Actively Recruiting
MonitoRing the Effect of Intermittent Pneumatic Compression and TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve Using the Geko® Device on Cerebral Haemodynamics in Patients With Ischaemic Strokes (The RETRAIN Trial Phase 2)
Led by Firstkind Ltd · Updated on 2025-09-30
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
F
Firstkind Ltd
Lead Sponsor
I
Innovate UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ischaemic strokes occur due to a disruption in the brain's blood supply and are a leading cause of death and disability. This randomised study aims to compare the effects of two standard devices, the geko® neuromuscular electrostimulation device and the intermittent pneumatic compression (IPC) device, on brain blood flow in patients who recently had an ischaemic stroke. The study focuses on the hyperacute phase within 36 hours of stroke onset and evaluates cerebral blood flow and oxygen delivery. Participants will be randomly assigned to use either the IPC device, which applies cyclic external pressure to the legs to promote blood flow, or the geko® device, which stimulates nerves in the lower leg to induce muscle contractions that enhance circulation. Both devices are used as part of routine care to prevent blood clots. The devices will be applied bilaterally following manufacturers' instructions during the study period. During the study, brain blood flow will be measured using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG) while patients are sitting upright in bed. Assessments include periods with the device off and on, conducted twice daily over two days. Vital signs such as blood pressure, ECG, temperature, and oxygen levels will be monitored continuously. No follow-up is required after completing these assessments.
CONDITIONS
Brief Title
The RETRAIN Trial Phase 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 CT or MRI scan
You will not qualify if you...
- Unable to provide consent or have a personal or nominated consultee provide consent
- Diagnosis of transient ischaemic attack (TIA) instead of stroke
- Clinically apparent deep vein thrombosis at screening
- Expected to require palliative care within 14 days
- No response to the geko® device at maximum tolerable setting
- Allergy to hydrogel in the geko® device
- Severe peripheral vascular disease
- Large leg ulcers requiring extensive bandaging
- Severe oedema
- Leg deformities preventing device fitting
- Symptomatic congestive heart failure of NYHA class IV
- Single or double leg amputations
- Participation in any other clinical trial
- Current coronavirus (COVID-19) infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 36 hours before treatment start
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 2 days
Participants receive one of two standard devices for preventing blood clots after stroke. The device is applied within 36 hours of stroke onset and used during the study period.
Twice daily assessments for 2 consecutive days
Trial Site Locations
Total: 1 location
1
Countess of Chester Hospital
Chester, Cheshire, United Kingdom, CH2 1UL
Actively Recruiting
Research Team
P
Pramodh Hettiarachchi, MRCP
K
Kausik Chatterjee, FRCP, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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