At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Intermittent Pneumatic Compression (device), geko® T3 (device)
- How long the study runs
- Study runs about 10 months (dates as stated)
- About the drug or intervention
- Intermittent Pneumatic Compression — device: The IPC arm will use the Kendall SCD™ 700 Sequential Compression System, a routinely employed device for VTE prophylaxis in stroke patients. · geko® T3 — device: The geko® T3 device is a small, disposable, battery-powered neuromuscular electrostimulation device manufactured by Firstkind Ltd.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 53
- Started
- 2025-07-01
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for ischaemic stroke
- • NA - 53 participants
- • Ischaemic strokes, caused by a disruption in the brain's blood supply, are the second leading cause of death and disability in the United Kingdom
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ischaemic stroke
Where?
- • Chester - Countess of Chester Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Ischaemic strokes, caused by a disruption in the brain's blood supply, are the second leading cause of death and disability in the United Kingdom. This single-center prospective randomised study aims to measure cerebral blood flow and oxygen delivery in patients who have recently suffered an ischaemic stroke and are using either the geko® neuromuscular electrostimulation device or an intermittent pneumatic compression (IPC) device as part of their routine clinical care. The geko® device stimulates a nerve in the lower leg, inducing muscle contractions that enhance blood circulation. The IPC device applies controlled external pressure through compressed air and a pump, cyclically inflating and deflating chambers in a sleeve worn on the leg. This mimics the action of calf muscles to promote blood flow. The primary objective of this study is to assess the effect of the geko® and IPC devices on cerebral blood flow in stroke patients, specifically during the hyperacute phase (within 36 hours) following an ischaemic stroke. Both devices will be used as part of standard care for VTE prevention. Cerebral blood flow will be measured using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG).
More detail
This study is a randomised trial at a single centre, comparing brain blood flow and activity patterns when two standard treatments for preventing blood clots (VTE) are used following a stroke. Who Can Take Part? Patients will be identified for the study as part of their routine hospital care when they arrive at hospital through the emergency department. To take part they must: 1. Be 18 years or older 2. Have had an ischaemic stroke confirmed by a stroke doctor 3. Be within 36 hours of stroke symptom onset 4. Be unable to stand or move around 5. Have had a CT or MRI scan confirming no bleeding in the brain What Will Happen? After confirming eligibility and once consent is given, 80 participants will be randomly assigned to one of two groups during the study period: Group 1 - IPC device Group 2 - geko® device Both devices are standard treatments for preventing blood clots. Study Assessments Brain blood flow will be measured while participants are sitting upright in bed. Each session will include: 5 minutes with the device switched off 5 minutes with the device switched on These assessments will take place twice a day for two days (a total of 40 minutes) with a pre-assessment preparation (a total of 80 minutes over the two days). Blood pressure, ECG, temperature, and oxygen levels will be continuously monitored. No follow-up is required after the study.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Adult over 18
- ✓Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
- ✓Within 36 hours of symptom onset.
- ✓Unable to stand or mobilise without assistance.
- ✓No intracerebral haemorrhage as ruled out by computerised tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
Who cannot take part
- ✗Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee.
- ✗Absence of a transient ischaemic attack (TIA).
- ✗Clinically apparent deep vein thrombosis at screening
- ✗Patient is expected to require palliative care within 14 days
- ✗No response to the geko® device i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion)...
See the full criteria
Where Is This Study? (1 UK site)
Countess of Chester Hospital
Chester CH2 1UL, United Kingdom