Autism Spectrum DisorderNCT07789457
Exercise Interventions for Children With Autism Spectrum Disorder
A study testing Exergaming, Aerobic exercise and Conventional physical therapy in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this clinical trial is to find out whether exergame and aerobic exercise can improve sleep, movement skills, thinking abilities, and brain activity in children with autism spectrum disorder (ASD). This study aims to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Exergaming, Aerobic exercise and Conventional physical therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 4-10 year (48-131 months).
- Have a clinical diagnosis of ASD.
- Able to follow two-step order.
- With sleep disturbances for more than 3 days per week in past 3 months reported by child's caregiver.
- The primary caregiver must be aged 20 years or older and capable of reading and writing in Chinese.
Who cannot join
- Having physical disabilities or congenital anomalies of extremities.
- Loss of vision or hearing function.
- The child has been diagnosed with genetic disorders (e.g., Down syndrome or Fragile X syndrome).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Early Childhood Behavior Laboratory, School and Graduate Institute of Physical Therapy, National Taiwan University,
Taipei
Yen-Tzu Wu, PT, Ph.D, 886-2-33668161, yenwu@ntu.edu.tw
About this study
Official title: Exercise Interventions for Children With Autism Spectrum Disorder: Effects of Aerobic Exercise and Exergaming Intervention on Sleep, Motor, Executive Function and Brian Activation
The purpose of this clinical trial is to find out whether exergame and aerobic exercise can improve sleep, movement skills, thinking abilities, and brain activity in children with autism spectrum disorder (ASD).
This study aims to answer the following questions:
Read more
- Can exergame and aerobic exercise improve sleep, movement skills, and thinking abilities in children with ASD?
- Can exergame and aerobic exercise change brain activity in children with ASD?
Researchers will compare three different intervention programs:
- Exergame combined with motor and behavioral intervention.
- Aerobic exercise combined with motor and behavioral intervention.
- Motor and behavioral intervention only. By comparing these three groups, researchers hope to determine whether adding exergames or aerobic exercise provides additional benefits for children with ASD.
Participants will:
- Attend one intervention session each week for 8 weeks. Depending on the group they are assigned to, they will receive either exergames combined with motor and behavioral intervention, aerobic exercise combined with motor and behavioral intervention, or motor and behavioral intervention only.
- Complete a home exercise program twice a week for 12 weeks.
- Visit the laboratory three times for assessments: before the intervention begins, at the end of Week 8, and at the end of Week 12.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Exergaming, Aerobic exercise, Conventional physical therapy, Behavioral Education
- Keywords
- Exergaming, Aerobic exercise, Sleep, Motor skills, Executive function, Brain activation, fNIRS
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingProcedure or surgery
Exergaming is defined as a type of active video game (or non-immersive virtual reality) that requires players to engage in full-body movements, involving moderate-to-vigorous physical activity.
Aerobic exerciseProcedure or surgery
Aerobic exercise (AE) will apply interval-based training model, which serve as a feasible form of AE with intermittent, high-intensity, short-duration characteristics, and alternates between periods of activity and rest.
Conventional physical therapyProcedure or surgery
Conventional physical therapy focusing on fundamental motor skills including locomotion and ball skills.
Behavioral EducationBehavioural
Behavioral education focusing on sleep hygiene and behavioral strategies (e.g., extinction, reinforcement, developing appropriate bedtime and consistent bedtime routine) to facilitate specific strategies for enhancing child's sleep qualities
| Study group | Role | What they receive |
|---|---|---|
| Exergaming group | Experimental | This experimental arm including exergame, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances. Receives: Procedure: Exergaming; Procedure: Conventional physical therapy; Behavioral: Behavioral Education |
| Interval based Aerobic Exercise group | Experimental | This experimental arm including interval-based aerobic exercise, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances. Receives: Procedure: Aerobic exercise; Procedure: Conventional physical therapy; Behavioral: Behavioral Education |
| Control group | Active comparator | This experimental arm including motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances. Receives: Procedure: Conventional physical therapy; Behavioral: Behavioral Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamental motor skills - Test of Gross Motor Development, Third Edition (TGMD-3)
The TGMD-3 is a standardized, norm-referenced test for testing gross motor skills development and quality for children aged 3 to 10 years 11 months. The scales consist of Locomotor and Ball skills subtests. The Locomotion subtest includes 6 items, and Ball skills subtest includes 7 items. Each item is scored with either 0 or 1 in 3 to 5 specific performance criteria. A score of 0 indicates that the performance criterion was not achieved, whereas a score of 1 indicates that the performance criterion was achieved. The score of Locomotion subtest ranges from 0 to 46, and the score of Ball skills subtest ranges from 0 to 54. Higher scores indicate better performance and greater maturity in the respective skills and overall fundamental motor skills. Raw scores for the subtests and total score can be converted to T-scores. Subtest T-scores have a mean of 10 (standard deviation = 3), and total score T-scores have a mean of 100 (standard deviation = 15).
