An interventional study of Exergaming and Aerobic exercise in Autism Spectrum Disorder, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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Among 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital — 14 open to participants now, 16 under way, none of them phase 3. Autism Spectrum Disorder · National Taiwan University Hospital.
Among the 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital, this one is the 7th largest by planned enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2026, is one of 20 with no phase, reaches primary completion later than 14 of the 15 other live ones, and was the 41st registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →14 of the 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital are open now, in 1 country. Recruiting first, the newest first:
National Taiwan University Hospital · Sites in Taiwan
Ages 4–10
National Taiwan University Hospital · Sites in Taiwan
Ages 3–11
National Taiwan University Hospital · Sites in Taiwan
Ages 4–15
National Taiwan University Hospital · Sites in Taiwan
Ages 18–50
National Taiwan University Hospital · Sites in Taiwan
Ages 11–20
By country, each count listing its studies:
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 4 Years to 10 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 105 is above the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 55 across the 20 interventional studies, 249 across the 22 observational. Of the 22 that completed or were terminated, 1 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Taiwan University Hospital is the lead sponsor of 2,617 studies on the registry; 578 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
3 of the studies in Autism Spectrum Disorder by National Taiwan University Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07775937National Taiwan University HospitalSocial Robots and Board Games for Children With Autism Spectrum Disorder | 2026-11-30 |
| NCT06677840National Taiwan University HospitalExploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms | 2027-04-30 |
| NCT05857813National Taiwan University HospitalSocial Skills Training Group Effectiveness in Adolescents With Autism Spectrum Disorder | 2027-07-12 |
Add all 3 to your calendar (.ics) → With an account.
Among the 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
Researchers will compare three different intervention programs:
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This experimental arm including exergame, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances.
Procedure: Exergaming · Procedure: Conventional physical therapy · Behavioral: Behavioral Education
This experimental arm including interval-based aerobic exercise, motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances.
Procedure: Aerobic exercise · Procedure: Conventional physical therapy · Behavioral: Behavioral Education
This experimental arm including motor intervention focusing on fundamental motor skills, and behavioral education on sleep disturbances.
Procedure: Conventional physical therapy · Behavioral: Behavioral Education
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 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 therapy focusing on fundamental motor skills including locomotion and ball skills.
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-test, on the 8th week, on the 12th week
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.
Time frame: 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.)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-test, on the 8th week, on the 12th week
Started May 2026 (actual). Primary completion is estimated for Jul 2028, 26 months after the start.
Of 802 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 26 months is close to that.
Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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