Actively Recruiting
The RETRAIN Trial Phase 2
Led by Firstkind Ltd · Updated on 2025-09-30
80
Participants Needed
1
Research Sites
52 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, 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).
CONDITIONS
Official Title
The RETRAIN Trial Phase 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of ischaemic stroke confirmed by a stroke physician
- Within 36 hours of stroke symptom onset
- Unable to stand or mobilise without assistance
- No bleeding in the brain confirmed by CT or MRI scan
You will not qualify if you...
- Unable to provide consent or have a Personal or Nominated Consultee
- Diagnosis of transient ischaemic attack (TIA) only
- Clinically apparent deep vein thrombosis at screening
- Expected need for palliative care within 14 days
- No response to the geko4 device at maximum tolerable setting
- Allergy to hydrogel components (contraindication for geko4 device)
- Severe peripheral vascular disease (contraindication for IPC)
- Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings allowed)
- Severe oedema (contraindication for IPC)
- Leg deformities preventing proper fitting of devices
- Symptomatic congestive heart failure classified as NYHA class IV
- Single or double leg amputations
- Participation in another clinical trial
- Current coronavirus (COVID-19) infection
AI-Screening
AI-Powered Screening
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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
CONTACT
K
Kausik Chatterjee, FRCP, MD
CONTACT
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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