Advances in Vestibular Rehabilitation

NCT04144686 | Unknown

• 1 other identifier: 19/LO/1066
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular

Keywords

Vestibular; dual-tasking; Gait; rehabilitation; dizziness

Outcome Measures

Primary Outcomes (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.

  10 minutes

Secondary Outcomes (17)

• Functional Gait Dual-Task Test

  45 minutes

• Mini-Balance Evaluation Systems Test

  10 minutes

• Cambridge Neuropsychological Test Automated Battery

  50 minutes

• Montreal Cognitive Assessment Tool

  5 minutes

• Speech in Babble Test

  10 minutes

Study Arms (2)

Group A

ACTIVE COMPARATOR

Vestibular participants undertaking a single-task vestibular rehabilitation

Other: Physiotherapy Rehabilitation

Group B

EXPERIMENTAL

Vestibular participants undertaking a dual-task vestibular rehabilitation

Other: Physiotherapy Rehabilitation

Interventions

Physiotherapy Rehabilitation 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 A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of a peripheral vestibular disorder
• chronic dizziness and/or unsteadiness
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• University College London Hospitals: collaborator

Study Sites (1)

King's College London

London, SE1 1UL, United Kingdom

RECRUITING

Related Publications (41)

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MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Viktoria Azoidou

  Ms

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Razavi

CONTACT

02078483224; reza.razavi@kcl.ac.uk

Marousa Pavlou

CONTACT

02078486328; marousa.pavlou@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Blinded Randomised Controlled Trial

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 24, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 7, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)