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VestibularNCT04144686

Advances in Vestibular Rehabilitation

A study testing Physiotherapy Rehabilitation in people with Vestibular, run by King's College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Vestibular
What is being tested?
Physiotherapy Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
24 Oct 2019to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • King's College London

    London, SE1 1UL

    Marousa Pavlou, 02078486328, marousa.pavlou@kcl.ac.uk

    Viktoria Azoidou, 02078486679 ext. Azoidou, viktoria.azoidou@kcl.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

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'

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.

Read the 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.

Conditions
Vestibular
Being tested
Physiotherapy Rehabilitation
Keywords
Vestibular, dual-tasking, Gait, rehabilitation, dizziness
Medical subject headings
Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physiotherapy RehabilitationOther

    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).

Study groups in NCT04144686
Study groupRoleWhat they receive
Group AActive comparatorVestibular participants undertaking a single-task vestibular rehabilitation
Receives: Other: Physiotherapy Rehabilitation
Group BExperimentalVestibular participants undertaking a dual-task vestibular rehabilitation
Receives: Other: Physiotherapy Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 minutes

Secondary outcomes (17)
  1. 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.

    Measured: 45 minutes

  2. 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.

    Measured: 10 minutes

  3. 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.

    Measured: 50 minutes

  4. 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.

    Measured: 5 minutes

  5. 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.

    Measured: 10 minutes

  6. 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).

    Measured: 10 minutes

  7. 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.

    Measured: 7 days

  8. 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.

    Measured: 3 minutes

  9. 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.

    Measured: 3 minutes

  10. 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%.

    Measured: 3 minutes

  11. 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'.

    Measured: 3 minutes

  12. 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.

    Measured: 3 minutes

  13. 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.

    Measured: 3 minutes

  14. 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.

    Measured: 3 minutes

  15. 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.

    Measured: 3 minutes

  16. 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.

    Measured: 3 minutes

  17. 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.

    Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start24 Oct 2019
  3. Primary completionAug 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single Blinded Randomised Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144686
Sponsor's protocol ID
19/LO/1066
Status last verified
Jul 2019
First submitted
28 Oct 2019
Last updated
7 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will be processed in accordance with the General Data Protection Regulation 2016 (GDPR). All information collected will be kept strictly confidential and stored anonymously on password protected computers used only by research staff. Data will be stored securely in accordance with the Data Protection Act (1998) and the General Data Protection Regulations which came into effect on 25 May 2018. IPD will not be passed on to anyone outside of participant's medical care team. Stored, anonymised data may be used for future medical and health-related studies. IPD will be retained for 10 years after it has been collected.

Publications

  • Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.

    PubMed 26913496
  • Smith PF. Age-Related Neurochemical Changes in the Vestibular Nuclei. Front Neurol. 2016 Mar 3;7:20. doi: 10.3389/fneur.2016.00020. eCollection 2016.

    PubMed 26973593
  • Topuz O, Topuz B, Ardic FN, Sarhus M, Ogmen G, Ardic F. Efficacy of vestibular rehabilitation on chronic unilateral vestibular dysfunction. Clin Rehabil. 2004 Feb;18(1):76-83. doi: 10.1191/0269215504cr704oa.

    PubMed 14763722
  • Arnold SA, Stewart AM, Moor HM, Karl RC, Reneker JC. The Effectiveness of Vestibular Rehabilitation Interventions in Treating Unilateral Peripheral Vestibular Disorders: A Systematic Review. Physiother Res Int. 2017 Jul;22(3). doi: 10.1002/pri.1635. Epub 2015 Jun 25.

    PubMed 26111348
  • Lacour M, Bernard-Demanze L, Dumitrescu M. Posture control, aging, and attention resources: models and posture-analysis methods. Neurophysiol Clin. 2008 Dec;38(6):411-21. doi: 10.1016/j.neucli.2008.09.005. Epub 2008 Oct 9.

    PubMed 19026961
  • Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.

    PubMed 18058946
  • Carson N, Leach L, Murphy KJ. A re-examination of Montreal Cognitive Assessment (MoCA) cutoff scores. Int J Geriatr Psychiatry. 2018 Feb;33(2):379-388. doi: 10.1002/gps.4756. Epub 2017 Jul 21.

    PubMed 28731508
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820
  • Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

    PubMed 11832252
  • Davies RA, Luxon LM. Dizziness following head injury: a neuro-otological study. J Neurol. 1995 Mar;242(4):222-30. doi: 10.1007/BF00919595.

    PubMed 7798121
  • Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

    PubMed 23771276
  • Lempert T, Olesen J, Furman J, Waterston J, Seemungal B, Carey J, Bisdorff A, Versino M, Evers S, Newman-Toker D. Vestibular migraine: diagnostic criteria. J Vestib Res. 2012;22(4):167-72. doi: 10.3233/VES-2012-0453.

    PubMed 23142830
  • Neuhauser H, Leopold M, von Brevern M, Arnold G, Lempert T. The interrelations of migraine, vertigo, and migrainous vertigo. Neurology. 2001 Feb 27;56(4):436-41. doi: 10.1212/wnl.56.4.436.

    PubMed 11222783
  • Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

    PubMed 15449976
  • Marchetti GF, Lin CC, Alghadir A, Whitney SL. Responsiveness and minimal detectable change of the dynamic gait index and functional gait index in persons with balance and vestibular disorders. J Neurol Phys Ther. 2014 Apr;38(2):119-24. doi: 10.1097/NPT.0000000000000015.

    PubMed 24637931

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy Rehabilitation in people with Vestibular, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Reza Razavi (02078483224, reza.razavi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Gait Assessment (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04144686, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.

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