Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-12-28
Study Completion Date
2022-06-30
Brief Summary
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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.
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Detailed Description
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Background People with ViD report symptom (i.e. postural and/or gait instability, dizziness, disorientation) provocation or exacerbation in environments with busy or conflicting visual motion including crowds, supermarkets and scrolling computer screens. Visual dependence and impaired sensory re-weighting have been identified as main contributors to balance problems in persons with vestibular disorders and are frequently associated with high disability levels, prolonged illness, and poorer clinical outcome in adults with vestibular dysfunction including vestibular migraine.
Evidence suggests that ViD symptoms respond well to rehabilitation incorporating structured exposure to OKS. Treatment with gradual, progressive exposure to OKS in combination with static and dynamic functional balance exercises has been shown to improve visual dependency, functional balance and gait as well as symptoms provoked or exacerbated in busy visual environments, such as crowds, in persons with a vestibular disorder. It is believed that improvements in ViD following treatment with OKS is due to sensory-reweighting which is the ability of CNS to adapt its relative reliance on a specific sensory modality for purposes of orientation depending on environmental conditions, task demands and/ or pathology.
During neuroimaging studies, exposure to visual OKS, in the absence of vestibular stimulation, results in consistent activation of cortical regions involved in the control of visual motion processing and eye movement, and deactivation of parieto-insular vestibular cortices indicating a reciprocally inhibitory visual-vestibular interaction. Similarly, stimulation of multisensory vestibular cortex areas results in bilateral deactivation in visual and somatosensory cortex areas. These interactions may have a functional significance and indicate a sensor re-weighting process with greater weight given to the more reliable input thus suppressing the possible mismatch between contrasting sensory information. It is believed that the recurring exposure to conflicting visual input promotes reduced visual reliance and facilitates a more effective use of vestibule-proprioceptive cues through sensory re-weighting.
However, the exact mechanisms involved in sensory re-weighting in persons with visual induced dizziness remain poorly understood.
Finally, previous work has demonstrated that low tech OKS provided via a DVD produces the same level of improvement as a more expensive, full field stimulus. Findings for the effect of virtual reality (VR) on ViD are inconclusive. Furthermore, to date only VR provided via an immersive projection theatre, often referred to as a CAVE has been used to investigate its effect on ViD. This equipment is very expensive and available only within a specialist centre. No studies have investigated if 'lower-tech' VR such as VR headset and specifically, Oculus Quest headset, may be beneficial in treatment of ViD at a much lower cost. The use of 'lower-tech' OKS equipment is promising, more widely available to clinical practice and safe to be used at home by the patients for rehabilitation purposes. However, it is not known if one type of 'lower-tech' equipment may provide greater benefit compared to another.
Purpose of the study The proposed pilot study is a non-commercial-PhD student project. The purpose of this investigation is to compare two types of OKS based VRT for the improvement of ViD in persons with a chronic vestibular disorder.
Objectives/Aims of the study The primary objective of this study is to compare the effect of two types of optokinetic stimulation (OKS) based vestibular rehabilitation (VRT) programmes on Situational Characteristics Questionnaire (SCQ) scores in persons with a chronic vestibular disorder who experience ViD aged 18-50 years old.
The secondary objectives are to compare the pre-post treatment effect of two types of OKS based VRT on subjective dizziness, psychological state, balance confidence and objective gait, balance and ViD symptoms.
Primary Hypothesis Both types of OKS will provide significant improvement on SCQ scores, but improvement with VR will be greater.
Secondary Hypothesis VRT with VR Oculus Quest headset may provide greater treatment outcome on gait and balance control, participant's subjective symptoms, psychological state and cognitive function.
Evidence suggests that ViD symptoms respond well to rehabilitation incorporating structured exposure to OKS. Treatment with gradual, progressive exposure to OKS in combination with static and dynamic functional balance exercises has been shown to improve visual dependency, functional balance and gait as well as symptoms provoked or exacerbated in busy visual environments, such as crowds, in persons with a vestibular disorder. It is believed that improvements in ViD following treatment with OKS is due to sensory-reweighting which is the ability of CNS to adapt its relative reliance on a specific sensory modality for purposes of orientation depending on environmental conditions, task demands and/ or pathology.
During neuroimaging studies, exposure to visual OKS, in the absence of vestibular stimulation, results in consistent activation of cortical regions involved in the control of visual motion processing and eye movement, and deactivation of parieto-insular vestibular cortices indicating a reciprocally inhibitory visual-vestibular interaction. Similarly, stimulation of multisensory vestibular cortex areas results in bilateral deactivation in visual and somatosensory cortex areas. These interactions may have a functional significance and indicate a sensor re-weighting process with greater weight given to the more reliable input thus suppressing the possible mismatch between contrasting sensory information. It is believed that the recurring exposure to conflicting visual input promotes reduced visual reliance and facilitates a more effective use of vestibule-proprioceptive cues through sensory re-weighting.
