Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000052134
Ethics application status
Approved
Date submitted
4/01/2019
Date registered
15/01/2019
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does physiotherapy assessment and management of vertigo in people admitted to sub-acute rehabilitation after an injurious fall decrease the rate of falls in the first three months at home after discharge?
Scientific title
Does physiotherapy assessment and management of vestibular dysfunction in patients admitted to sub-acute rehabilitation after an injurious fall reduce the rate of falls in the first three months after discharge home?
Secondary ID [1] 296967 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 310929 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309593 309593 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. An initial vestibular physiotherapy screen to identify patients with a vestibular dysfunction will be undertaken within a week of admission on all patients admitted to the sub-acute rehabilitation unit following an injurious fall.
a) This screen will include
i. An oculomotor assessment - clinical assessment of eye movement control in sitting
ii. Clinical assessment of the vestibular-ocular reflex in sitting - the ability to move the head while maintaining focus on a specific point (stable gaze)
iii. Clinical assessment of dynamic visual acuity in sitting - a comparison of the ability to read standard Snellen eye chart keeping the head still and then while moving the head from side to side
iv. Positional testing to screen for Benign Paroxysmal Positional Vertigo (BPPV) with the standard clinical assessments of the Hall-pike Dix or side-lying test (lying down from sitting) and the roll test in supine

b) the clinical assessment will take a maximum of 30 minutes
c) the assessment will be undertaken in the physiotherapy gym by an appropriately trained staff physiotherapist

2. An appropriately trained staff physiotherapist will provide individualised vestibular rehabilitation protocols to all patients with a vestibular dysfunction on screening. This will be undertaken during usual physiotherapy rehabilitation sessions in the gym.
i. if BPPV is identified, the appropriate repositioning manouvres will be undertaken second daily until resolution of symptoms, taking a maximum of 15 minutes per session. No other vestibular rehabilitation exercises will commence until the BPPV has been resolved.
ii. if a vestibular system deficit is identified, appropriate gaze stability and / or vestibular rehabilitation exercises will be undertaken, for a maximum of 30 minutes per day, every day during the rehabilitation admission
iii. if a vestibular deficit is not identified, the participant will be allocated to the control group and will undertake usual sub-acute physiotherapy rehabilitation as detailed below
iii. all exercise interventions will be initially undertaken one-on-one and face to face, during the physiotherapy rehabilitation session in the physiotherapy gym. If participants are safe and able to undertake specific gaze stability exercises independently, each will be provided with an exercise sheet to enable independent practice.
iv. participants will keep an individual exercise record to monitor adherence
v. frequency and duration of all interventions will be at the discretion of the treating physiotherapist

3. 72 hours before discharge, a final vestibular assessment will be undertaken for those participants who were identified as having a vestibular dysfunction on initial assessment to ensure BPPV has not recurred or developed.

4. Discharge written home exercise programs incorporating appropriate vestibular rehabilitation exercises if appropriate will be provided by the treating physiotherapist, and will include the same format exercise record that has been used during the inpatient admission.
Intervention code [1] 313239 0
Rehabilitation
Comparator / control treatment
The control group will be comprised of those participants who had no vestibular dysfunction identified on initial vestibular physiotherapy assessment.
These participants will undertake usual sub-acute physiotherapy rehabilitation as directed by their treating staff physiotherapist. This program will include a daily program functional strengthening, dynamic balance exercises and gait retraining. An attendance log will be maintained.
Discharge written home exercise programs will be provided by the treating physiotherapist, and will include the same format exercise record that has been used during the inpatient admission.
Control group
Active

