques training) |
| Control | No intervention | –Not participating in physical exercise- based intervention (Karate techniques training) |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Individuals diagnosed as autism spectrum disorders according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition, Text Revision.
- Age range in 5 to 16.
Key exclusion criteria (1 listed)
- Not participating in up to 3 intervention sessions.
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 |
|---|---|---|
| physical exercise- based intervention (Karate techniques training) | Other | Exercise |
Primary outcome
Raw score of communication subscale of Gilliam Autism Rating Scale-Second Edition (GARS-2) as the measure of communication deficit
Time frame: within the first 30 days after termination of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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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. This study is not recruiting at the moment.
Fatimah Bahrami, MS principal investigator
University of Isfahan
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise- based intervention (Karate techniques training) in people with Autism Spectrum Disorders, run by University of Isfahan.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raw score of communication subscale of Gilliam Autism Rating Scale-Second Edition (GARS-2) as the measure of communication deficit (time frame: within the first 30 days after termination of intervention). 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 9 Jul 2015.