Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001188729
Ethics application status
Approved
Date submitted
30/06/2022
Date registered
6/09/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
6/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Vestibular Dysfunction: Prevalence in specialised rehabilitation units and the need for routine vestibular screening on admission
Scientific title
Vestibular Dysfunction: Prevalence in specialised rehabilitation units and the need for routine vestibular screening on admission
Secondary ID [1] 306167 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vestibular Dysfunction 324881 0
Condition category
Condition code
Ear 322318 322318 0 0
Other ear disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The prevalence of vestibular dysfunction will be observed in two specialist rehabilitation units (general rehabilitation unit and brain injury rehabilitation unit).
Participants will be assessed by a research team member in the physiotherapy gym of their unit. Participants will complete the subjective and objective outcome measures, taking approximately 30 min in total. Participants will be assessed only once.
Intervention code [1] 322581 0
Not applicable
Comparator / control treatment
No control group, however the participants in the general rehabilitation unit may be compared with those in the brain injury unit.
Control group
Active

Outcomes
Primary outcome [1] 331850 0
Presence of vestibular dysfunction measured with Vestibular Screening Tool
Timepoint [1] 331850 0
Assessed at one time point
Secondary outcome [1] 404869 0
Presence of central vestibular dysfunction, measured with oculomotor testing
Timepoint [1] 404869 0
Assessed at one timepoint
Secondary outcome [2] 404870 0
Presence of peripheral vestibular dysfunction measured with video head impulse test
Timepoint [2] 404870 0
Assessed at one time point
Secondary outcome [3] 413631 0
Presence of peripheral vestibular dysfunction measured with Hallpike Dix positional testing.
Timepoint [3] 413631 0
one time point

Eligibility
Key inclusion criteria
Partients will be eligible to participate if they are; adults (at least 18 years of age) and current inpatient of BIRU or GARU ward at Princess Alexandra Hospital on the day of vestibular screening assessment .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-English speaking background (NESB) requiring the use of an interpreter to access health services
- Medically unwell and medical clearance not provided on the day of assessment

Significant cervical spine pathology or contraindications to positional or head impulse testing, including:
• Recent cervical spine fracture or cervical disc prolapse
• Atlanto-axial subluxation or instability
• Aplasia of odontoid process
• Carotid sinus syncope
• Arnold Chiari malformation
• Vascular dissection syndromes
• Recent neck trauma that restricts rotation/ torsion
• Severe rheumatoid arthritis
• Known and verified VBI
• Nerve root compression

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size will be dictated by the capacity of each of the involved wards, and by the proportion of patients on those wards who meet eligibility criteria. Across the three GARU wards (Banksia, Cassia, Bunya), there are 70 beds, of which we anticipate to be filled with 85% of patients eligible for the study, based on preliminary discussions with lead physiotherapists in those wards. In BIRU, there are 27 beds. Due to the nature of brain injury and the associated cognitive impairments, we anticipate 84% of patients in BIRU will be eligible. That will provide a total sample size of n=82.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
7/07/2023
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21455 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 36356 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 310558 0
Hospital
Name [1] 310558 0
Princess Alexandra Hospital
Country [1] 310558 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road, Wooloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 311678 0
None
Name [1] 311678 0
Address [1] 311678 0
Country [1] 311678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310137 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 310137 0
Metro South Research Level 7, Translational Research Institute 37 Kent Street Wooloongabba QLD 4102
Ethics committee country [1] 310137 0
Australia
Date submitted for ethics approval [1] 310137 0
21/12/2021
Approval date [1] 310137 0
06/04/2022
Ethics approval number [1] 310137 0
HREC/2021/QMS/79460

Summary
Brief summary
This trial aims to determine the prevalence of vestibular dysfunction in patients admitted to a specialist rehabilitation unit.

Who is it for?
Patients aged 18 or above, current inpatients of BIRU or GARU wards at Princess Alexandra Hospital, Queensland

Study details
All participants will complete the Vestibular Screening Test and then complete objective vestibular testing. All participants from the same ward will be tested consecutively on the same day.

It is hoped that this study will demonstrate the prevalence of vestibular dysfunction within patients of the specialised wards. It is also hoped that the outcomes of this project may have implications for physiotherapists working in subacute rehabilitation units to include vestibular screening as part of their standardised initial physiotherapy assessment on admission. A timely and routine vestibular screening assessment could be a worthwhile adjunct to the standard physiotherapy assessment to guide early and appropriate intervention and achieve optimal rehab outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116606 0
Ms Kate Graving
Address 116606 0
Physiotherapy Department, Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 116606 0
Australia
Phone 116606 0
+617 3176 2401
Fax 116606 0
Email 116606 0
kate.graving@health.qld.gov.au
Contact person for public queries
Name 116607 0
Ms Kate Graving
Address 116607 0
Physiotherapy Department, Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 116607 0
Australia
Phone 116607 0
+617 3176 2401
Fax 116607 0
Email 116607 0
kate.graving@health.qld.gov.au
Contact person for scientific queries
Name 116608 0
Ms Kate Graving
Address 116608 0
Physiotherapy Department, Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 116608 0
Australia
Phone 116608 0
+617 3176 2401
Fax 116608 0
Email 116608 0
kate.graving@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.