Clinical trial NCT04144686: Advances in Vestibular Rehabilitation
Official title: 'Effectiveness of Customised Vestibular Rehabilitation With and Without Additional Dual-Task Training in Persons With a Chronic Vestibular Disorder. A Randomised Controlled Trial'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular
Keywords: Vestibular
dual-tasking
Gait
rehabilitation
dizziness
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: University College London Hospitals
First posted: 2019-10-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blinded Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Functional Gait Assessment
timeFrame: 10 minutes
Secondary outcomes:
measure: Functional Gait Dual-Task Test
timeFrame: 45 minutes
measure: Mini-Balance Evaluation Systems Test
timeFrame: 10 minutes
measure: Cambridge Neuropsychological Test Automated Battery
timeFrame: 50 minutes
measure: Montreal Cognitive Assessment Tool
timeFrame: 5 minutes
measure: Speech in Babble Test
timeFrame: 10 minutes
measure: Standard pure tone audiometry
timeFrame: 10 minutes
measure: Axivity Wrist Band 3-Axis logging accelerometer
timeFrame: 7 days
measure: Activity-specific Balance Confidence Scale
timeFrame: 3 minutes
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 3 minutes
measure: Epworth Sleepiness Scale
timeFrame: 3 minutes
measure: EQ-5D-5L
timeFrame: 3 minutes
measure: Vertigo Symptom Scale
timeFrame: 3 minutes
measure: Situational Vertigo Questionnaire
timeFrame: 3 minutes
measure: Dizziness Handicap Inventory
timeFrame: 3 minutes
measure: Cognitive and Behavioural Symptom Questionnaire
timeFrame: 3 minutes
measure: The Illness Perception Questionnaire-Revised
timeFrame: 3 minutes
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Ms
name: Viktoria Azoidou
role: PRINCIPAL_INVESTIGATOR
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