Autism Spectrum DisorderNCT06277778
Effect of Combined Music and Taekwondo Training for Children with Autism Spectrum Disorder
A study testing Taekwondo training with music therapy and Taekwondo training alone in people with Autism Spectrum Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Taekwondo training with music therapy and Taekwondo training alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jun 2024to 31 Dec 2026
- 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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chinese children aged 7 to 9 years who have been clinically diagnosed as ASD by developmental paediatricians or clinical psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ASD.
Who cannot join
- children who have experience in Taekwondo training;
- children who have received music therapy within the previous 12 months;
- those who have severe sensory disorders (blindness or deafness);
- those who have underlying congenital abnormalities or other diseases that limit their ability to engage in physical activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kam-Ming Mok, PhD contact
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Polytechnic University
Hong Kong, 852
Clare CW Yu, Ph.D, +852 34003251, clare-chung-wah.yu@polyu.edu.hk
About this study
Official title: Effect of Combined Music and Taekwondo Training on the Psychological and Physical Condition of Children with Autism Spectrum Disorder: a Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Taekwondo training with music therapy, Taekwondo training alone
- Keywords
- music, taekwondo, Autism Spectrum Disorder
- 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.
Taekwondo training with music therapyOther
Taekwondo training with music therapy
Taekwondo training aloneOther
Taekwondo training without music therapy
| Study group | Role | What they receive |
|---|---|---|
| Taekwondo training with music therapy | Experimental | the participating children will attend 20 sessions of Taekwondo training with the presence of music. Receives: Other: Taekwondo training with music therapy |
| Taekwondo training alone | Sham comparator | the participating children will attend 20 sessions of Taekwondo training alone. Receives: Other: Taekwondo training alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in the Training Sessions
the Revised Individual Child Engagement Record (ICER); The ICER-R uses a 15-second momentary time sampling approach and involves the coding of types of engagement, the occurrence of interaction and the interaction partner (coach or peers), and whether the child was physically prompted. The types of engagement being coded at each 15-second interval are active engagement, passive engagement, active non-engagement, and passive non-engagement.
Measured: Through training completion, an average of 20 sessions over 10 consecutive weeks
Gross Motor Skills
Motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency-2
Measured: Baseline, 10 weeks
Secondary outcomes (10)
Physical Activity Level
Participants will wear an optical heart rate monitor on their forearm to measure their exercise heart rate as a reflection of the physical activity level during the training. Continuous heart rate data will be recorded for every record and expressed as the mean heart rate per min.
Measured: Through training completion, an average of 20 sessions over 10 consecutive weeks
Enjoyment State
The Children's Emotional Manifestation Scale (CEMS) will be used to assess the children's emotional state. It classifies observable emotional behaviours into five categories: 'Facial expression', 'Vocalization', 'Activity', 'Interaction', and 'Level of cooperation'. Each category is scored from 1 to 5. The numbers obtained for each category are added together to obtain the total score, which will be between 5 and 25. High scores indicate the manifestation of more negative emotional behavior.
Measured: Through training completion, an average of 20 sessions over 10 consecutive weeks
Rate of Perceived Exertion
Children will be asked to rate their exertion level using the Borg 6-to-20 Scale, in which "6" indicates "no exertion at all" and "20" indicates "maximal exertion".
Measured: Through training completion, an average of 20 sessions over 10 consecutive weeks
Taekwondo skills performance
A scoring system was modified for use in this project with reference to the international Taekwondo referee scoring standard. Children's performance for a set of selected Taekwondo moves and kicks will be observed and scored by two qualified referees. The performance will be scored out of 8 marks, with 3 marks for presentation, 2 marks for cognitive ability, 2 marks for basic skills, and 1 mark for social interaction. Higher scores indicate better performance.
Measured: Baseline, 10 weeks
Conners' Continuous Performance Test II
This test will be used to measure the children's selective attention, that is, their ability to maintain a consistent focus on some continuous stimuli.
Measured: Baseline, 10 weeks
Comprehensive Trail-Making Test (CTMT)
The test consists of five visual search and sequencing tasks that are heavily influenced by attention, concentration, resistance to distraction, and cognitive flexibility (or set-shifting). The child is required to connect a series of stimuli (numbers, expressed as numerals or in word form, and letters) in a specified order as fast as possible in each trial. The time scores for the five CTMT trials will be converted to standardized T-scores according to the reference tables in the testing manual, and be summed up to produce a global performance level score, the CTMT Composite Index (CI), which can then be converted into a percentile score according to the participant's chronological age. Higher T score and CTMT CI correspond to better performance.
Measured: Baseline, 10 weeks
Social Responsiveness Scale, second edition (SRS-2)
This scale will be completed by the parents. It is a 65-item autism rating scale widely use to identify a spectrum of deficits in reciprocal social behavior, ranging from absent to severe, based on observations of a child's behavior in various social settings. Scoring is on a four-point Likert Scale with five subscales (social awareness, social cognition, social communication, social motivation, and autistic mannerism). Higher T-scores correspond to poorer social functioning.
