- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322952
Gamified Tai Chi Intervention to Improve Executive Function in Children With Autism Spectrum Disorder
Randomized Controlled Trial of a Gamified Tai Chi Intervention to Improve Executive Function in Children With Autism Spectrum Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gaungdong
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Chaozhou, Gaungdong, China
- Chaozhou Special Education School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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).
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Active Comparator: Traditional Tai Chi Group
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.
|
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.
|
|
Experimental: Gamified 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in working memory measured by 1 back task accuracy
Time Frame: Change from baseline to 6 months after randomization
|
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.
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Change from baseline to 6 months after randomization
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Change in inhibitory control measured by Flanker task accuracy
Time Frame: Change from baseline to 6 month after randomization
|
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.
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Change from baseline to 6 month after randomization
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Change in cognitive flexibility measured by More Odd Shifting task accuracy
Time Frame: Change from baseline to 6 months after randomization
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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.
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Change from baseline to 6 months after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in social responsiveness measured by the Social Responsiveness Scale-Second Edition (SRS-2)
Time Frame: Change from baseline to 6 months after randomization
|
Social functioning will be assessed using the caregiver rated Social Responsiveness Scale-Second Edition (SRS-2).
The primary outcome for this measure will be the SRS-2 total T score.
Higher scores indicate more severe social communication and interaction difficulties.
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Change from baseline to 6 months after randomization
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Change in functional independence in daily living measured by the WeeFIM
Time Frame: Change from baseline to 6 months after randomization
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Activities of daily living will be evaluated with the Functional Independence Measure for Children (WeeFIM).
The outcome will be the WeeFIM total score summarizing self care, mobility and cognition items.
Higher scores indicate greater functional independence in everyday life.
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Change from baseline to 6 months after randomization
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Change in behavior problems measured by the Child Behavior Checklist for ages 6-18 (CBCL/6-18)
Time Frame: Change from baseline to 6 months after randomization
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Behavior problems will be assessed using the parent rated Child Behavior Checklist for ages 6-18 (CBCL/6-18).
The main outcomes will be T scores on attention related and hyperactivity related scales.
Higher T scores indicate more severe behavior problems.
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Change from baseline to 6 months after randomization
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Change in autism symptom severity measured by the Childhood Autism Rating Scale (CARS)
Time Frame: Change from baseline to 6 months after randomization
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Autism symptom severity will be assessed using the Childhood Autism Rating Scale (CARS).
The outcome will be the CARS total score based on clinician ratings across core symptom domains.
Higher scores indicate more severe autism related symptoms.
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Change from baseline to 6 months after randomization
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025LCLL-141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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