Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000284268
Ethics application status
Approved
Date submitted
2/04/2009
Date registered
15/05/2009
Date last updated
15/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does adding otolith specific exercises to a standard vestibular rehabilitation programme improve outcomes for adults with inner ear dizziness?
Scientific title
Adults with unilateral peripheral vestibular dysfunction undergoing standard vestibular or standard vestibular with added otolith specific exercise rehabilitation - do otolith exercises have an increased benefit in perception of handicap or balance outcomes?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral peripheral vestibular hypofunction 4559 0
Condition category
Condition code
Ear 4851 4851 0 0
Deafness
Physical Medicine / Rehabilitation 5009 5009 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall duration of the treatment intervention is 9 weeks. Participants undergo a full subjective assessment of their condition at baseline and then complete self administered questionnaires that rate their perception of the problem and how this impacts on daily function and quality of life in the week prior to arriving for baseline assessment in Week 0 below.

Week 0 (90 minutes) - Physiotherapist 1 will perform a baseline balance and gait assessment for each participant.

Based on the assessment findings, participants will be given a tailored home exercise program consisting of habituation, gaze stability, and balance exercises. Participants will be asked to complete these exercises taking 10-15 minutes, three times daily for the duration of the 9 week rehabilitation. All participants will be asked to fill in a home exercise diary in order to record completion of the exercise programme.

Weeks 1 and 5 (30 minute review session) - Physiotherapist 2 will review and modify exercises as necessary. Review sessions will take approximately half an hour. A compliance measure for adherence to exercise programmes will be taken at these times for both groups.

At weeks 1 and 5, those participants in the intervention group of standard plus otolith specific vestibular rehabilitation program will be given added exercises to those above involving linear movement of head and/or movement of head position to change orientation with respect to gravity (eg side tilt or bouncing while sitting on a compliant surface). These exercises may add a further 5 minutes to their exercise program.


Week 9 (60 minute review session) – Physiotherapist 1 will repeat the balance and gait assessment and questionnaires.

6 months following baseline assessment (60 minutes) - Physiotherapist 1 will review the exercises and repeat objective outcome measures and questionnaires.
Intervention code [1] 4323 0
Rehabilitation
Comparator / control treatment
the control group will receive the exact same vestibular rehabilitation as described in the intervention/exposure group above except without the additional otolith specific exercises for the same overall duration
Control group
Active

Outcomes
Primary outcome [1] 5707 0
Degree of perceived impairment associated with dizziness via the Dizziness Handicap Inventory
Timepoint [1] 5707 0
Baseline, post treatment, six month follow up
Secondary outcome [1] 241622 0
Computerized Dynamic Posturography - composite score and condition eyes closed+sway reference
Timepoint [1] 241622 0
Baseline, post treatment, six month follow up

Eligibility
Key inclusion criteria
dizziness provoked or aggravated by movement,or, reduced participation in activities of daily life due to imbalance or dizziness due to a unilateral peripheral vestibular dysfunction which may or may not be confirmed by laboratory vestibular function tests
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bilateral vestibular dysfunction, vestibular dysfunction of central origin, confounding neurological or orthopaedic or musculoskeletal conditions which may affect the participants ability to reliably complete the exercise program, insufficient English or cognitive ability to reliably complete the assessment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are referred to a tertiary referral centre - the Vestibular Investigation Unit within the Royal Victorian Eye and Ear Hospital. Enrolment of participants will be done by the chief investigator after completion of vestibular function testing. Random allocation of the subjects to the intervention groups will be performed by an independent investigator. Group allocations will be shuffled and then drawn from a hat held at head height, ensuring that neither subject nor investigator has the ability to identify group allocation prior to selection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by drawing a number from a hat
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4748 0
Hospital
Name [1] 4748 0
Royal Victorian Eye and Ear Hospital
Country [1] 4748 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
32 Gisborne Street
East Melbourne
Victoria 3002
Country
Australia
Secondary sponsor category [1] 4288 0
University
Name [1] 4288 0
Latrobe University
Address [1] 4288 0
Bundoora
Vic 3086
Country [1] 4288 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6788 0
Faculty Human Ethics Committee Latrobe University
Ethics committee address [1] 6788 0
Bundoora
VIC 3086
Ethics committee country [1] 6788 0
Australia
Date submitted for ethics approval [1] 6788 0
Approval date [1] 6788 0
23/04/2008
Ethics approval number [1] 6788 0
FHEC08/51
Ethics committee name [2] 6789 0
Royal Victorian Eye and Ear Hospital Human Ethics Committee
Ethics committee address [2] 6789 0
32 Gisborne Street
East Melbourne
Victoria 3002
Ethics committee country [2] 6789 0
Australia
Date submitted for ethics approval [2] 6789 0
Approval date [2] 6789 0
01/12/2007
Ethics approval number [2] 6789 0
07/756

Summary
Brief summary
The main aim of the project is to compare the response to treatment of patients with vestibular dysfunction between those receiving a standard program of Vestibular Rehabilitation (VR) versus those receiving the standard VR plus additional exercises that specifically target the otolith structures of the inner ear.The research hypotheses are:
1. That additional otolith training exercises will improve the short term effectiveness of a customized program of vestibular rehabilitation, and
2. That the improved short term outcomes from vestibular rehabilitation with additional otolith training exercises will be maintained in the longer term.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29460 0
Address 29460 0
Country 29460 0
Phone 29460 0
Fax 29460 0
Email 29460 0
Contact person for public queries
Name 12707 0
Arimbi Winoto
Address 12707 0
32 Gisborne Street
East Melbourne
Victoria 3002
Country 12707 0
Australia
Phone 12707 0
+61 3 99298270
Fax 12707 0
Email 12707 0
[email protected]
Contact person for scientific queries
Name 3635 0
Arimbi Winoto
Address 3635 0
32 Gisborne Street
East Melbourne
Victoria 3002
Country 3635 0
Australia
Phone 3635 0
+61 3 99298270
Fax 3635 0
Email 3635 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVestibular rehabilitation for unilateral peripheral vestibular dysfunction.2015https://dx.doi.org/10.1002/14651858.CD005397.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.