The RETRAIN Trial Phase 2

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirstkind Ltd

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intermittent Pneumatic Compression
  • geko® T3

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Firstkind Ltd

Lead sponsor

Innovate UK

Collaborator