Comparison of Optokinetic Stimulation Treatments

NCT04649268 | Unknown

• 1 other identifier: REC Reference: 20/LO/1244
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Vestibular Disorder

Keywords

optokinetic stimulation; visually induced dizziness; vestibular; virtual reality; Oculus Quest headset

Outcome Measures

Primary Outcomes (1)

• Situational Characteristics Questionnaire (SCQ)

  This is the primary outcome. The Situational Characteristics Questionnaire (SCQ) -shortened version measures how frequently symptoms are provoked or exacerbated in environments with visual vestibular mismatch or intense visual motion (e.g. travelling on escalators, crowds, scrolling computer screens). Scores ≥0.7/4 indicate visual induced dizziness symptoms.

  Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

Secondary Outcomes (7)

• Functional Gait Assessment (FGA)

  Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

• Rod and Disc Test

  Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

• LEGSys™ and Balansens (Biosensics, MA, USA)

  Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

• Montreal Cognitive Assessment (MoCA) Tool

  Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

Study Arms (2)

Optokinetic stimulation treatment with visual motion DVDs

ACTIVE COMPARATOR

Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with visual motion DVDs

Other: Group A

Optokinetic stimulation treatment with Virtual Reality

EXPERIMENTAL

Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with Virtual Reality environments delivered with headset (e.g. Oculus Quest headset)

Device: Group B

Interventions

Group B DEVICE

The C2 CARE C2 Physio 2019.2 has been developed for physiotherapy rehabilitation purposes including vestibular disorders. Virtual reality environments will be provided via the VR Oculus Quest headset as part of the OKS exposure incorporated within a customised VRT programme. Participants will attend 45 minute individualised supervised sessions once weekly for 8 weeks. Participants in this rehabilitation group will also have a home-based exercise programme to practise on days not attending clinic. The home-based programme will incorporate customised VRT exercises with exposure to VR environments using the VR Oculus Quest headset.

Also known as: C2CARE Class I medical device: virtual environments, C2CARE PSY: C2 Physio 2019.2, Optokinetic stimulation treatment with Virtual Reality

Optokinetic stimulation treatment with Virtual Reality

Group A OTHER

Optokinetic stimulation treatment delivered through visual motion DVDs. Individualised 45 minute supervised sessions will occur for this group also once weekly for 8 weeks together with a home-based customised VRT programme incorporation the DVD to practise on days not attending clinic. Participants will have to use the OKS DVD for their exercises at home daily for 8 weeks as part of the prescribed home exercise programme.

Also known as: Optokinetic stimulation treatment with visual motion DVDs

Optokinetic stimulation treatment with visual motion DVDs

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of a peripheral vestibular disorder;
• chronic dizziness and/or unsteadiness;
• 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.

You may not qualify if:

• Persons with:
• central nervous system involvement, excluding migraine. However, patients with severe migraine (\> 3 migrainous headaches monthly) will be excluded.
• 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;
• 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.

Sponsors & Collaborators

• King's College London: lead
• University College, London: collaborator

Study Sites (1)

King's College London

London, SE1 1UL, United Kingdom

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a pilot study and 24 participants will be randomised into one of two rehabilitation groups incorporating OKS treatment with Optokinetic DVD (Group A) or VR headset (e.g. Oculus Quest headset) (Group B).

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 2, 2020
• Study Start: December 28, 2021
• Primary Completion: December 28, 2021
• Study Completion: June 30, 2022
• Last Updated: September 1, 2021

Record last verified: 2020-11

Locations

GB (1)