Outcomes
Primary outcome [1] 318553 0
Proportion of patients in each of the three groups who have slips and/or trips and/or falls
Groups:
1. no vestibular dysfunction identified
2. Benign paroxysmal positional vertigo (BPPV)
3. Peripheral and / or central vestibular dysfunction identified +/- BPPV
Number and frequency of slips and/or trips and/or falls during the first three months at home as recorded in a Falls Diary and confirmed during phone call follow-up
Timepoint [1] 318553 0
three months (13 weeks) after discharge from sub-acute rehabilitation
Primary outcome [2] 318554 0
change in falls risk from discharge (score out of 30)
Assessed using the Functional Gait Assessment, a ten-item standardised test of functional mobility with each task individually scored (0-3). Maximum possible score is 30, A score less than 22/30 indicating a risk of falls
Timepoint [2] 318554 0
three months (13 weeks) after discharge from sub-acute rehabilitation
Secondary outcome [1] 365367 0
Change in quality of life at three months after discharge
Quality of Life measured by the EQ-5D-5L, a patient rated measure of health
Timepoint [1] 365367 0
three months (13 weeks) after discharge from sub-acute rehabilitation
Secondary outcome [2] 365368 0
Change in self-rated balance confidence at three months after discharge
Measured using the ABC6 version of the Activities Balance Confidence Scale: a self-rated scale of balance confdence during functional activieis (0-100)
Timepoint [2] 365368 0
three months (13 weeks) after discharge from sub-acute rehabilitation
Secondary outcome [3] 365369 0
Change in functional mobility at three months post-discharge measured with the Timed Up and Go test: a functional measure of the ability to stand up from a chair, walk 3 metres, turn and return to sit down

Timepoint [3] 365369 0
three months (13 weeks) after discharge from sub-acute rehabilitation
Secondary outcome [4] 365370 0
Change in gait velocity at three months post-discharge measured with the 10 metre walk test which measures the time taken to walk 10 metres using usual walking aid if required.
Timepoint [4] 365370 0
three months (13 weeks) after discharge from sub-acute rehabilitation
Secondary outcome [5] 365371 0
proportion of participants requiring vestibular physiotherapy review after discharge due to recurrence of BPPV, (BPPV has a recurrence rate of up to 50% in the elderly)
The Vestibular Screening tool (VST), a four item screening tool, will be administered by a research assistant during phone call follow-up weekly for the first four weeks after discharge, then at 8 weeks and 13 weeks to identify any participants who may have had a recurrence of BPPV and require a physiotherapy review earlier than the planned three month post-discharge follow-up.
Timepoint [5] 365371 0
up to three months (13 weeks) after discharge from sub-acute rehabilitation

Eligibility
Key inclusion criteria
i. Over 50 years of age
ii. Able to provide informed consent, or if MSQ<23, have a carer or family member who is willing and able to provide consent
iii. Rehabilitation admission resulting from an injurious fall
iv. Planned discharge back to home
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Intellectual or developmental disability or acquired brain injury such as a stroke
ii. Patients with an MSQ of <23 will not be excluded unless they are unable to appropriately follow single stage commands and/or if they do not have a carer or family member to provide consent on their behalf
iii. Planned discharge to a residential aged care facility

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
On average 5 patients per week are admitted to Brighton Health Campus for rehabilitation following an injurious fall. If three are recruited per week, this gives an estimated recruitment of 120 participants over the 9 months of planned recruitment. Published data on the prevalence of vestibular dysfunction in a subacute rehabilitation cohort like this does not yet exist but my clinical experience suggests that at least half of participants will have a vestibular dysfunction identified on clinical assessment. analysis will be undertaken with the guidance and advice of the statistician in the School of Allied Health, Faculty of Health Sciences, Australian Catholic University,
i. Descriptive statistics will be used to present the demographics and falls rates of the total group and percentage of patients in each of the three clinical classifications (no vestibular dysfunction, BPPV, vestibular dysfunction)
ii. Means (SDs) will be used to present the discharge and follow-up clinical outcome measures and questionnaires. Repeated measures general linear models and post-hoc analysis will determine any differences in clinical performance and self-report measures for all three clinical groups at both time points.
iii. Spearman Rank Order correlations will be undertaken to explore the associations between FGA scores, clinical outcomes measures and the number and frequency of falls amongst the three groups
iv. The associations between falls rates, balance confidence and quality of life will be explored amongst the three groups. To determine the clinical importance of between group differences, the ‘no vestibular dysfunction’ group will be considered the usual care group and used as a benchmark for comparison with outcomes in both vestibular dysfunction and BPPV clinical groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/12/2019
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12819 0
Brighton Health Campus - Brighton
Recruitment postcode(s) [1] 25289 0
4017 - Brighton

