游戏化太极拳干预以改善自闭症谱系障碍儿童的执行功能
2026年6月2日 更新者:Ma Ruisi、Jinan University Guangzhou
针对自闭症谱系障碍儿童改善执行功能的游戏化太极拳干预随机对照试验
这项随机对照试验评估了“游戏化太极拳”干预措施对改善自闭症谱系障碍(ASD)儿童执行功能(如抑制控制、工作记忆和认知灵活性)的有效性。
该研究旨在确定将游戏机制(基于机制、动态和美学框架)融入太极拳训练是否比传统太极拳训练或常规护理提供更优越的益处。
大约200名8-15岁的儿童将被随机分配到三组中的一组,为期12个月:
游戏化太极拳组:参与者将参加结合简化太极拳形式与互动任务的课程,如数字追逐游戏和合作挑战,使用基于积分的奖励系统以提高参与度。
传统太极拳组:参与者将学习相同的太极拳动作,但通过标准教学方法,不包含游戏化元素。
对照组:参与者将继续其常规康复或体育课程(等待名单设计)。
对分组分配不知情的评估者将在基线和干预后使用标准化认知任务(如Flanker任务、1-back任务)以及关于社会功能和日常生活技能的行为问卷评估结果。
研究概览
研究类型
介入性
注册 (实际的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Gaungdong
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Chaozhou、Gaungdong、中国
- Chaozhou Special Education School
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
纳入标准:
- 入组时年龄为8至15岁的儿童。
- 根据DSM第五版或ICD第十一修订版,由合格的儿童精神科医生或心理学家确诊为自闭症谱系障碍。
- 具备基本的接受性和表达性语言能力,足以理解简单的口头指令并表达基本需求。
- 根据临床医生或教师的判断,能够参与基于小组的体育活动。
- 由法定监护人提供书面知情同意,并由儿童在其理解范围内提供同意。
排除标准:
- 共存的重度精神障碍,如精神病性障碍或重度心境障碍,或智商低于70的智力障碍。
- 未受控制的癫痫,或可能危及运动安全的医疗状况,包括但不限于显著的心血管疾病、呼吸系统疾病或肌肉骨骼疾病。
- 入组前三个月内接受过专门针对执行功能的系统干预,或定期进行武术或太极训练。
- 根据临床医生或教师的判断,无法遵循口头指令,或存在显著行为问题,导致参与小组活动不安全或不可行。
- 研究团队认为可能干扰干预参与或结果评估的任何其他状况。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:对照组
参与者将按照学校课程安排继续常规康复课程和标准体育课。
在12个月的研究期间不会提供额外的太极拳训练。
研究结束后可能会向他们提供太极拳训练(等候名单设计)。
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实验性的:游戏化太极组
参与者将接受为期12个月的趣味化太极干预(每周3次,每次45分钟)。
该干预将MDA(机制、动态、美学)框架和运动游戏元素融入传统太极动作中,以针对执行功能。
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参与者将接受为期12个月的趣味化太极干预(每周3次,每次45分钟)。
该干预将MDA(机制、动态、美学)框架和运动游戏元素融入传统太极动作中,以针对执行功能进行训练。
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有源比较器:Traditional Tai Chi Group
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.
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参与者将接受为期12个月的标准传统太极拳训练(每周3次,每次45分钟)。
该组执行与实验组相同的身体动作,但没有任何游戏化元素、评分系统或互动游戏场景。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in working memory measured by the 1-back task
大体时间:Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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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.
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Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Change in inhibitory control measured by the Flanker task
大体时间:Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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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.
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Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Change in cognitive flexibility measured by the Dimensional Change Card Sort (DCCS) task
大体时间:Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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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.
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Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in restricted and repetitive behaviors measured by the Repetitive Behavior Scale-Revised (RBS-R)
大体时间:Time Frame: Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Description: Restricted and repetitive behaviors are assessed with the caregiver-rated Repetitive Behavior Scale-Revised (RBS-R), covering stereotyped, self-injurious, compulsive, ritualistic, and sameness behavior and restricted interests.
Each item is scored 0-3, and subscale scores and a total score are derived; the RBS-R total score is the main outcome.
Higher scores indicate more prominent restricted and repetitive behaviors.
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Time Frame: Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Change in aberrant behaviors measured by the Aberrant Behavior Checklist (ABC)
大体时间:Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Autism-related problem behaviors are assessed with the caregiver-rated Aberrant Behavior Checklist (ABC), comprising five subscales: irritability, social withdrawal, stereotyped behavior, hyperactivity and noncompliance, and inappropriate speech.
Each item is scored 0-3, and subscale scores and a total score are derived; the ABC total score is the main outcome.
Higher scores indicate more severe problem behaviors.
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Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Change in emotion regulation difficulties measured by the Difficulties in Emotion Regulation Scale (DERS)
大体时间:Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Description: Difficulties in emotion recognition, acceptance, and regulation are assessed with the caregiver-rated Difficulties in Emotion Regulation Scale (DERS), with subscales for nonacceptance, goal-directed behavior, impulse control, emotional awareness, access to regulation strategies, and emotional clarity.
Subscale scores and a total score are derived; the DERS total score is the main outcome.
Higher total scores indicate greater difficulties in emotion regulation.
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Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Change in overall strengths and difficulties measured by the Strengths and Difficulties Questionnaire (SDQ)
大体时间:Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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Psychological and behavioral problems are assessed with the caregiver-rated Strengths and Difficulties Questionnaire (SDQ), comprising emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior subscales.
The total difficulties score (sum of the emotional symptoms, conduct problems, hyperactivity, and peer problems subscales) is the main outcome.
Higher total difficulties scores indicate greater difficulties, whereas higher prosocial behavior scores indicate more positive social behavior.
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Baseline, week 8, week 16, and week 24 (8 weeks after the end of the 16-week intervention)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年2月1日
初级完成 (实际的)
2026年3月1日
研究完成 (实际的)
2026年3月1日
研究注册日期
首次提交
2025年12月22日
首先提交符合 QC 标准的
2026年1月6日
首次发布 (实际的)
2026年1月7日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年6月2日
最后验证
2026年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025LCLL-141
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
由于本次试验涉及的自闭症谱系障碍儿童样本量较小,且该群体被视为弱势群体,因此不会共享个体参与者数据(IPD)。
考虑到在此特定临床和教育环境中存在重新识别的风险,并根据伦理委员会的要求及法定监护人签署的知情同意书,仅会报告和共享去标识化的汇总结果。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.