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.
Healthy
Age 18 or over
Ability to communicate in English and provide informed consent
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)
Crossover
Medic
DeviceThe Medic programme is a currently marketed neuromuscular electrical stimulation (NMES) foot pad programme. It delivers electrical stimulation through the soles of the feet, via a commercially available NMES medical device, to induce lower limb muscle contractions and improve blood circulation during use.
P1
DeviceProgramme 1 (P1) is an investigational NMES foot pad programme that incorporates a modified stimulation pattern designed to reduce muscle adaptation during a 30-minute stimulation session while maintaining the same intended purpose and mode of action as the marketed programme.
PM7
DevicePersonalised Medic v7 (PM7) is an investigational NMES foot pad programme that incorporates a modulation function intended to optimise the haemodynamic response during stimulation while maintaining the same intended purpose and mode of action as the marketed programme.
Change in blood volume flow at the superficial femoral artery (SFA)
Change in blood volume flow from baseline at the superficial femoral artery during a single 30-minute neuromuscular electrical stimulation (NMES) programme. Blood volume flow will be measured using Doppler ultrasound and compared between the Medic, P1, and PM7 NMES programmes.
Change in muscle oxygen saturation (SmO2) at the medial gastrocnemius
Change in muscle oxygen saturation from baseline at the medial head of the gastrocnemius during a single 30-minute NMES programme. SmO2 will be measured using Near-Infrared Spectroscopy (NIRS) and compared between the Medic, P1, and PM7 programmes.
Discomfort during NMES stimulation
Participant-reported discomfort assessed using an 11-point Visual Analogue Scale (VAS, 0-10, higher scores indicate greater discomfort) during a single 30-minute NMES session. Scores will be compared between the Medic, P1, and PM7 programmes. Participants will report their VAS score immediately after completion of the test period and will refer to their experience over the whole 30-minute programme.
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Joey Porter
Lead sponsor
Actegy Ltd.
Sponsor institution
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