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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06277778
Other study ID # HSEARS20211117003-03
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2026

Study information

Verified date January 2024
Source The Hong Kong Polytechnic University
Contact Clare CW YU, PhD
Phone +85234003251
Email clare-chung-wah.yu@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 7 Years to 9 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Taekwondo training with music therapy
Taekwondo training with music therapy
Taekwondo training alone
Taekwondo training without music therapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through training completion, an average of 20 sessions over 10 consecutive weeks
Primary Gross Motor Skills Motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency-2 Baseline, 10 weeks
Secondary 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. Through training completion, an average of 20 sessions over 10 consecutive weeks
Secondary 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. Through training completion, an average of 20 sessions over 10 consecutive weeks
Secondary 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". Through training completion, an average of 20 sessions over 10 consecutive weeks
Secondary 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. Baseline, 10 weeks
Secondary 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. Baseline, 10 weeks
Secondary 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. Baseline, 10 weeks
Secondary 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. Baseline, 10 weeks
Secondary 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. Baseline, 10 weeks
Secondary 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. Baseline, 10 weeks
Secondary 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. 10 weeks, 2 months follow-up
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