Measured: Baseline, 10 weeks
Childhood Autism Spectrum Test
This is a 39-item, yes-or-no questionnaire of children's social behavior and communication tendencies as reported by their parents. The questionnaire has been translated into Chinese and is being validated. The cut-off score of 15 marks indicates possible autism spectrum disorder (ASD) or related social-communication difficulties.
Measured: Baseline, 10 weeks
Strength and Difficulties Questionnaires (SDQ)
The questionnaire will be completed by parents. There are 25 items in the SDQ, which consists of five scales, each with five items, for assessing children's mental health status in terms of emotional, conduct, hyperactivity, peer problems, and prosocial behavior.
Measured: Baseline, 10 weeks
Clinical Global Improvement (CGI) score
The CGI-I will be completed by parents to evaluate children's functional changes in daily life after completion of the 10-week program, and at 2-month follow-up. The CGI-I consisted of 12 questions developed by our research team, which are focused on all core symptoms of ASD and covered the following aspects: (1) motor functioning; (2) children's capability to follow instructions; (3) social, communication, and language understanding and expression; and (4) children's capabilities for attention shifting, attention to complete a task, attention to details, and imagination.
Measured: 10 weeks, 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start30 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clare CW YU, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277778
- Sponsor's protocol ID
- HSEARS20211117003-03
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu CCW, Mok KM, Mak E, Au CT, Chan DFY, Wu S, Chung RCK, Ip MCK, Wong SWL. Protocol for evaluating the effects of integrating music with taekwondo training in children with autism spectrum disorder: A randomized controlled trial. PLoS One. 2025 Jan 31;20(1):e0315503. doi: 10.1371/journal.pone.0315503. eCollection 2025.
PubMed 39888930
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Music and Taekwondo Training on the Psychological and Physical Condition of Children with Autism Spectrum Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06277778
- Acronym / sponsor ID
- HSEARS20211117003-03
- Conditions
- Autism Spectrum Disorder
- Keywords
- music, taekwondo, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Feb 2024 (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 randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taekwondo training with music therapy | Experimental | Other: Taekwondo training with music therapythe participating children will attend 20 sessions of Taekwondo training with the presence of music. |
| Taekwondo training alone | Sham comparator | Other: Taekwondo training alonethe participating children will attend 20 sessions of Taekwondo training alone. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Chinese children aged 7 to 9 years who have been clinically diagnosed as ASD by developmental paediatricians or clinical psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ASD.
Key exclusion criteria (4 listed)
- children who have experience in Taekwondo training;
- children who have received music therapy within the previous 12 months;
- those who have severe sensory disorders (blindness or deafness);
- those who have underlying congenital abnormalities or other diseases that limit their ability to engage in physical activities.
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 |
|---|---|---|
| Taekwondo training with music therapyTaekwondo training with music therapy | Other | Taekwondo training with music therapy |
| Taekwondo training aloneTaekwondo training without music therapy | Other | Taekwondo training alone |
Primary outcome
Engagement in the Training Sessions
Time frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
the Revised Individual Child Engagement Record (ICER); The ICER-R uses a 15-second momentary time sampling approach and involves the coding of types of engagement, the occurrence of interaction and the interaction partner (coach or peers), and whether the child was physically prompted. The types of engagement being coded at each 15-second interval are active engagement, passive engagement, active non-engagement, and passive non-engagement.
Gross Motor Skills
Time frame: Baseline, 10 weeks
Motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency-2
10 secondary outcomes
Physical Activity Level
Time frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
Enjoyment State
Time frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
Rate of Perceived Exertion
Time frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
Taekwondo skills performance
Time frame: Baseline, 10 weeks
Conners' Continuous Performance Test II
Time frame: Baseline, 10 weeks
Comprehensive Trail-Making Test (CTMT)
Time frame: Baseline, 10 weeks
Social Responsiveness Scale, second edition (SRS-2)
Time frame: Baseline, 10 weeks
Childhood Autism Spectrum Test
Time frame: Baseline, 10 weeks
Strength and Difficulties Questionnaires (SDQ)
Time frame: Baseline, 10 weeks
Clinical Global Improvement (CGI) score
Time frame: 10 weeks, 2 months follow-up
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 13 Mar 2025.
- Derived from this study: PubMed 39888930Yu CCW, Mok KM, Mak E, Au CT, Chan DFY, Wu S, Chung RCK, Ip MCK, Wong SWL. Protocol for evaluating the effects of integrating music with taekwondo training in children with autism spectrum disorder: A randomized controlled trial. PLoS One. 2025 Jan 31;20(1):e0315503. doi: 10.1371/journal.pone.0315503. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Kam-Ming Mok, PhD contact
Clare CW YU, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taekwondo training with music therapy and Taekwondo training alone in people with Autism Spectrum Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 Clare CW YU, PhD (+85234003251, clare-chung-wah.yu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in the Training Sessions (time frame: Through training completion, an average of 20 sessions over 10 consecutive weeks). 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?
On the ClinicalTrials.gov record for NCT06277778, which also lists 1 linked publication.
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 13 Mar 2025.