Measured: Pre-test, on the 8th week, on the 12th week
Fundamental motor skill - Bruininks-Oseretsky Test of Motor Proficiency, Third Edition (BOT-3)
The BOT-3 is a standardized, norm-referenced test for testing motor proficiency for children aged 4 to 25 years 11 months. The scales consist of Fine motor (FM) and Gross motor (GM) composites. The FM composite induces 32 items from 4 subscales: Fine motor precision, Fine motor integration, Manual dexterity, and Upper-limb coordination. The GM composite induces 31 items from 4 subscales: Bilateral coordination, Balance, Strength, and Dynamic movement. Raw scores are converted to point scores using a comparison table, which are summed and converted to standard scores. Standard scores range from 40 to 160, with a mean of 100 (SD = 15). Higher scores indicate better performance.
Measured: Pre-test, on the 8th week, on the 12th week
Actigraph sleep assessment
Wrist-worn actigraphy will be used to measure sleep parameters including sleep efficiency (%), total time in bed (minutes), total sleep time (minutes), sleep latency (minutes), wake after sleep onset (minutes), number of awakenings (times), and average awakening duration (minutes).
Sleep efficiency was the primary reported outcome and was calculated as (total sleep time / total time in bed) × 100. Total sleep time was calculated as total time in bed minus the sum of sleep latency and wake after sleep onset. The other actigraphy parameters were used to characterize sleep patterns and to derive the primary outcome.
Measured: Pre-test, on the 12th week
Executive functions - Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P)
BRIEF-P is a set of questionnaires for the report from parents or teachers, designed to evaluate executive functions (EF) for child's ages 2 to 5 years 11 months.BRIEF-P consists of 63 items related to behavioral manifestations of EFs, rated on a 3-point scale indicating whether the behavior occurs never (1), sometimes (2), or often (3). The items are divided into five scales of EF (Inhibition, Shift, Emotional control, Working memory, and Planning/ Organization). Three indexes comprising scales are included: (1) Inhibitory Self-Control Index; (2) Flexibility Index; (3) Emergent Metacognition Index. The items of the five clinical scales also provide a Global Executive Composite. Higher scores indicate greater dysregulation in behaviors associated with EF, reflecting a worse outcome. For all BRIEF-P scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated.
Measured: Pre-test, on the 8th week, on the 12th week
Executive functions - Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
The BRIEF-2 is a set of questionnaires report from parents, designed to evaluate executive functions (EF) for child's ages 5 to 18 years. The BRIEF-2 consists of 63 items related to behavioral manifestations of EF, rated on a 3-point scale indicating whether the behavior occurs never (1), sometimes (2), or often (3). The items are divided into nine scales of EF (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/ Organize, Task-Monitor, and Organization of Materials). Three indexes comprising nine scales are included: (1) Behavior Regulation Index; (2) Emotion Regulation Index; (3) Cognitive Regulation Index.
Higher scores indicate greater dysregulation in behaviors associated with EF, reflecting a worse outcome. For all BRIEF-2 scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated.
Measured: Pre-test, on the 8th week, on the 12th week
Secondary outcomes (7)
Adaptive behavior - Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
The Vineland-3 is a parent-reported scale to assess a child's actual adaptive capabilities and behavioral performance within their daily environment. Which yields scores for 3 adaptive domains: Communication, Daily Living Skills, and Socialization and 9 subdomains. Furthermore, optional Motor Skills and Maladaptive Behavior domains are available for flexible use. Items are scored on a scale of 0 (Never), 1 (Sometimes), and 2 (Usually or Often). Total scores are expressed as raw scores and v-scores, with higher scores indicating better adaptive behavior.
