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

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 22, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in working memory measured by 1 back task accuracy

    Working memory will be assessed with a computerized 1 back task. The primary outcome will be mean accuracy across all experimental trials. Higher scores indicate better working memory performance.

    Change from baseline to 6 months after randomization

  • Change in inhibitory control measured by Flanker task accuracy

    Inhibitory control will be assessed with a child friendly computerized Flanker task. The primary outcome will be mean accuracy on incongruent trials. Higher scores indicate better inhibitory control.

    Change from baseline to 6 month after randomization

  • Change in cognitive flexibility measured by More Odd Shifting task accuracy

    Cognitive flexibility will be assessed with a computerized More Odd Shifting task that requires switching between judging number magnitude and number parity. The primary outcome will be mean accuracy on mixed blocks that require task switching. Higher scores indicate better cognitive flexibility.

    Change from baseline to 6 months after randomization

Secondary Outcomes (4)

  • Change in social responsiveness measured by the Social Responsiveness Scale-Second Edition (SRS-2)

    Change from baseline to 6 months after randomization

  • Change in functional independence in daily living measured by the WeeFIM

    Change from baseline to 6 months after randomization

  • Change in behavior problems measured by the Child Behavior Checklist for ages 6-18 (CBCL/6-18)

    Change from baseline to 6 months after randomization

  • Change in autism symptom severity measured by the Childhood Autism Rating Scale (CARS)

    Change from baseline to 6 months after randomization

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 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.

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

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 8 to 15 years at enrollment.
  • Clinical diagnosis of autism spectrum disorder based on DSM Fifth Edition or ICD Eleventh Revision, confirmed by a qualified child psychiatrist or psychologist.
  • Basic receptive and expressive language abilities sufficient to understand simple verbal instructions and to express basic needs.
  • Ability to participate in group based physical activities as judged by clinicians or teachers.
  • Written informed consent provided by a legal guardian and assent provided by the child within his or her level of understanding.

You may not qualify if:

  • Coexisting severe psychiatric disorders such as psychotic disorders or major mood disorders, or intellectual disability with an intelligence quotient less than 70.
  • Uncontrolled epilepsy, or medical conditions that may compromise exercise safety, including but not limited to significant cardiovascular disease, respiratory disease, or musculoskeletal disorders.
  • Receipt of systematic interventions specifically targeting executive function or regular martial arts or Tai Chi training during the three months prior to enrollment.
  • Inability to follow verbal instructions, or marked behavior problems that make participation in group activities unsafe or infeasible, as judged by clinicians or teachers.
  • Any other condition that the research team considers likely to interfere with participation in the intervention or with outcome assessment.

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

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

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