Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemod… (NCT07666828) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults
24 participantsStarted 2026-07-06
Plain-language summary
The goal of this clinical investigation is to evaluate the performance of three neuromuscular electrical stimulation (NMES) foot pad programmes in healthy adults. It will also learn about how well the NMES programmes are tolerated.
The main questions it aims to answer are:
* Do two newly-developed NMES programmes ('P1' and 'PM7') increase lower limb blood flow more than the existing 'Medic' NMES programme during use?
* How do the programmes compare in terms of user discomfort and muscle oxygenation during use?
Researchers will compare the P1 and PM7 programmes with the existing Medic programme to determine whether the new programmes produce greater improvements in lower limb haemodynamics during device use.
Participants will:
* Attend four study visits at a single research site.
* Complete 1 familiarisation visit and 3 testing visits, with 12 hours to 7 days between visits.
* Use all three NMES programmes once in a randomised order.
* Receive 30 minutes of NMES during each testing visit.
* Undergo blood flow and muscle oxygenation measurements during each test.
* Complete questionnaires about discomfort and their experience using the device.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy
* Age 18 or over
* Ability to communicate in English and provide informed consent
Exclusion Criteria:
* Lack of capacity to provide informed consent
* Electronic implanted device (e.g. cardiac pacemaker)
* Pregnancy or intending to become pregnant during the study period
* Currently being treated for or have symptoms of an existing deep vein thrombosis (DVT)
* Diagnosis of vascular disease or disorder
* Terminal illness
* Neurological disorders (e.g. epilepsy)
* Musculoskeletal injury/disorders (e.g. recent injury or surgery)
* Skin conditions (e.g. eczema or open wounds near plantar surface of the foot)
* Cardiovascular conditions (e.g. arrhythmia or uncontrolled hypertension)
* Diabetes mellitus with neuropathy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in blood volume flow at the superficial femoral artery (SFA)
Timeframe: Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.