Measured: Pre-test, on the 8th week, on the 12th week
Brain activation - Functional Near-Infrared Spectroscopy (fNIRS)
The brain activation of cerebral oxygenation will be monitored during two types dual motor-cognitive and dual motor tasks. A multichannel wearable fNIRS imaging system will be used to detect the hemodynamics of the bilateral prefrontal cortex (PFC), supplementary motor area (SMA), and premotor cortex (PMC). (PFC plays an important role in executive function; SMA is responsible for planning motor action and guiding self-initiated motor control; PMC is an area which integrates information about the target and the body-part to plan a forthcoming action.)
Measured: Pre-test, on the 12th week
Attention - Conners Kiddie Continuous Performance Test, 2nd Edition (K-CPT 2)
Attentional performance in children aged 4 to 7 years was assessed using the K-CPT 2, a computerized task designed to evaluate sustained attention and inhibitory control. During the test, children were required to respond to target stimuli and withhold responses to non-target stimuli over a continuous period of time. Key outcome measures included omission errors (failures to respond to target stimuli), commission errors (responses to non-target stimuli), reaction time, and reaction time variability, which together reflect attentional capacity, impulsivity, and response consistency. Each outcome measure is presented as a T-score ranging from 30 to 90, with a mean of 50 (standard deviation = 10). A T-score above 60 indicates a clinical elevation in attentional problems.
Measured: Pre-test, on the 8th week, on the 12th week
Attention - Conners Continuous Performance Test, Third Edition (CPT-3)
Attentional performance in children and adolescent aged above 8 years was assessed using the CPT-3, a computerized task designed to evaluate sustained attention and inhibitory control. During the test, children were required to respond to target stimuli and withhold responses to non-target stimuli over a continuous period of time. Key outcome measures included omission errors (failures to respond to target stimuli), commission errors (responses to non-target stimuli), reaction time, and reaction time variability, which together reflect attentional capacity, impulsivity, and response consistency. Each outcome measure is presented as a T-score ranging from 30 to 90, with a mean of 50 (standard deviation = 10). A T-score above 60 indicates a clinical elevation in attentional problems.
Measured: Pre-test, on the 8th week, on the 12th week
Autism-related symptoms - Social Responsiveness Scale, Second Edition (SRS-2)
The SRS-2 measures social ability of children from 2.5 to 18 years old, which is used primarily in individuals with ASD, others who have social impairments, and their family members. There are four forms of SRS-2 for a specific age group, each with 5 subscales including social awareness, social cognition, social communication, social motivation, as well as restricted interests and repetitive behavior. There are totally 65 items for each form, and each item is scored on a 4-point Likert-scale: 1 ("not true"), 2 ("sometimes true), 3 (often true), and 4 ("almost always true"). Total scores are expressed in raw and T-scores. This study will use the Preschool and School-Age Forms which are completed by parents. The SRS-2 has been reported to have good internal consistency, test-retest reliabilities, and inter-rater reliabilities.
Measured: Pre-test, on the 8th week, on the 12th week
Sleep problems - Children Sleep Health Questionnaire for Autism (CHSQ-Autism)
CHSQ-Autism is complete by the caregiver and consists of 23 items divided into 4 domains: sleep initiation duration, sleep anxiety/co-sleeping, night wakings/parasomnias, and daytime alertness. Each item is rated on a 3-point scale: 3 (Usually, 5~7 days/week), 2 (Sometimes, 2~4 days/week), and 1 (Rarely, 0~1 day/week). The total score of the CHSQ-autism is the sum of 23 items, ranging from 23 to 69. In the study, a cutoff score of above 41 was taken to indicate positive.
Measured: Pre-test, on the 8th week, on the 12th week
Sleep problems - Chinese version of OSA-18
OSA-18 is completed by the caregiver and consists of 18 items divided into 5 subscales: sleep disturbance, physical symptoms, emotional distress, daytime functioning, and caregiver concerns. Each item is rated on a 7-point scale. The total score of the OSA-18 is the sum of all 18 items, ranging from 18 (no effect on quality of life) to 126 (significant negative effect). A cutoff score of above 63 was taken to indicate positive status in Taiwanese preschoolers aged 3-5 years, given its greater accuracy in identifying abnormal values.
