Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-07-01
2026-07-01
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 - IPC device
IPC sleeves applied bilaterally according to manufacturer's instructions for standard VTE prophylaxis following ischaemic stroke.
Intermittent Pneumatic Compression
The IPC arm will use the Kendall SCD™ 700 Sequential Compression System, a routinely employed device for VTE prophylaxis in stroke patients. In this study, IPC sleeves will be applied bilaterally to the legs within 36 hours of stroke onset and operated according to the manufacturer's instructions. The intervention is distinguished by its cyclical external leg compression to enhance venous return, and it serves as the comparator to the geko® device for evaluating effects on cerebral blood flow and haemodynamics.
Group 2 - geko® device
The geko® device is a disposable, battery-powered neuromuscular electrostimulation device applied bilaterally to the peroneal nerve at the knee. It delivers low-frequency stimulation to activate the calf and foot muscle pumps, enhancing venous return and microcirculatory blood flow. Devices will be applied according to the manufacturer's instructions for VTE prophylaxis.
geko® T3
The geko® T3 device is a small, disposable, battery-powered neuromuscular electrostimulation device manufactured by Firstkind Ltd. In this study, the geko® will be applied bilaterally to the common peroneal nerve at the knee within 36 hours of stroke onset. It delivers transcutaneous electrical stimulation at 1 Hz, producing involuntary rhythmic foot dorsiflexion to activate the calf and foot muscle pumps. The intervention is distinguished from IPC by its mechanism of action (neuromuscular stimulation vs. external compression) and will be evaluated for its impact on cerebral haemodynamics, neurovascular coupling, and dynamic cerebral autoregulation during VTE prophylaxis.
Interventions
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Intermittent Pneumatic Compression
The IPC arm will use the Kendall SCD™ 700 Sequential Compression System, a routinely employed device for VTE prophylaxis in stroke patients. In this study, IPC sleeves will be applied bilaterally to the legs within 36 hours of stroke onset and operated according to the manufacturer's instructions. The intervention is distinguished by its cyclical external leg compression to enhance venous return, and it serves as the comparator to the geko® device for evaluating effects on cerebral blood flow and haemodynamics.
geko® T3
The geko® T3 device is a small, disposable, battery-powered neuromuscular electrostimulation device manufactured by Firstkind Ltd. In this study, the geko® will be applied bilaterally to the common peroneal nerve at the knee within 36 hours of stroke onset. It delivers transcutaneous electrical stimulation at 1 Hz, producing involuntary rhythmic foot dorsiflexion to activate the calf and foot muscle pumps. The intervention is distinguished from IPC by its mechanism of action (neuromuscular stimulation vs. external compression) and will be evaluated for its impact on cerebral haemodynamics, neurovascular coupling, and dynamic cerebral autoregulation during VTE prophylaxis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
3. Within 36 hours of symptom onset.
4. Unable to stand or mobilise without assistance.
5. No intracerebral haemorrhage as ruled out by computerised tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
Exclusion Criteria
2. Absence of a transient ischaemic attack (TIA).
3. Clinically apparent deep vein thrombosis at screening
4. Patient is expected to require palliative care within 14 days
5. No response to the geko® device i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
6. Contraindications for the use of the geko™ device
* Allergy to hydrogel constituents
7. Contraindications to IPC
* Severe peripheral vascular disease
* Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
* Severe oedema
* Leg deformities making appropriate fitting impossible
* Symptomatic congestive cardiac failure of NYHA class IV (symptoms of heart failure at rest, any physical activity causing further discomfort).
8. Single or double leg amputations.
9. Participation in any other clinical trial
10. Patients must not have a current coronavirus (COVID-19) infection
18 Years
ALL
No
Sponsors
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Innovate UK
OTHER_GOV
Firstkind Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Kausik Chatterjee
Role: STUDY_DIRECTOR
COUNTESS OF CHESTER HOSPITAL NHS FOUNDATION TRUST
Locations
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Countess of Chester Hospital
Chester, Cheshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10038715
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ISS-BBF-002
Identifier Type: -
Identifier Source: org_study_id
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