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A study to look at using electrical stimulation for leg weakness early after stroke

This study investigates if a gentle electrical treatment can help people with leg weakness early after a stroke. Stroke can cause weakness, making walking difficult and leading to muscle wasting. Physiotherapists sometimes use electrical stimulation, which is safe and painless, to make muscles contract. This research wants to see if this treatment can stop leg muscles from wasting, potentially helping people walk and do daily activities sooner. This is a small, initial study to make sure the treatment and study methods are suitable before a larger trial. People aged 18 and over who have had a stroke within the last two weeks and are well enough can take part.

At a glance

Status
Recruiting
Sponsor
University Hospitals Dorset NHS Foundation Trust
Enrolment target
60
Start
01 Oct 2025
Estimated completion
30 Sep 2026

What is this study about?

When someone has a stroke, it can sometimes cause weakness on one side of their body, especially in their legs. This can make it very hard or even impossible for them to walk without help. Over time, these weakened leg muscles can get smaller, which is called muscle wasting. This makes it even harder to regain strength and independence.

Doctors and physiotherapists sometimes use a treatment called electrical stimulation. This involves placing sticky pads on the skin, which deliver gentle electrical currents to make the muscles contract. It's generally a safe and painless procedure. This study wants to find out if using this electrical stimulation early on, soon after a stroke, can stop the leg muscles from wasting away. If it can, this treatment might help people get back on their feet and do their everyday activities much sooner.

This particular study is a smaller, first step to see if the idea works as planned. Researchers need to check a few things: if the study design is good, if people who've had a stroke are interested in this treatment and find it helpful, and if the way the treatment is given and measured is acceptable and easy for participants. The results of this small study will help decide if a larger study should be done in the future.

Key takeaways

  • A study looking at electrical stimulation for leg weakness after stroke.
  • Aims to prevent muscle loss and help people walk sooner.
  • Small, initial study to test if the treatment and study design work.
  • Involves 12 weeks of potential electrical stimulation, mostly at home.
  • Total participation is for six months, with four check-up visits.
  • No major risks; skin irritation is rare.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and have had a stroke within the last two weeks. You should also be well enough to safely participate in rehabilitation activities and the study's treatments. Your stroke should have caused some weakness in your leg, making it difficult for you to walk or move around on your own, even with a walking aid.

There are also some reasons why you might not be able to join. For example, if you couldn't walk on your own before your stroke, or if you have certain other medical conditions like a recent blood clot (DVT), uncontrolled epilepsy, or issues with your skin where the sticky pads would go. If you are pregnant or have had previous strokes with ongoing leg weakness, you also wouldn't be able to join this study. The research team will check all these details with you carefully.

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.

  1. Are you 18 years old or older?
  2. Did you have a stroke within the last two weeks?
  3. Are you well enough to take part in rehabilitation?
  4. Is your leg weak after the stroke, making it hard to walk?
  5. Could you walk by yourself before your stroke?
  6. Do you have good skin where the sticky pads would go?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be involved for about six months. You'll be randomly assigned to one of two groups: either you'll receive your usual care, or you’ll receive your usual care plus electrical stimulation for your affected leg muscles. The electrical stimulation therapy would happen three times a week for 12 weeks. If you're in the electrical stimulation group, you'll be shown how to use the device at home and asked to keep a diary of when you use it.

Throughout the six months, you'll have four visits with the research team. During these visits, they will check your physical abilities, such as how well you can walk, your grip strength, and your leg strength. You will also be asked to fill out questionnaires about your quality of life and any hospital services you've used. Some participants might also be invited for a short interview to talk about their experiences in the study.

Potential risks and benefits

Taking part in this study might help you get back to walking sooner after your stroke if the electrical stimulation treatment proves effective. However, we can't guarantee that you will personally feel a direct benefit. The information we gather will definitely help us better understand how to treat leg muscle weakness for future stroke patients. There are no major or serious risks expected from taking part in this study. Rarely, some people might experience a mild skin irritation from the sticky pads used for electrical stimulation. You might also find some of the physical tests a bit tiring, but the research team will do their best to make you comfortable and accommodate your needs. Remember, you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospitals Dorset NHS Foundation Trust
    City only
    Poole, United Kingdom

Common questions

What is electrical stimulation?

It's a treatment where sticky pads deliver gentle electrical currents to your muscles to help them contract. It's generally safe and painless.

How long will I be in the study?

Participation in the study will last for about six months, with electrical stimulation being used for 12 weeks of that time if you're in that group.

Will I have to go to the hospital often?

You will have four visits with the research team over the six months. Electrical stimulation, if you receive it, is mostly done at home.

What if I don't feel better?

While we hope the treatment helps, we can't promise a direct benefit for you. Your participation will still provide valuable information for future patients.

Can I stop taking part if I change my mind?

Yes, you are free to leave the study at any time without needing to give a reason.

How to find out more

Katey Collins

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

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