Funding & Sponsors
Funding source category [1] 301536 0
Government body
Name [1] 301536 0
Queensland Health
Country [1] 301536 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
School of Allied Health
McCauley at Brisbane Campus
Australian Catholic University
1100 Nudgee Road,
Banyo. 4014, Qld
Country
Australia
Secondary sponsor category [1] 301239 0
University
Name [1] 301239 0
Professor Suzanne Kuys
Address [1] 301239 0
Head of School of Allied Health
Australian Catholic University
McCauley at Banyo campus
1100 Nudgee Road
Banyo Qld. 4104
Country [1] 301239 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302274 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 302274 0
The Prince Charles Hospital
Building 14
Rode Road, Chermside. Qld 4032
Ethics committee country [1] 302274 0
Australia
Date submitted for ethics approval [1] 302274 0
11/01/2018
Approval date [1] 302274 0
24/05/2018
Ethics approval number [1] 302274 0
HREC/18?QPCH/12
Ethics committee name [2] 302275 0
ACU Human Research Ethics Committee
Ethics committee address [2] 302275 0
Office of Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus (MacKillop)
Tenison Woods House
8-20 Napier Street-Level 16 (532.16)
North Sydney NSW 2060
Ethics committee country [2] 302275 0
Australia
Date submitted for ethics approval [2] 302275 0
21/05/2018
Approval date [2] 302275 0
28/05/2018
Ethics approval number [2] 302275 0

Summary
Brief summary
Dizziness when moving (vertigo) is a common symptom of dysfunction in the vestibular system of the inner ear. Problems with this inner ear system can result on poor balance and falls. Trained vestibular physiotherapists can identify and manage common causes of vertigo and balance dysfunction. However, people who have been admitted to hospital following an injurious fall may not be able to move quickly enough to provoke vertigo, and therefore may not be identified as needing physiotherapy vestibular assessment and management, The aim of this study is to determine whether the identification and management of vestibular dysfunction in patients admitted to sub-acute rehabilitation after a fall decreases the rate of falls in the first three months back home after discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89658 0
Dr Ann Rahmann
Address 89658 0
School of Allied Health
Australian Catholic University
Brisbane Campus (McCauley)
1100 Nudgee Road, Banyo, Qld. 4014
Country 89658 0
Australia
Phone 89658 0
+61 7 3623 7754
Fax 89658 0
Email 89658 0
[email protected]
Contact person for public queries
Name 89659 0
Dr Ann Rahmann
Address 89659 0
School of Allied Health
Australian Catholic University
Brisbane Campus (McCauley)
1100 Nudgee Road, Banyo, Qld. 4014
Country 89659 0
Australia
Phone 89659 0
+61 7 3623 7754
Fax 89659 0
Email 89659 0
[email protected]
Contact person for scientific queries
Name 89660 0
Dr Ann Rahmann
Address 89660 0
School of Allied Health
Australian Catholic University
Brisbane Campus (McCauley)
1100 Nudgee Road, Banyo, Qld. 4014
Country 89660 0
Australia
Phone 89660 0
+61 7 3623 7754
Fax 89660 0
Email 89660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data
When will data be available (start and end dates)?
Beginning 3 months and ending 1 year following main results publication
Available to whom?
on a case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
for systematic review / meta-analyses, and / or to achieve aims of the approved proposal
How or where can data be obtained?
access subject to approval by Principal Investigator and requirement to sign data access agreement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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