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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT04649268
Eligibility Criteria:
Inclusion Criteria:
1. clinical diagnosis of a peripheral vestibular disorder;
2. chronic dizziness and/or unsteadiness;
3. 18 to 50 years old;
4. no previous rehabilitation or previous VRT programme completed with partial/no improvement;
5. willing to participate and to comply with the proposed training and testing regime; and
6. current SCQ score \>0,7/4. Patient diagnosis will be based on clinical history and/or neuro-otological findings, according to published normative data and limits. Persons with Benign Paroxysmal Positional Vertigo (BPPV) will be included, in the study, due to the persistence of imbalance and dizziness after BPPV resolution. The diagnosis of migraine will be made according to the International Headache Society Criteria for Migraine as well as Neuhauser Criteria for VM.
Exclusion Criteria:
Persons with:
1. central nervous system involvement, excluding migraine. However, patients with severe migraine (\> 3 migrainous headaches monthly) will be excluded.
2. fluctuating symptoms, for example, active Ménière disease;
3. acute orthopaedic disorders influencing balance control and gait;
4. a score of \< 23/30 on the MoCA;
5. a score of \>15/21 on the HADS for the depression component indicating significant depression symptoms;
6. inability to attend sessions;
7. diagnosis of neurological disorder;
8. currently attending or has completed a rehabilitation programme targeting balance and/or dizziness in the past year or is currently part of a clinical trial testing a medicinal product. These factors may skew both the assessment scores and treatment outcome and for this reason they are listed as exclusion criteria; and
9. lack of a good grasp of written/spoken English will be excluded. The latter due to the need to complete multiple questionnaires and the lack of funding for interpreters.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04649268
Study Brief:
Protocol Section:
NCT04649268