Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults
This study is looking at a device called Revitive, which uses gentle electrical pulses through a foot pad to help improve blood flow in your legs. Researchers are testing two new ways (called P1 and PM7) this device can deliver these pulses, to see if they are better at increasing blood flow than the current setting (called Medic). They also want to know how comfortable these new settings are to use. About 24 healthy adults in the UK will take part. Participants will try all three settings, have their blood flow measured, and share their comfort levels. This helps improve devices that can help people with their circulation.
At a glance
What is this study about?
This research study is about a device called Revitive, which uses gentle electrical pulses to stimulate your leg muscles through a foot pad. The idea is that this stimulation can help improve blood flow in your lower legs. The main goal of this study is to compare the current settings (called 'Medic') with two new experimental settings (called 'P1' and 'PM7'). Researchers want to find out if these new settings are better at increasing blood flow in healthy adults.
They're also interested in how comfortable people find each setting. By measuring blood flow and asking about comfort, the researchers hope to understand if these new settings could offer even better benefits for circulation. This study is important because improving blood flow in the legs can be helpful for many people, and finding the most effective and comfortable ways to do this is a key step.
This study uses a special version of the Revitive device that allows for these new settings to be tested. It doesn't change how the device works generally, its materials, or its safety features, but simply lets researchers try out different stimulation patterns. The information gathered from healthy adults in this study will help to improve how these devices work in the future.
Key takeaways
- This study is testing different settings of a Revitive foot pad device to improve leg blood flow.
- It aims to find out if new settings (P1, PM7) are better than the current one (Medic) for increasing circulation.
- Researchers will also check how comfortable people find each setting.
- About 24 healthy adults will take part, visiting a research centre four times.
- Measurements of blood flow and muscle oxygen will be taken during device use.
- Your comfort and experience will be assessed through questionnaires.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older and be able to understand and speak English. This is because you'll need to give your permission to take part and understand the instructions.
There are certain health conditions that would mean you couldn't take part. For example, if you have a pacemaker or any other electronic device implanted in your body, or if you are pregnant or planning to become pregnant. You also can't join if you have a blood clot in your leg (DVT), certain heart problems, nerve damage from diabetes, or specific muscle, bone, or skin issues in your feet or legs.
If you have a serious illness, certain brain conditions like epilepsy, or diseases affecting your blood vessels, this study would not be suitable for you. This is to ensure the safety of all participants.
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 old or older?
- Do you speak and understand English?
- Are you generally healthy, without any serious ongoing medical conditions?
- Do you NOT have an electronic implanted device like a pacemaker?
- Are you NOT pregnant or trying to become pregnant?
- Do you NOT have conditions like DVT, severe heart problems, diabetes with nerve damage, or certain skin/muscle issues in your legs?
What does participation involve?
If you decide to take part, you will visit a single research centre four times. The first visit will be a chance for you to get familiar with the study and the device. After that, you'll have three testing visits, with at least 12 hours and up to 7 days between each one.
During each of these three testing visits, you will use the Revitive foot pad device for 30 minutes. You will try a different setting (Medic, P1, or PM7) each time, and the order will be chosen randomly. While you are using the device, researchers will take measurements of your blood flow and how much oxygen is in your leg muscles.
After each session, you'll also be asked to fill out some questionnaires about how comfortable you found the device and your overall experience. The total duration of your involvement will depend on how you space out your visits, but it will involve these four appointments and the measurements taken during them.
Potential risks and benefits
Locations (1)
- The LightboxVerified postcodeBracknell, United Kingdom· Recruiting
Common questions
What is 'Neuromuscular Electrical Stimulation' (NMES)?
It's a way of using gentle electrical pulses to make your muscles contract. When muscles contract, it helps to pump blood, improving circulation.
What is a 'foot pad programme'?
This refers to the different settings or patterns of electrical pulses that the Revitive foot pad device can deliver. This study is comparing three different patterns.
Will I know which setting I'm using?
No, this is a 'double-blind' study, meaning neither you nor the research team will know which specific setting (Medic, P1, or PM7) you are trying during each visit. This helps keep the results fair.
Are there any side effects from the electrical stimulation?
Most people find the stimulation comfortable, but you might feel a tingling sensation or mild muscle contraction. Your comfort will be checked throughout the study.
Do I have to do anything special before or after the study visits?
The study team will give you specific instructions, but generally, you'll just need to attend your appointments and complete the questionnaires.
How to find out more
Joey O Porter, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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