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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT05052905
Eligibility Criteria:
Inclusion Criteria:
* They are ALYN patients undergoing physiotherapy for mild to severe ABI;
* They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility;
* They are between the ages of 8 and 18;
* The time since injury/event is between 10 days and 1 year after the injury/event;
* They are able to maintain stable and dynamic positioning of the head;
* They able to walk with or without assistive equipment, or use a wheelchairs with no need for head support, defined by a LSS (level of sitting scale) score of 3 or greater (scale range: 1-8);
* Are able to understand basic instructions;
* Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.
Exclusion Criteria:
* Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures;
* Untreated benign paroxysmal positional vertigo (BPPV);
* Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak);
* Hearing impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT05052905
Study Brief:
Protocol Section:
NCT05052905