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
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-10-24
Study Completion Date
2020-12-31
Brief Summary
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Vestibular rehabilitation therapy (VRT) is an exercise-based programme to encourage central nervous system (CNS) compensation for vestibular dysfunction. There is moderate to strong evidence to support VRT as a safe, effective management in reducing dizziness, vertigo, associated falls and improving quality of life in people with a unilateral and bilateral peripheral vestibular disorder. However, the evidence to discriminate between differing forms of treatment is unclear and, although, approximately 50% to 80% of persons with a vestibular dysfunction achieve significant subjective symptom, gait, dynamic visual acuity and postural stability improvements, full recovery is less common for reasons that currently remain unknown. Thus, further studies are required to identify optimal VRT approaches.
The purpose of this investigation is to identify if the incorporation of dual-task (DT) exercises into a customised VRT programme will have an effect on treatment outcomes in persons with chronic vestibular disorders.
The purpose of this investigation is to identify if the incorporation of dual-task (DT) exercises into a customised VRT programme will have an effect on treatment outcomes in persons with chronic vestibular disorders.
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Detailed Description
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The vestibular system system (i.e. inner ear balance system) is responsible for sending information to the brain about how fast our head is moving as well as about static head position, is necessary for us to be able to see clearly when turning our heads, to navigate in the dark and to balance. Persons who have an inner ear balance disorder will commonly report subjective symptoms of dizziness, imbalance, blurry vision, difficulty concentrating, imbalance and increased falls. Customised vestibular rehabilitation is the mainstay of treatment for persons with an inner ear balance disorder. Eye, head and body movement exercises are included (i.e. walking while turning your head left and right to scan the road) as appropriate for each individual. Moderate to strong evidence exists to support vestibular rehabilitation as a safe, effective management for persons with an inner ear balance disorder. However, there is insufficient evidence to discriminate between differing forms of treatment and although approximately 50% to 80% of persons with a vestibular dysfunction achieve significant symptomatic (i.e. dizziness) and objective improvements with regards to their balance, walking and activities of daily living, some persons do not improve. The reasons for this remain unclear. Thus, although vestibular rehabilitation has been shown to be safe and effective, further studies are required to identify optimal vestibular rehabilitation treatment approaches. Dual-task training (i.e. simultaneously performing two different activities such as walking and talking) has been shown to be beneficial in improving balance and complex walking ability (i.e. walking with head turns) in older adults. However, no studies have investigated dual-tasking training in persons with a vestibular disorder. This is despite evidence showing that the ability to perform complex walking tasks is negatively affected in persons with a vestibular disorder when a cognitive (i.e. "thinking") task is added. Therefore, the purpose of this study is to compare the effect of customised vestibular rehabilitation with and without the incorporation of dual-task (DT) exercises on subjective symptom, objective complex walking tasks, "thinking" function and psychological state. The hypothesis is that customised vestibular rehabilitation incorporating DT exercises will provide greater benefit compared to customised vestibular rehabilitation in isolation.
Conditions
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Vestibular
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Single Blinded Randomised Controlled Trial
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
This RCT has a single mask (assessor blinded). The blinded outcome assessors will collect all the outcome measure data at baseline (week 0) and follow-up (week 6 and 12). The outcome assessor will be asked to record any incidences of unblinding and how this occurred. Blinded outcome assessors will all be trained by Dr Marousa Pavlou or Ms Viktoria Azoidou on how to complete all assessments for parity. During the course of the study, blinded assessors will be MSc students who will work on the project as part of their MSc thesis or other PhD students in the department.
Study Groups
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Group A
Vestibular participants undertaking a single-task vestibular rehabilitation
Group Type
ACTIVE_COMPARATOR
Physiotherapy Rehabilitation
Intervention Type
OTHER
Participants will be randomly allocated, using a random number generator, to a 12-week supervised customised exercise group incorporating VRT programme without (Group A) or with cognitive DT exercises (Group B).
Group B
Vestibular participants undertaking a dual-task vestibular rehabilitation
Group Type
EXPERIMENTAL
Physiotherapy Rehabilitation
Intervention Type
OTHER
Participants will be randomly allocated, using a random number generator, to a 12-week supervised customised exercise group incorporating VRT programme without (Group A) or with cognitive DT exercises (Group B).
Interventions
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Physiotherapy Rehabilitation
Participants will be randomly allocated, using a random number generator, to a 12-week supervised customised exercise group incorporating VRT programme without (Group A) or with cognitive DT exercises (Group B).
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* clinical diagnosis of a peripheral vestibular disorder
* chronic dizziness and/or unsteadiness
* 18 to 80 years' old
* previous vestibular rehabilitation programme completed with partial/no improvement
* willing to participate and to comply with the proposed training and testing regime
* chronic dizziness and/or unsteadiness
* 18 to 80 years' old
* previous vestibular rehabilitation programme completed with partial/no improvement
* willing to participate and to comply with the proposed training and testing regime
Exclusion Criteria
Persons with
* central nervous system involvement, excluding migraine
* 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
* lack of a good grasp of written/spoken English will be excluded.
* central nervous system involvement, excluding migraine
* 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
* lack of a good grasp of written/spoken English will be excluded.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Sponsor Role
collaborator
University College London Hospitals
OTHER
Sponsor Role
collaborator
King's College London
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Viktoria Azoidou
Role: PRINCIPAL_INVESTIGATOR
Ms
Locations
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King's College London
London, , United Kingdom
Site Status
RECRUITING
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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19/LO/1066
Identifier Type: -
Identifier Source: org_study_id
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