Protocol summary

Study aim
The aim of this study is to investigate the effect of a 12-week karate and basketball training program on social skills and physical fitness in preschool children with autism spectrum disorder (ASD).
Design
Three-arm randomized controlled trial (karate, basketball, control) with pre- and post-intervention assessments.
Settings and conduct
This study was conducted as a clinical trial across three specialized autism treatment centers in Tehran, involving 51 children aged 3–6 years diagnosed with autism spectrum disorder. Participants were randomly and evenly assigned to three groups: karate, basketball, and control. The karate and basketball groups underwent 12 weeks of training, with three 60-minute sessions per week. Social skills and physical fitness were assessed before and after the intervention. No blinding was applied.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of Autism Spectrum Disorder (ASD) based on DSM-IV-TR criteria, Age between 3 to 6 years, No prior participation in formal karate or basketball training, Medically cleared for physical activity participation, Parental consent for participation Exclusion Criteria: Presence of severe psychiatric or neurological disorders, Severe visual or auditory impairments preventing participation in exercise, Medical conditions restricting physical activity, Use of medications affecting motor or cognitive function, Severe behavioral issues preventing cooperation in training sessions
Intervention groups
The karate, basketball, and control groups. The karate and basketball groups performed 12 weeks of specific exercise training (three 60-minute sessions per week), while the control group did not participate in any physical activity.
Main outcome variables
Social Responsiveness Scale (SRS-2); balance; cardiorespiratory endurance; speed; handgrip strength; long jump.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241205063953N3
Registration date: 2025-03-25, 1404/01/05
Registration timing: prospective

Last update: 2025-03-25, 1404/01/05
Update count: 0
Registration date
2025-03-25, 1404/01/05
Registrant information
Name
akram jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 547 9267
Email address
jafari.akm@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-20, 1404/02/30
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Individual and Group Exercise Interventions on Social Skills and Physical Fitness in Children with Autism Spectrum Disorder
Public title
Effectiveness of Karate and Basketball Training on Social Skills and Physical Fitness in Children with Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Autism Spectrum Disorder (ASD) based on DSM-IV-TR criteria Age between 3 to 6 years No prior participation in formal karate or basketball training Physical ability to participate in exercises, confirmed by a physician Parental consent for the child's participation in the study
Exclusion criteria:
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization was used to assign participants to study groups. The randomization unit was individual, meaning that each child was independently assigned to one of the three groups: karate, basketball, or control. The randomization tool was EXECL software which generated the random sequence before the study began to prevent allocation bias. Allocation concealment was ensured using sealed and numbered opaque envelopes containing the group assignment for each participant. These envelopes were opened only after a participant's eligibility was confirmed by an independent researcher not involved in the randomization process. Stratified randomization was applied based on age and autism severity to ensure balance across groups for these key variables.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University Shahrekord Branch
Street address
Rahmatieh, Islamic Azad University Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881863003
Approval date
2024-06-05, 1403/03/16
Ethics committee reference number
IR.IAU.SHK.REC.1403.058

Health conditions studied

1

Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
social communication
Timepoint
48 hours before and after 12 weeks of research
Method of measurement
Social Responsiveness Scale Second Edition (SRS-2)

2

Description
Balance
Timepoint
48 hours before and after 12 weeks of research
Method of measurement
one leg balance test

3

Description
Cardiorespiratory Endurance
Timepoint
48 hours before and after 12 weeks of research
Method of measurement
10 × 20 m endurance test

4

Description
Sprint
Timepoint
48 hours before and after 12 weeks of research
Method of measurement
20 m sprint test

5

Description
handgrip strength
Timepoint
48 hours before and after 12 weeks of research
Method of measurement
hand grip dynamometer

6

Description
standing broad jump
Timepoint
48 hours before and after 12 weeks of research
Method of measurement
standing broad jump test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Karate group. This group practiced karate under the supervision of instructors for 12 weeks, 3 sessions per week, 60 minutes per session.
Category
Treatment - Other

2

Description
Intervention group: Basketball group. This group practiced basketball under the supervision of instructors for 12 weeks, 3 sessions per week, 60 minutes per session.
Category
Treatment - Other

3

Description
Control group: No sports activities were involved during the research.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Shahrekord Branch
Full name of responsible person
Farshid Khairi
Street address
Rahmatieh, Islamic Azad University Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818630003
Phone
+98 912 547 9267
Email
jafari.akm@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshid Khairi
Street address
Rahmatieh, Islamic Azad University Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818630003
Phone
+98 38 3336 1001
Email
jafari.akm@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
sport physiology
Street address
Rahmatieh, Islamic Azad University Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818630003
Phone
+98 38 3336 1001
Email
jafari.akm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
sport physiology
Street address
Rahmatieh, Islamic Azad University Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817630003
Phone
+98 38 3336 1001
Email
jafari.akm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Jafari
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
sport physiology
Street address
Rahmatieh, Islamic Azad University Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817630003
Phone
+98 38 3336 1001
Email
jafari.akm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data without participant names
When the data will become available and for how long
6 months after publication of the article
To whom data/document is available
University students and professors
Under which criteria data/document could be used
For future research
From where data/document is obtainable
To the researchers of this study
What processes are involved for a request to access data/document
By email to researchers
Comments
Loading...