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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Countess of Chester Hospital
RECRUITING
Chester
Contact Information
Primary
Pramodh Hettiarachchi, MRCP
phettiarachchi@nhs.net
+44 1244 365000
Backup
Kausik Chatterjee, FRCP, MD
kausikchatterjee@nhs.net
+44 1244362618
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 80
Treatments
Experimental: Group 1 - IPC device
IPC sleeves applied bilaterally according to manufacturer's instructions for standard VTE prophylaxis following ischaemic stroke.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Innovate UK
Leads: Firstkind Ltd

This content was sourced from clinicaltrials.gov

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