Advances in Vestibular Rehabilitation

Vestibular Clinical Trial

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'

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144686
• Other study ID #: 19/LO/1066
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: King's College London
• Contact: Reza Razavi
• Phone: 02078483224
• Email: reza.razavi[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vestibular

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Gait Assessment	The primary outcome is the Functional Gait Assessment which is a 10-item test that assesses performance on complex gait tasks (i.e. walking with head turns, stepping over an obstacle or stopping and turning). Scores range from 0 to 30. The highest score is 30 and greater outcomes are indicative of better performance while lower scores are indicative of poorer performance. The Functional Gait Assessment has been validated in healthy people, older adults with a history of falls and balance impairments, and people with a vestibular disorder. The minimal detectable change for Functional Gait Assessment is reported to be 6 points in persons with balance and vestibular disorders. Scores =22/30 identify fall risk and are predictable of falls in community-living older persons within 6 months.	10 minutes
Secondary	Functional Gait Dual-Task Test	The FGA in isolation will always be completed first in (primary outcome measure), followed by the dual-task (DT) test conditions, which will be completed in random order. The cognitive DT condition will involve a numeracy and literacy task and the auditory stimuli will involve restaurant noise.	45 minutes
Secondary	Mini-Balance Evaluation Systems Test	The Mini-Balance Evaluation Test is a measure of dynamic balance (anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait). The Mini-Balance Evaluation Systems Test consists of 14 items, with scores ranging from 0 to 28 points. Higher scores indicate better outcome while lower scores poorer outcome. Scores = 20/32 indicate increased falls risk.	10 minutes
Secondary	Cambridge Neuropsychological Test Automated Battery	Cambridge Neuropsychological Test Automated Battery is a semiautomated computer program that utilizes a touch screen technology and press pad, to assess neurocognitive function. The Cambridge Neuropsychological Test Automated Battery core cognition battery is a validated cognitive assessment system for assessing multiple components of cognitive function, including attention, visual memory, spatial memory, executive function and reaction time.	50 minutes
Secondary	Montreal Cognitive Assessment Tool	The Montreal Cognitive Assessment Tool is a rapid screening tool for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The scores range from 0-30. Higher scores indicate better outcomes while lower scores are indicative of poorer outcomes. It has been recommended that a cut-off scores of 23/30 be used to identify multi-domain cognitive impairment.	5 minutes
Secondary	Speech in Babble Test	The Speech in Babble Test is a low redundancy speech in babble type noise test. The Speech in Babble Test is presented on a calibrated computer using Matlab software. There are 8 in total phonemically and phonetically balanced word lists. The words are presented in the background of a 20-talker babble noise. Two randomly selected monosyllabic consonant vowel consonant word lists in a background of multitalker babble are presented to each ear (i.e. each ear is tested twice). The signal to noise ratio during the test is varied adaptively.	10 minutes
Secondary	Standard pure tone audiometry	Standard pure tone audiometry is considered a 'gold' standard test of audiologic examination. This test will be completed with a portable calibrated audiometer (GSI Pello Standard model with DD45's, IP30 and B81, Serial Number: GS0071085, calibrated by Guymark UK Ltd).	10 minutes
Secondary	Axivity Wrist Band 3-Axis logging accelerometer	Participants' physical activity level will be assessed using a wrist-worn accelerometer, the Axivity Wrist Band 3-Axis logging accelerometer. The Axivity Wrist Band 3-Axis logging accelerometer captures triaxial acceleration data at 100 Hz with a dynamic range of ±8 g and has been widely used in population-based studies to assess physical activity levels.	7 days
Secondary	Activity-specific Balance Confidence Scale	The Activity-specific Balance Confidence Scale is a self-perceived questionnaire with 16 items and assesses balance confidence in daily activities. Scores range from 0 to 100. Higher scores are indicative of better outcome while lower scores indicate poorer outcome. A score =67/100 indicate increased falls risk.	3 minutes
Secondary	Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale, a 14-item scale which assesses non-somatic anxiety and depression symptoms, will also be completed. Scores range from 0 to 21 for each subscale with a score =8 proposed for the identification of caseness, for both depression and anxiety. Higher scores are indicative of poorer outcomes.	3 minutes
Secondary	Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index generates seven component scores: subjective sleep quality, sleep latency, sleep duration habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality while lower scores indicate better outcomes. In distinguishing good and poor sleepers, a global Pittsburgh Sleep Quality Index score >5 yields a sensitivity of 89.6% and a specificity of 86.5%.	3 minutes
Secondary	Epworth Sleepiness Scale	The Epworth Sleepiness Scale is a validated and widely used questionnaire exploring daytime sleepiness. It consists of eight questions that are added together to obtain a single number. Higher scores indicate sleeping disorder while lower scores are indicative of better outcomes. Scores range from 0 to 24. The reference range of 'normal' Epworth Sleepiness Scale scores is 0-10 while Epworth Sleepiness Scale scores of 11-24 represent increasing levels of 'excessive daytime sleepiness'.	3 minutes
Secondary	EQ-5D-5L	The EQ-5D-5L is a generic measure of health status for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.	3 minutes
Secondary	Vertigo Symptom Scale	The VSS is used to assess the frequency and severity of common vestibular (Vertigo Symptom Scale-V; e.g. vertigo, imbalance) and autonomic/somatic (Vertigo Symptom Scale-A; e.g. heart pounding, heavy feeling in the arms or legs) symptoms. Scores range from 0 to 60. Normalised scores range from 0-4, with higher scores indicating a higher (i.e. worse) level of symptoms while lower scores indicate better outcomes.	3 minutes
Secondary	Situational Vertigo Questionnaire	The Situational Vertigo Questionnaire -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 range from 0 to 4. Higher scores indicate poorer outcomes while lower scores are indicative of better outcomes. Scores =0.7/4 indicate visual induced dizziness symptoms.	3 minutes
Secondary	Dizziness Handicap Inventory	The Dizziness Handicap Inventory is a 25-item self-assessment inventory designed to evaluate self-perceived handicap imposed by symptoms of dizziness. It consists of three domains: emotional, functional and physical. Total scores range from 0 to 100, with higher score indicating greater perceived handicap while lower scores are indicative of better performance. Scores between 0-30, 31-60, and 61-100 on the Dizziness Handicap Inventory indicate mild, moderate, and severe perceived handicap respectively, and can differentiate a person's functional abilities.	3 minutes
Secondary	Cognitive and Behavioural Symptom Questionnaire	The Cognitive and Behavioural Symptom Questionnaire is a measure of subjects' cognitive (i.e. beliefs) and behavioural responses to symptoms of their health condition. This measure includes five cognitive (i.e. beliefs) subscales: Symptom Focusing, Catastrophizing, Damaging Beliefs, Fear Avoidance and Embarrassment Avoidance; and two behavioural subscales: All or- Nothing and Avoidance/Rest.	3 minutes
Secondary	The Illness Perception Questionnaire-Revised	The Illness Perception Questionnaire-Revised was used to measure participants' illness perceptions. The Illness Perception Questionnaire-Revised measures the key components in Leventhal's common sense self-regulatory model: Illness identity will measured by asking patients to indicate whether they have experienced and attribute a number of potential symptoms to their dizziness condition. Scores range from 0 to 24 with higher scores indicating increased illness identity while lower scores indicate better outcomes.	3 minutes