Status:
RECRUITING
The RETRAIN Trial Phase 2
Lead Sponsor:
Firstkind Ltd
Collaborating Sponsors:
Innovate UK
Conditions:
Ischaemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
This study is a randomised trial at a single centre, comparing brain blood flow and activity patterns when two standard treatments for preventing blood clots (VTE) are used following a stroke. Who Ca...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
- Contraindications for the use of the geko™ device
- Allergy to hydrogel constituents
- 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).
- Single or double leg amputations.
- Participation in any other clinical trial
- Patients must not have a current coronavirus (COVID-19) infection
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07197996
Start Date
July 1 2025
End Date
July 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
Countess of Chester Hospital
Chester, Cheshire, United Kingdom, CH2 1UL