RecruitingNAINTERVENTIONAL

The RETRAIN Trial Phase 2

The RETRAIN study is looking into how two common medical devices, the geko® and IPC, affect the brain in people who have recently had a stroke. A stroke happens when the blood supply to the brain is cut off, which can cause serious problems. These devices are usually used to stop blood clots forming, but this study wants to see if they can also help improve blood flow and oxygen to the brain during the critical first 36 hours after a stroke. Researchers will measure brain blood flow and activity in stroke patients using either the geko® device, which stimulates a nerve in the leg to boost circulation, or an IPC device, which uses inflatable sleeves on the leg to gently squeeze and release, mimicking muscle action. This research could help us understand better ways to support recovery after a stroke.

At a glance

Status

Recruiting

Phase

Sponsor

Firstkind Ltd

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Jul 2026

Ischaemic Stroke

What is this study about?

When someone has an ischaemic stroke, it means part of their brain isn't getting enough blood, and therefore not enough oxygen. This can lead to serious and lasting health problems. This study, called The RETRAIN Trial, is trying to find out if two types of widely used medical devices can help improve blood flow and oxygen levels in the brain in the very early hours after a stroke.

The first device is called geko®. It's a small device that sticks to your leg and gently stimulates a nerve, making your leg muscles contract. This helps to pump blood around your body, including towards your brain. The second device is an Intermittent Pneumatic Compression (IPC) device. This involves sleeves wrapped around your legs that gently inflate and deflate with air, feeling a bit like a squeeze and release. This action also helps to boost blood circulation.

Both the geko® and IPC devices are routinely used in hospitals to prevent blood clots, especially in people who can't move around much. However, this study wants to specifically measure if they can also help the brain directly after a stroke by increasing blood flow. Researchers will be carefully monitoring brain activity and blood circulation using special equipment to see if these devices make a difference. The aim is to understand if these established treatments could offer an additional benefit for stroke recovery.

Key takeaways

The study investigates common devices (geko®, IPC) for stroke recovery.
It aims to understand their effect on brain blood flow after a stroke.
Participation involves short brain measurements over two days.
The devices are standard care for preventing blood clots.
Your care will not be affected if you choose not to participate.
This research could help improve future stroke treatments.

Who may be eligible?

To join this study, you need to be at least 18 years old and have recently had a type of stroke called an ischaemic stroke. This means your stroke was caused by a clot blocking blood flow to your brain, not by bleeding in the brain. You would need to have had your stroke symptoms start within the last 36 hours and be unable to stand or move around on your own. Doctors will have confirmed your stroke with a CT or MRI scan, making sure there's no bleeding.

There are some reasons why you might not be able to take part. For example, if you can't give your consent to join, or if you have certain health conditions like severe heart failure, blood clots that have already formed in your leg, or very poor circulation in your legs. Also, if you have allergies to certain materials in the devices, or if you've recently had COVID-19, you wouldn't be able to join. The study also needs to make sure the geko® device works properly on your leg (by checking for foot movement) and that you don't require end-of-life care in the next two weeks.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Did you have an ischaemic stroke (not bleeding in the brain)?
Did your stroke symptoms start less than 36 hours ago?
Can you not stand or walk on your own right now?
Do you not have severe heart failure or leg circulation problems?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be randomly assigned to one of two groups: one group will use the IPC device, and the other will use the geko® device. Both devices are part of normal care to prevent blood clots. You'll be asked to sit upright in bed for assessments. During these times, your brain blood flow will be measured using special sensors placed on your head, which don't involve needles or discomfort. Your blood pressure, heart rate, temperature, and oxygen levels will also be continuously checked.

These measurements will take place twice a day for two days. Each measurement session will involve 5 minutes with the device switched off, followed by 5 minutes with it switched on. This means the actual measurement part for each session is 10 minutes, but with preparation, it will take about 40 minutes per day, across two days (80 minutes total). There are no further appointments or follow-up needed after these two days of assessments. You will not be given any new medications specifically for this study.

Potential risks and benefits

Taking part in this study may or may not directly benefit you. The devices used in this study (geko® and IPC) are already standard treatments used in hospitals to prevent blood clots. The main benefit is that your care will be closely monitored, and your participation will help doctors learn more about how stroke affects the brain and how these devices might help. This knowledge could improve care for future stroke patients. Risks associated with the devices are generally low but can include skin irritation or, in rare cases, a worsening of swelling in the leg. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Countess of Chester Hospital
Verified postcode
Chester, United Kingdom· Recruiting

Common questions

What is an ischaemic stroke?

It's a type of stroke caused by a blood clot blocking blood flow to part of the brain, leading to brain damage.

What do the geko® and IPC devices do?

Both devices help improve blood circulation in your legs, which is important for preventing blood clots. The geko® stimulates a nerve, and IPC uses inflatable cuffs.

Will I get a new treatment in this study?

No, both the geko® and IPC devices are already standard treatments used in hospitals to prevent blood clots after a stroke. This study is just looking at how they affect brain blood flow.

How long will I be in the study?

The study assessments will take place over two days, with two short measurement sessions each day. There is no follow-up after that.

What measurements will be taken?

Doctors will measure blood flow and electrical activity in your brain using special sensors. They'll also check your blood pressure, heart rate, temperature, and oxygen levels.

How to find out more

Pramodh Hettiarachchi, MRCP

phettiarachchi@nhs.net +44 1244 365000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.