Effect of Combined Music and Taekwondo Training for Children with Autism Spectrum Disorder

March 11, 2025 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Taekwondo training with music therapy
the participating children will attend 20 sessions of Taekwondo training with the presence of music.
Other: Taekwondo training with music therapy
Taekwondo training with music therapy
Sham Comparator: Taekwondo training alone
the participating children will attend 20 sessions of Taekwondo training alone.
Other: Taekwondo training alone
Taekwondo training without music therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through training completion, an average of 20 sessions over 10 consecutive weeks
Gross Motor Skills
Time Frame: Baseline, 10 weeks
Motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency-2
Baseline, 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Activity Level
Time Frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
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.
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
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.
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
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".
Through training completion, an average of 20 sessions over 10 consecutive weeks
Taekwondo skills performance
Time Frame: Baseline, 10 weeks
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.
Baseline, 10 weeks
Conners' Continuous Performance Test II
Time Frame: Baseline, 10 weeks
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.
Baseline, 10 weeks
Comprehensive Trail-Making Test (CTMT)
Time Frame: Baseline, 10 weeks
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.
Baseline, 10 weeks
Social Responsiveness Scale, second edition (SRS-2)
Time Frame: Baseline, 10 weeks
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.
Baseline, 10 weeks
Childhood Autism Spectrum Test
Time Frame: Baseline, 10 weeks
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.
Baseline, 10 weeks
Strength and Difficulties Questionnaires (SDQ)
Time Frame: Baseline, 10 weeks
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.
Baseline, 10 weeks
Clinical Global Improvement (CGI) score
Time Frame: 10 weeks, 2 months follow-up
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.
10 weeks, 2 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clare CW YU, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20211117003-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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