Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000502437
Ethics application status
Approved
Date submitted
7/05/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring blood pressure continuously whilst mobilising people after severe stroke
Scientific title
Continuous blood pressure monitoring while mobilising severe acute stroke patients: a pilot study assessing real time blood pressure (BP) changes with activities of usual care
Secondary ID [1] 314388 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 337393 0
Condition category
Condition code
Stroke 333769 333769 0 0
Haemorrhagic
Stroke 333770 333770 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The continuous BP monitoring device prototype has been developed by Monash University engineering.
The sensor device consists of:
(i) Electrodes and leads:
*A multi-point chest electrode (adhered via standard ECG Electrodes) placed in the middle of the sternum
(ii) Central processing unit (CPU)
*A circuit that generates and receives the signal to and from the chest electrodes
(iii) Laptop computer
*Used to input the patient’s demographic data, non-invasive arm cuff BP readings, visualise
data obtained from the CPU, and host the algorithms used to deduct BP.

The participant's BP will be monitored continuously only whilst undertaking mobilising activities within a physiotherapy session (see below). It will be attached when the physiotherapy session commences, and removed when the physiotherapy session concludes (maximum 30 minute session).
The device will be attached to the patient via the ECG electrodes by an experienced neurological physiotherapist who has undertaken training with the bio-engineering team.

Mobilisation
Mobilisation will be undertaken as part of a patient's routine post-stroke physiotherapy care by a qualified physiotherapist. As recommended by published Australian Stroke Guidelines, participants will be mobilised by a physiotherapist by being assisted to roll over in bed, sit up on the edge of the bed, stand up from the bed, stand next to the bed, and walk within their ability. Mobilisation, as per standard practice, will cease when a participant has reached their maximum functional level within the session e.g. if they need maximum assistance to sit on the edge of the bed, the mobilisation session will cease at that time and the patient will be returned to lying down in bed. This is considered standard and 'best practice' in acute care of people following stroke and no change will occur to participants in this study other than the addition of continuous BP monitoring throughout.
Mobilisation sessions (as per usual care) typically last for (maximum) 30 minutes per session.
Mobilisation sessions (as per usual care) typically occur daily (Monday-Friday). For the trial, participants will engage in a data collection session approximately once every second day for a maximum of 4 sessions. Participants following stroke are typically discharged to subacute care or alternate care or discharged home on average 14 days post-stroke.
Intervention code [1] 330999 0
Treatment: Devices
Comparator / control treatment
Intermittent BP readings will be taken throughout the mobilisation session as per standard care practice using a standard digital blood pressure monitor/sphygmomanometer. This BP reading will be performed by a qualified physiotherapist as per standard practice when mobilising an acute stroke patient. These readings (likely to occur once the patient has been moved from lying down to sitting on the edge of the bed, or from sitting on the edge of the bed to standing up for example) will be conducted concurrently with the continuous BP prototype device in the same patient. Once an intermittent BP reading has been taken in a sustained posture (eg sitting on the edge of the bed), the patient will be assisted to move to the next most challenging position (eg from sitting on the edge of the bed to standing up) and the intermittent BP reading will be taken again. This is in line with standard practice when mobilising an acute stroke patient within a physiotherapy session for the first time.
Control group
Active