Measured: Pre-test, on the 8th week, on the 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start17 May 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789457
- Sponsor's protocol ID
- 202412056RINC
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Interventions for Children With Autism Spectrum Disorder: Effects of Aerobic Exercise and Exergaming Intervention on Sleep, Motor, Executive Function and Brian Activation
- ClinicalTrials.gov ID
- NCT07789457
- Acronym / sponsor ID
- 202412056RINC
- Conditions
- Autism Spectrum Disorder
- Keywords
- Exergaming, Aerobic exercise, Sleep, Motor skills, Executive function, Brain activation, fNIRS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 May 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to find out whether exergame and aerobic exercise can improve sleep, movement skills, thinking abilities, and brain activity in children with autism spectrum disorder (ASD).
This study aims to answer the following questions:
- Can exergame and aerobic exercise improve sleep, movement skills, and thinking abilities in children with ASD?
- Can exergame and aerobic exercise change brain activity in children with ASD?
Researchers will compare three different intervention programs:
- Exergame combined with motor and behavioral intervention.
- Aerobic exercise combined with motor and behavioral intervention.
- Motor and behavioral intervention only. By comparing these three groups, researchers hope to determine whether adding exergames or aerobic exercise provides additional benefits for children with ASD.
Participants will:
- Attend one intervention session each week for 8 weeks. Depending on the group they are assigned to, they will receive either exergames combined with motor and behavioral intervention, aerobic exercise combined with motor and behavioral intervention, or motor and behavioral intervention only.
- Complete a home exercise program twice a week for 12 weeks.
- Visit the laboratory three times for assessments: before the intervention begins, at the end of Week 8, and at the end of Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exergaming group | Experimental | Procedure: Exergaming, Procedure: Conventional physical therapy, Behavioral: Behavioral EducationThis experimental arm including exergame, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances. |
| Interval based Aerobic Exercise group | Experimental | Procedure: Aerobic exercise, Procedure: Conventional physical therapy, Behavioral: Behavioral EducationThis experimental arm including interval-based aerobic exercise, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances. |
| Control group | Active comparator | Procedure: Conventional physical therapy, Behavioral: Behavioral EducationThis experimental arm including motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 4-10 year (48-131 months).
- Have a clinical diagnosis of ASD.
- Able to follow two-step order.
- With sleep disturbances for more than 3 days per week in past 3 months reported by child's caregiver.
- The primary caregiver must be aged 20 years or older and capable of reading and writing in Chinese.
Key exclusion criteria (3 listed)
- Having physical disabilities or congenital anomalies of extremities.
- Loss of vision or hearing function.
- The child has been diagnosed with genetic disorders (e.g., Down syndrome or Fragile X syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingExergaming is defined as a type of active video game (or non-immersive virtual reality) that requires players to engage in full-body movements, involving moderate-to-vigorous physical activity. | Procedure or surgery | Exergaming group |
| Aerobic exerciseAerobic exercise (AE) will apply interval-based training model, which serve as a feasible form of AE with intermittent, high-intensity, short-duration characteristics, and alternates between periods of activity and rest. | Procedure or surgery | Interval based Aerobic Exercise group |
| Conventional physical therapyConventional physical therapy focusing on fundamental motor skills including locomotion and ball skills. | Procedure or surgery | Control group, Exergaming group, Interval based Aerobic Exercise group |
| Behavioral EducationBehavioral education focusing on sleep hygiene and behavioral strategies (e.g., extinction, reinforcement, developing appropriate bedtime and consistent bedtime routine) to facilitate specific strategies for enhancing child's sleep qualities | Behavioural | Control group, Exergaming group, Interval based Aerobic Exercise group |
Primary outcome
Fundamental motor skills - Test of Gross Motor Development, Third Edition (TGMD-3)
Time frame: Pre-test, on the 8th week, on the 12th week
The TGMD-3 is a standardized, norm-referenced test for testing gross motor skills development and quality for children aged 3 to 10 years 11 months. The scales consist of Locomotor and Ball skills subtests. The Locomotion subtest includes 6 items, and Ball skills subtest includes 7 items. Each item is scored with either 0 or 1 in 3 to 5 specific performance criteria. A score of 0 indicates that the performance criterion was not achieved, whereas a score of 1 indicates that the performance criterion was achieved. The score of Locomotion subtest ranges from 0 to 46, and the score of Ball skills subtest ranges from 0 to 54. Higher scores indicate better performance and greater maturity in the respective skills and overall fundamental motor skills. Raw scores for the subtests and total score can be converted to T-scores. Subtest T-scores have a mean of 10 (standard deviation = 3), and total score T-scores have a mean of 100 (standard deviation = 15).
