NCT07322952

Brief Summary

This randomized controlled trial evaluates the effectiveness of a "Gamified Tai Chi" intervention on improving executive functions (such as inhibitory control, working memory, and cognitive flexibility) in children with Autism Spectrum Disorder (ASD). The study aims to determine whether integrating game mechanics (based on the Mechanics, Dynamics, and Aesthetics framework) into Tai Chi training offers superior benefits compared to traditional Tai Chi training or routine care. Approximately 200 children aged 8-15 years will be randomly assigned to one of three groups for a 12 months period: Gamified Tai Chi Group: Participants will attend sessions combining simplified Tai Chi forms with interactive tasks, such as digital chasing games and cooperative challenges, using a point-based reward system to enhance engagement. Traditional Tai Chi Group: Participants will learn the same Tai Chi movements but via standard instruction methods without gamification elements. Control Group: Participants will continue their routine rehabilitation or physical education classes (Waitlist design). Assessors who are blinded to group allocation will evaluate outcomes at baseline and post-intervention using standardized cognitive tasks (e.g., Flanker task, 1-back task) and behavioral questionnaires regarding social functioning and daily living skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

June 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

December 22, 2025

Last Update Submit

June 2, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in working memory measured by the 1-back task

    Working memory is assessed with a computerized 1-back task. Outcomes are mean accuracy and mean reaction time, together with d' as an index of perceptual sensitivity; the 1-back d' is the principal working-memory index. Higher accuracy and higher d' indicate better working-memory performance.

    Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

  • Change in inhibitory control measured by the Flanker task

    Inhibitory control is assessed with a child-adapted computerized Flanker task. Outcomes are mean accuracy and mean reaction time in each condition and the Flanker conflict effect (the incongruent-minus-congruent difference in reaction time or error rate). Higher accuracy and a smaller conflict effect indicate better inhibitory control.

    Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

  • Change in cognitive flexibility measured by the Dimensional Change Card Sort (DCCS) task

    Cognitive flexibility is assessed with a computerized Dimensional Change Card Sort (DCCS) task in which children first sort cards by color and then by shape after the rule changes. Outcomes are mean accuracy and mean reaction time and the switch cost (the change in performance after the rule switch). Higher accuracy and a smaller switch cost indicate better cognitive flexibility.

    Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

Secondary Outcomes (4)

  • Change in restricted and repetitive behaviors measured by the Repetitive Behavior Scale-Revised (RBS-R)

    Time Frame: Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

  • Change in aberrant behaviors measured by the Aberrant Behavior Checklist (ABC)

    Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

  • Change in emotion regulation difficulties measured by the Difficulties in Emotion Regulation Scale (DERS)

    Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

  • Change in overall strengths and difficulties measured by the Strengths and Difficulties Questionnaire (SDQ)

    Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)

Study Arms (3)

Control Group

NO INTERVENTION

Participants will maintain their routine rehabilitation courses and standard physical education classes as per the school curriculum. No additional Tai Chi training will be provided during the 12 months study period. They may be offered Tai Chi training after the study conclusion (Waitlist design).

Traditional Tai Chi Group

ACTIVE COMPARATOR

Participants in this arm receive regular curriculum activities for 16 weeks at the same frequency and duration as the intervention arm (3 sessions/week, 45 minutes/session; 48 sessions in total), delivered by regular teaching staff. These activities include basic physical activities, simple movement practice, classroom routines, and usual rehabilitation activities. This arm does not include Tai Chi, gamified movement tasks, or structured executive-function training. After the 16-week period, participants enter an 8-week natural follow-up during which they continue their usual school curriculum and daily routines.

Behavioral: Traditional Tai Chi Group

Gamified Tai Chi Group

EXPERIMENTAL

Participants will receive a 12 months Gamified Tai Chi intervention (3 sessions/week, 45 mins/session). The intervention integrates the MDA (Mechanics, Dynamics, Aesthetics) framework and exergaming elements into traditional Tai Chi movements to target executive functions.

Behavioral: Gamified Tai Chi Program

Interventions

Participants will receive a 12 months standard Traditional Tai Chi training (3 sessions/week, 45 mins/session). This group performs the same physical movements as the experimental group but without any gamification, scoring systems, or interactive game scenarios.

Traditional Tai Chi Group

Participants will receive a 12 months Gamified Tai Chi intervention (3 sessions/week, 45 mins/session). The intervention integrates the MDA (Mechanics, Dynamics, Aesthetics) framework and exergaming elements into traditional Tai Chi movements to target executive functions.

Gamified Tai Chi Group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 9 to 12 years at enrollment.
  • Clinical diagnosis of autism spectrum disorder based on DSM-5 criteria, confirmed by a qualified clinician.
  • Full-scale or equivalent IQ of at least 80.
  • Able to understand basic instructions, imitate movements, and take part in group activities.
  • Able to tolerate low- to moderate-intensity exercise.
  • Educational, rehabilitation, and medication plans expected to remain stable during the study.
  • Written informed consent provided by a legal guardian, with child assent obtained when developmentally appropriate.

You may not qualify if:

  • IQ below 80.
  • Unable to complete basic cognitive or motor assessments.
  • Severe psychiatric or neurological conditions.
  • Exercise contraindications or severe sensory impairments.
  • Safety risks during group activities.
  • Systematic executive-function training, cognitive training, Tai Chi, martial arts, or other structured exercise within the previous 3 months.
  • Medication or rehabilitation plan expected to change during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaozhou Special Education School

Chaozhou, Gaungdong, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, School of Physical Education, Jinan University

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

February 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

June 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because this trial involves a small sample of children with autism spectrum disorder, who are considered a vulnerable population. Given the risk of re identification in this specific clinical and educational setting, and according to the requirements of the ethics committee and the consent obtained from legal guardians, only de identified aggregate results will be reported and shared.

Locations