However, the exact mechanisms involved in sensory re-weighting in persons with visual induced dizziness remain poorly understood.
Finally, previous work has demonstrated that low tech OKS provided via a DVD produces the same level of improvement as a more expensive, full field stimulus. Findings for the effect of virtual reality (VR) on ViD are inconclusive. Furthermore, to date only VR provided via an immersive projection theatre, often referred to as a CAVE has been used to investigate its effect on ViD. This equipment is very expensive and available only within a specialist centre. No studies have investigated if 'lower-tech' VR such as VR headset and specifically, Oculus Quest headset, may be beneficial in treatment of ViD at a much lower cost. The use of 'lower-tech' OKS equipment is promising, more widely available to clinical practice and safe to be used at home by the patients for rehabilitation purposes. However, it is not known if one type of 'lower-tech' equipment may provide greater benefit compared to another.
Purpose of the study The proposed pilot study is a non-commercial-PhD student project. The purpose of this investigation is to compare two types of OKS based VRT for the improvement of ViD in persons with a chronic vestibular disorder.
Objectives/Aims of the study The primary objective of this study is to compare the effect of two types of optokinetic stimulation (OKS) based vestibular rehabilitation (VRT) programmes on Situational Characteristics Questionnaire (SCQ) scores in persons with a chronic vestibular disorder who experience ViD aged 18-50 years old.
The secondary objectives are to compare the pre-post treatment effect of two types of OKS based VRT on subjective dizziness, psychological state, balance confidence and objective gait, balance and ViD symptoms.
Primary Hypothesis Both types of OKS will provide significant improvement on SCQ scores, but improvement with VR will be greater.
Secondary Hypothesis VRT with VR Oculus Quest headset may provide greater treatment outcome on gait and balance control, participant's subjective symptoms, psychological state and cognitive function.
Conditions
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Peripheral Vestibular Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Optokinetic stimulation treatment with visual motion DVDs
Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with visual motion DVDs
Group Type
ACTIVE_COMPARATOR
Group A
Intervention Type
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.
Optokinetic stimulation treatment with Virtual Reality
Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with Virtual Reality environments delivered with headset (e.g. Oculus Quest headset)
Group Type
EXPERIMENTAL
Group B
Intervention Type
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.
Interventions
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Group B
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.
Intervention Type
DEVICE
Group A
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.
Intervention Type
OTHER
Other Intervention Names
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C2CARE Class I medical device: virtual environments
C2CARE PSY: C2 Physio 2019.2
Optokinetic stimulation treatment with Virtual Reality
Optokinetic stimulation treatment with visual motion DVDs
Eligibility Criteria
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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.
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;
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.
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;
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University College, London
OTHER
Sponsor Role
collaborator
King's College London
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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King's College London
London, , United Kingdom
Site Status
Countries
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United Kingdom
References
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Reference Type
RESULT
Other Identifiers
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REC Reference: 20/LO/1244
Identifier Type: -
Identifier Source: org_study_id
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Vestibular Rehabilitation and Otolith Dysfunction
NCT02652442
COMPLETED
NA
Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
NCT03553264
UNKNOWN
NA
Virtual Reality in Children With and Without Vestibular Deficits
NCT04791748
RECRUITING
NA
Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation
NCT00146952
UNKNOWN
PHASE1
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
NCT03618199
COMPLETED
NA
Dose of Vestibular Rehabilitation for Vestibular Hypofunction
NCT04851184
TERMINATED
NA
Verticality Perception Assessed by the Haptic Vertical
NCT02980432
COMPLETED
NA
Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV
NCT03624283
UNKNOWN
NA
Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy
NCT04226976
SUSPENDED
NA
Sensory Training for Visual Motion Sickness
NCT04420949
COMPLETED
NA
Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Peripheral Vestibular Dysfunction Patients
NCT05002374
RECRUITING
NA
2-dimensional Versus 3-dimensional Virtual Reality Game Training in BPPV
NCT05021939
COMPLETED
NA
Human Visual and Vestibular Motion Perception Study
NCT04142697
RECRUITING
NA
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
NCT04396132
COMPLETED
NA
Transcranial Vibrating System for Improving Vestibular Physical Therapy
NCT03795168
TERMINATED
NA
Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
NCT04678167
RECRUITING
NA
Visuo-Vestibular Adaptation in Virtual Reality
NCT06213792
COMPLETED
App-supported Vestibular Rehabilitation (RCT)
NCT06350669
COMPLETED
NA