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RECRUITING Not applicable ClinicalTrials.gov

Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults

Sponsor: Joey Porter • ClinicalTrials.gov ID: NCT07666828

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Medic (Device)
    The 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 (Device)
    Programme 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 (Device)
    Personalised 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.

Eligibility criteria

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.

Conditions

Healthy

Locations

  • The Lightbox — Bracknell, Berkshire, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record