Outcomes
Primary outcome [1] 341353 0
Blood pressure (continuous)
Timepoint [1] 341353 0
The time points for data collection with the continuous BP prototype will be at study enrolment (commencing within first 14 days of admission), and then a further 3 sessions during the inpatient admission - note, the 4 (total) sessions may not necessarily be held on consecutive days. Each physiotherapy mobilisation session (described earlier) involving continuous BP monitoring with the prototype is likely to take a maximum of 30 minutes.
Primary outcome [2] 341355 0
Blood pressure (continuous)
Timepoint [2] 341355 0
The time points for data collection with the continuous BP prototype will be at study enrolment (commencing within first 14 days of admission), and then a further 3 sessions during the inpatient admission - note, the 4 (total) sessions may not necessarily be held on consecutive days. Each physiotherapy mobilisation session (described earlier) involving BP monitoring using the Finapres (concurrent with the prototype) is likely to take a maximum of 30 minutes.
Primary outcome [3] 341356 0
Blood pressure
Timepoint [3] 341356 0
The time points for data collection with the continuous BP prototype will be at study enrolment (commencing within first 14 days of admission), and then a further 3 sessions during the inpatient admission - note, the 4 (total) sessions may not necessarily be held on consecutive days. Each physiotherapy mobilisation session (described earlier) involving intermittent BP monitoring with standard method (concurrent with the Finapres and prototype) is likely to take a maximum of 30 minutes
Secondary outcome [1] 447272 0
Clinician rating of perceived stability of blood pressure during mobilisation
Timepoint [1] 447272 0
The time points for data collection using clinician judgement of BP stability during mobilisation will be at study enrolment (commencing within first 14 days of admission), and then a further 3 sessions during the inpatient admission - note, the 4 (total) sessions may not necessarily be held on consecutive days. Each physiotherapy mobilisation session (described earlier) is likely to take a maximum of 30 minutes. The clinician will judge BP stability from patient observation during each mobilisation task eg rolling over; lying down to sitting up on edge of bed; sitting on edge of bed etc.
Secondary outcome [2] 447273 0
Clinician rating of patient effort during mobilisation tasks
Timepoint [2] 447273 0
Video to be viewed following the initial session at study enrolment (commencing within first 14 days of admission), and then after the subsequent further 3 sessions during the inpatient admission. The viewing of the video will occur after the patient interaction (likely later that day); i.e. once the mobilisation session has been completed.

Eligibility
Key inclusion criteria
- within 14 days of diagnosis of acute stroke (infarct or haemorrhage)
- National Institutes of Health Stroke Scale (NIHSS) score equal to or greater than 16
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Sub Arachnoid Haemorrhage (SAH)
- Low levels of consciousness GCS <8
- Need for continuous ECG monitoring
- Medical interventions limiting mobility such as unclamped external ventricular drains
- Medically unstable and therefore deemed unsuitable for mobilisation
- Pre-stroke conditions significantly affecting mobility
- Cardiac devices including Permanent Pacemaker (PPM) devices

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2025
Actual
Date of last participant enrolment
Anticipated
9/03/2026
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC

Funding & Sponsors
Funding source category [1] 318906 0
Hospital
Name [1] 318906 0
St Vincent's Hospital, Melbourne
Country [1] 318906 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321369 0
None
Name [1] 321369 0
Address [1] 321369 0
Country [1] 321369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317522 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317522 0
Ethics committee country [1] 317522 0
Australia
Date submitted for ethics approval [1] 317522 0
06/05/2024
Approval date [1] 317522 0
15/04/2025
Ethics approval number [1] 317522 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141314 0
Prof Prue Morgan
Address 141314 0
Monash University, Department of Physiotherapy, 47-49 Moorooduc Highway, Frankston, VIC, 3199
Country 141314 0
Australia
Phone 141314 0
+61 03 9904 4826
Fax 141314 0
Email 141314 0
[email protected]
Contact person for public queries
Name 141315 0
Prue Morgan
Address 141315 0
Monash University, Department of Physiotherapy, 47-49 Moorooduc Highway, Frankston, VIC 3199
Country 141315 0
Australia
Phone 141315 0
+61 03 9904 4826
Fax 141315 0
Email 141315 0
[email protected]
Contact person for scientific queries
Name 141316 0
Prue Morgan
Address 141316 0
Monash University, Department of Physiotherapy, 47-49 Moorooduc Highway, Frankston VIC 3199
Country 141316 0
Australia
Phone 141316 0
+61 03 9904 4826
Fax 141316 0
Email 141316 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.