Exercise Interventions for Children With Autism Spectrum Disorder

NCT07789457 | Recruiting

• 1 other identifier: 202412056RINC
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can exergame and aerobic exercise improve sleep, movement skills, and thinking abilities in children with ASD?
2. 2.Can exergame and aerobic exercise change brain activity in children with ASD?
3. 3.Exergame combined with motor and behavioral intervention.
4. 4.Aerobic exercise combined with motor and behavioral intervention.
5. 5.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.
6. 6.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.
7. 7.Complete a home exercise program twice a week for 12 weeks.
8. 8.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

Keywords

Exergaming; Aerobic exercise; Sleep; Motor skills; Executive function; Brain activation; fNIRS

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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.

  Pre-test, on the 8th week, on the 12th week

Secondary Outcomes (7)

• Adaptive behavior - Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

  Pre-test, on the 8th week, on the 12th week

• Brain activation - Functional Near-Infrared Spectroscopy (fNIRS)

  Pre-test, on the 12th week

• Attention - Conners Kiddie Continuous Performance Test, 2nd Edition (K-CPT 2)

  Pre-test, on the 8th week, on the 12th week

• Attention - Conners Continuous Performance Test, Third Edition (CPT-3)

  Pre-test, on the 8th week, on the 12th week

• Autism-related symptoms - Social Responsiveness Scale, Second Edition (SRS-2)

  Pre-test, on the 8th week, on the 12th week

Study Arms (3)

Exergaming group

EXPERIMENTAL

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

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.

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.

Procedure: Conventional physical therapy; Behavioral: Behavioral Education

Interventions

Exergaming PROCEDURE

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.

Exergaming group

Aerobic exercise PROCEDURE

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.

Interval based Aerobic Exercise group

Conventional physical therapy PROCEDURE

Conventional physical therapy focusing on fundamental motor skills including locomotion and ball skills.

Control group; Exergaming group; Interval based Aerobic Exercise group

Behavioral Education BEHAVIORAL

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

Control group; Exergaming group; Interval based Aerobic Exercise group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Early Childhood Behavior Laboratory, School and Graduate Institute of Physical Therapy, National Taiwan University,

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Exergaming; Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yen-Tzu Wu, PT, Ph.D

CONTACT

886-2-33668136; yenwu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 27, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

TW (1)