Fundamental motor skill - Bruininks-Oseretsky Test of Motor Proficiency, Third Edition (BOT-3)
Time frame: Pre-test, on the 8th week, on the 12th week
The BOT-3 is a standardized, norm-referenced test for testing motor proficiency for children aged 4 to 25 years 11 months. The scales consist of Fine motor (FM) and Gross motor (GM) composites. The FM composite induces 32 items from 4 subscales: Fine motor precision, Fine motor integration, Manual dexterity, and Upper-limb coordination. The GM composite induces 31 items from 4 subscales: Bilateral coordination, Balance, Strength, and Dynamic movement. Raw scores are converted to point scores using a comparison table, which are summed and converted to standard scores. Standard scores range from 40 to 160, with a mean of 100 (SD = 15). Higher scores indicate better performance.
Actigraph sleep assessment
Time frame: Pre-test, on the 12th week
Wrist-worn actigraphy will be used to measure sleep parameters including sleep efficiency (%), total time in bed (minutes), total sleep time (minutes), sleep latency (minutes), wake after sleep onset (minutes), number of awakenings (times), and average awakening duration (minutes). Sleep efficiency was the primary reported outcome and was calculated as (total sleep time / total time in bed) × 100. Total sleep time was calculated as total time in bed minus the sum of sleep latency and wake after sleep onset. The other actigraphy parameters were used to characterize sleep patterns and to derive the primary outcome.
Executive functions - Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P)
Time frame: Pre-test, on the 8th week, on the 12th week
BRIEF-P is a set of questionnaires for the report from parents or teachers, designed to evaluate executive functions (EF) for child's ages 2 to 5 years 11 months.BRIEF-P consists of 63 items related to behavioral manifestations of EFs, rated on a 3-point scale indicating whether the behavior occurs never (1), sometimes (2), or often (3). The items are divided into five scales of EF (Inhibition, Shift, Emotional control, Working memory, and Planning/ Organization). Three indexes comprising scales are included: (1) Inhibitory Self-Control Index; (2) Flexibility Index; (3) Emergent Metacognition Index. The items of the five clinical scales also provide a Global Executive Composite. Higher scores indicate greater dysregulation in behaviors associated with EF, reflecting a worse outcome. For all BRIEF-P scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated.
Executive functions - Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Pre-test, on the 8th week, on the 12th week
The BRIEF-2 is a set of questionnaires report from parents, designed to evaluate executive functions (EF) for child's ages 5 to 18 years. The BRIEF-2 consists of 63 items related to behavioral manifestations of EF, rated on a 3-point scale indicating whether the behavior occurs never (1), sometimes (2), or often (3). The items are divided into nine scales of EF (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/ Organize, Task-Monitor, and Organization of Materials). Three indexes comprising nine scales are included: (1) Behavior Regulation Index; (2) Emotion Regulation Index; (3) Cognitive Regulation Index. Higher scores indicate greater dysregulation in behaviors associated with EF, reflecting a worse outcome. For all BRIEF-2 scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated.
7 secondary outcomes
Adaptive behavior - Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time frame: Pre-test, on the 8th week, on the 12th week
Brain activation - Functional Near-Infrared Spectroscopy (fNIRS)
Time frame: Pre-test, on the 12th week
Attention - Conners Kiddie Continuous Performance Test, 2nd Edition (K-CPT 2)
Time frame: Pre-test, on the 8th week, on the 12th week
Attention - Conners Continuous Performance Test, Third Edition (CPT-3)
Time frame: Pre-test, on the 8th week, on the 12th week
Autism-related symptoms - Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Pre-test, on the 8th week, on the 12th week
Sleep problems - Children Sleep Health Questionnaire for Autism (CHSQ-Autism)
Time frame: Pre-test, on the 8th week, on the 12th week
Sleep problems - Chinese version of OSA-18
Time frame: Pre-test, on the 8th week, on the 12th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming, Aerobic exercise and Conventional physical therapy in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen-Tzu Wu, PT, Ph.D (886-2-33668136, yenwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundamental motor skills - Test of Gross Motor Development, Third Edition (TGMD-3) (time frame: Pre-test, on the 8th week, on the 12th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.