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Monitoring blood pressure continuously whilst mobilising people after severe stroke

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000502437
Enrollment
10
Registered
2025-05-22
Start date
2025-06-09
Completion date
2026-03-09
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with severe acute stroke may experience blood pressure (BP) fluctuation outside targeted range when mobilising. Intermittent BP monitoring may not detect change in a timely manner. This pilot study aims to explore the value of a continuous BP prototype to provide real time BP information matched to patient movement activities during usual care (mobilisation). BP prototype data from 10 participants will be compared to intermittent BP readings, and clinician judgement of BP stability and patient effort. Findings may guide optimal clinical practice in acute mobilisation following severe stroke.

Interventions

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

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026