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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT05014503
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary written informed consent of the participant or their legally authorized representative
2. A confirmed diagnosis of CVI
3. Dutch-speaking
4. A developmental age between 3 and 12 years.
5. Sufficient motor abilities (cerebral palsy with a Gross Motor Function Classification level \<V)
6. Sufficient fine motor function to handle a tablet or laptop (Manual Ability Classification System level \<4)
7. Able to express their experiences with the game.
8. A visual acuity of more than 0.2 (Snellen notation)
Exclusion Criteria:
1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
3. Children not speaking or understanding Dutch language
4. Children with limited gross motor function abilities (GMFCS V)
5. Children with limited hand function (MACS 4-5)
6. Children unable to express their experiences with the game due to serious speech disorders, deafness or autism.
7. A visual acuity of less than 0.2 (Snellen notation)
8. Serious behavioural problems limiting participation to the games
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT05014503
Study Brief:
Protocol Section:
NCT05014503