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 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT04254666
Eligibility Criteria:
Inclusion Criteria:
* measured IQ and adaptive functioning scores of ≤75 as measured by the Kaufman Brief Intelligence Test-2 (KBIT-2) and Vineland Adaptive Behavior Scales-III (VABS-III). A score \> 75 for participants that do not have a syndrome that is associated with ID will be exclusionary. However, participants with such syndromes (e.g., Down syndrome) may have scores above this cut-point but are still classified as having an intellectual disability and thus will qualify for the study.
* Participants must be ambulatory and in sufficiently good health to engage in moderate-to-vigorous physical activity
* able to communicate verbally in English, follow simple instructions, and provide assent.
* approval from the participants' primary care physician and specialists (as necessary) will be required for participation.
Exclusion Criteria:
* uncontrolled medical or significant psychiatric condition
* insulin-dependent diabetes
* physical/orthopedic impairment that would preclude participation in physical activity
* legally blind or deaf
* habitual problem behaviors such as aggression, noncompliance, or leaving an activity area.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
16 Years
Study:
NCT04254666
Study Brief:
Protocol Section:
NCT04254666