Comparison of Optokinetic Stimulation Treatments (NCT04649268) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Optokinetic Stimulation Treatments
United Kingdom24 participantsStarted 2021-12-28
Plain-language summary
Persons with a vestibular (e.g. inner ear) disorder often report visual induced dizziness (ViD) symptom (i.e. postural and/or gait instability, dizziness, disorientation) provocation or exacerbation in environments with busy or conflicting visual motion including crowds and supermarkets. ViD is frequently associated with high disability levels, prolonged illness and poorer clinical outcome. Thus, effective treatment is a priority. Vestibular rehabilitation incorporating structured exposure to Optokinetic Stimulation (OKS) (e.g. a form of computer based intervention that involves the observation of moving visual targets to encourage visual scanning) significantly improves ViD symptoms with similar improvement noted for both 'low-tech' OKS provided via a DVD or a 'high-tech', expensive, full-field stimulus. No studies have investigated if 'lower-tech', cheaper Virtual Reality (VR) systems may be beneficial in treating ViD symptoms and whether these VR systems are more effective than an OKS DVD. The first aim of this work is to compare the effect of an OKS DVD vs "lower-tech" VR system on ViD symptoms in persons with a chronic peripheral vestibular disorder aged 18-50 years old. This study may help to identify more optimal treatment strategies in persons with a vestibular disorder.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. clinical diagnosis of a peripheral vestibular disorder;
✓. chronic dizziness and/or unsteadiness;
✓. 18 to 50 years old;
✓. no previous rehabilitation or previous VRT programme completed with partial/no improvement;
✓. willing to participate and to comply with the proposed training and testing regime; and
✓. 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
✕. central nervous system involvement, excluding migraine. However, patients with severe migraine (\> 3 migrainous headaches monthly) will be excluded.
✕
What they're measuring
1
Situational Characteristics Questionnaire (SCQ)
Timeframe: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
. fluctuating symptoms, for example, active Ménière disease;
✕. acute orthopaedic disorders influencing balance control and gait;
✕. a score of \< 23/30 on the MoCA;
✕. a score of \>15/21 on the HADS for the depression component indicating significant depression symptoms;
✕. inability to attend sessions;
✕. diagnosis of neurological disorder;
✕. 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