RecruitingNAINTERVENTIONAL

Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke

This research trial is open to people in the UK who have weakness on one side of their body (hemiparesis) after having a stroke. The main goal is to find out if using a special exercise bike, called FES-cycling, can improve heart and lung fitness better than regular cycling. FES-cycling uses gentle electrical pulses to help muscles work during cycling. Participants will be divided into two groups: one using the FES-cycling bike and another using a bike that looks similar but doesn't use electrical stimulation. Everyone in the study will also continue with their usual rehabilitation. The study lasts for 8 weeks of cycling, with checks before, straight after, and then 3 months later.

At a glance

Status

Recruiting

Phase

Sponsor

UGECAM Rhône-Alpes

Enrolment target

Start

17 Nov 2023

Estimated completion

01 Dec 2025

Hemiparesis;Poststroke/CVA

What is this study about?

This study is investigating a new way to help people who have weakness on one side of their body after a stroke, a condition called hemiparesis. The researchers want to see if using a special type of exercise bike called "FES-cycling" can improve a person's fitness more than traditional cycling. FES stands for Functional Electrical Stimulation, which means small, harmless electrical pulses are used to gently encourage the muscles in the legs to work while cycling. The aim is to make these weakened muscles stronger and help improve overall cardiovascular fitness, which is how well your heart and lungs work.

Participants in the study will be split into two groups by chance – like flipping a coin. One group will use the FES-cycling bike, where the electrical pulses help their leg muscles during exercise. The other group will use a regular exercise bike that looks identical but doesn't provide the electrical stimulation. This helps the researchers understand if the FES technology specifically makes a difference. Both groups will also continue with any regular rehabilitation they are already doing.

The study involves attending a neurological rehabilitation unit for 8 weeks. During this time, participants will cycle three times a week for 30 minutes. Researchers will check participants' fitness and other abilities at the beginning of the study, immediately after the 8 weeks, and then again three months later to see if any improvements are long-lasting. This research aims to find better ways to help people recover and regain their fitness after a stroke.

Key takeaways

Tests new cycling method for stroke recovery.
Uses gentle electrical pulses to help leg muscles.
Aims to improve heart and lung fitness.
Involves 8 weeks of cycling, three times a week.
You'll continue your normal rehabilitation too.
Helps researchers find best ways to help stroke survivors.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has experienced a stroke for the first time on one side of your brain, which has led to weakness on one side of your body. Your stroke must have happened between 3 months and 1 year ago. You should also be able to walk safely on your own and be able to understand instructions and complete tasks related to the study.

There are also some reasons why you wouldn't be able to join. If you have any history of other neurological problems or unstable heart conditions, you would not be eligible. Also, if you have severe stiffness (spasticity) in your ankle, knee, or hip muscles, or if you can't comfortably use an exercise bike, you wouldn't be suitable.

Finally, if you have a pacemaker or other medical devices that could be affected by electrical stimulation, or any other reason why electrical stimulation isn't safe for you, you won't be able to take part in this study.

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 an adult (18 or older)?
Did you have your first stroke between 3 months and 1 year ago?
Do you have weakness on one side of your body after your stroke?
Are you able to walk safely on your own?
Do you have good enough memory and understanding to follow instructions?
Do you *not* have a pacemaker or other electrical device that would be affected by stimulation?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in this study for about 5 months in total. This includes the preparation, 8 weeks of active participation, and a follow-up visit.

Here’s what taking part would involve: * **Initial Check-up:** Before the cycling begins, you'll have an assessment to see if you're suitable for the study and to measure your fitness and abilities. This will include tests like checking your walking and how well your heart and lungs work. * **Cycling Sessions:** For 8 weeks, you will attend the neurological rehabilitation unit three times a week. Each session will involve 30 minutes of active leg cycling. Depending on which group you are in, this will either be on an FES-cycling bike (where gentle electrical pulses help your leg muscles) or a standard exercise bike that looks the same but without electrical stimulation. * **Continuing Your Care:** Throughout the study, you will also continue with any standard rehabilitation programs or treatments that your doctors have already prescribed for you. * **Follow-up Visits:** You'll have another set of assessments immediately after the 8 weeks of cycling. Then, about 3 months after you finish the cycling, you'll have a final follow-up visit for assessments to see if any changes have lasted.

No specific medications are given as part of this study.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as improved cardiovascular fitness and potentially stronger leg muscles due to the exercise, especially if you are in the FES-cycling group. All participants will also receive regular exercise and monitoring. As with any exercise program, there's always a small risk of muscle soreness or fatigue. The electrical stimulation used in FES is generally mild and considered safe, but there's a very small chance of skin irritation. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

SMR Val Rosay
Verified postcode
Saint-Didier-au-Mont-d'Or, France· Recruiting

Common questions

What is FES-cycling?

FES-cycling uses gentle electrical pulses to help your leg muscles work while you cycle, aiming to make them stronger and improve your fitness.

How long will I have to cycle?

You will cycle for 30 minutes, three times a week, over an 8-week period. That's a total of 24 sessions.

Will I still get my usual therapy?

Yes, you will continue with your regular rehabilitation program alongside participating in this study.

Is the electrical stimulation painful?

The electrical stimulation is designed to be gentle and usually feels like a tingling sensation, not painful. Researchers will adjust it for your comfort.

What if I can't complete a cycling session?

The study team will work with you. If you feel unwell or cannot finish a session, you can stop, and it won't affect your ongoing care.

How to find out more

julie Di marco, MD

dr.jdimarco@gmail.com 01133472532161 Official trial record

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