Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT05503459
Eligibility Criteria:
Inclusion Criteria:
* age 8 - 12 years
* mild to moderate ASD (i.e., level 1-2 support classification) diagnosis from physicians or psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) and Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2)
* non-verbal IQ over 50 using a brief version of the Wechsler Intelligence Scale for Children (Chinese revised) \[C-WISC\]
* able to follow instructions with the assistance of research staff
* able to perform the requested physical intervention, executive function measures and mediator measures with the assistance of the research staff
* no additional regular participation in physical exercise other than school physical education classes for at least one month prior to the study
* novice at riding a two-wheel bicycle (i.e., cannot ride the bicycle alone for more than 10 consecutive seconds).
Exclusion Criteria:
* other medical conditions that limited physical exercise capacities (e.g., asthma, seizure, cardiac disease)
* a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
* suffering from obesity (i.e., \> 95 percentile of age-gender specific BMI cutoff, such that it would be difficult for research staff to catch them if they began to fall when riding
* self-reported color blindness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT05503459
Study Brief:
Protocol Section:
NCT05503459