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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

falls

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

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]