Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device).
- Who it may be relevant to
- Registry conditions: Healthy Volunteer. Basic parameters: 6 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years.
Overview
The purpose of this study is to strengthen the normative QbMobile data for children and adolescents age 6-11 years to allow for a more robust and accurate representation when comparing a patient's QbMobile performance with the appropriate normative reference group.
Detailed description
Participants will be recruited and referred from selected clinics' general population databases, local schools, youth centers and organizations, as well as other general practitioners within the surrounding area.
Participants will be pre-screened via an online questionnaire completed by their parent/legal guardian designed to capture diagnostic history and general demographic information. Access to the questionnaire will be initiated by scanning a QR code on the study flyer that will be visibly posted at locations listed above.
Parents or legal guardians will be asked to provide a reliable phone number within the pre-screening questionnaire, which will be used by the research team to follow up and verify the information submitted in the questionnaire. Once eligibility is confirmed through both the questionnaire and phone verification, participants will be scheduled for enrollment in the study.
On the scheduled study day, participants will complete a 10-minute QbMobile test.
Interventions
- Device Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
Participants will complete a non-invasive, 10-minute digital tests using the QbMobile Investigational Device. The test objectively measure cognitive performance and activity levels.
Primary outcome measures
- Establishment of Normative Statistics for QbMobile Performance [Time frame: 1 QbMobile test at the clinic visit (Day 1)]
Secondary outcome measures (1)
- Exploratory Analysis of Additional Domain Parameters [Time frame: 1 QbMobile test at the clinic visit (Day 1)]
Eligibility criteria
Inclusion criteria
- Provide informed consent from parent/legal guardians and assent for all study participants for the QbMobile study;
- Aged > 6 years and < 11 years old;
- Have no documented or suspected current or lifetime diagnosis of ADHD;
- Have adequate sensory and physical ability to complete QbMobile;
Exclusion criteria
- Intellectual disability designated by IQ<75;
- Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease), unmanaged psychiatric illness;
- Has other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
- Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07330960 · 00091260 QB25-02