An interventional study of Medic and P1 in Healthy, sponsored by Joey Porter. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Joey Porter · Not applicable, Interventional, and Basic science
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:
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:
The TRI-HEX study is a single-centre, randomised, double-blind, crossover clinical investigation evaluating the haemodynamic performance of three neuromuscular electrical stimulation (NMES) foot pad programs delivered through an investigational version of the Revitive device platform. The study will recruit 24 healthy adult participants in the United Kingdom.
Revitive is a non-invasive NMES device designed to improve blood circulation in the lower limbs during use. The investigational device (14065AT) is derived from the commercially available Revitive Medic Coach device and incorporates firmware modifications that enable delivery of additional predefined stimulation programmes for research purposes. The modification does not alter the device's intended purpose, mode of action, hardware, materials, or electrical output limits.
The study will evaluate three NMES programmes:
Medic - the currently marketed Revitive NMES foot pad programme. Programme 1 (P1) - a newly developed stimulation program designed to minimise muscle adaptation during use.
Personalised Medic v7 (PM7) - a stimulation programme that incorporates a personalised modulation function intended to optimise haemodynamic response.
The primary objective is to compare the effect of P1 and PM7 against the Medic programme on lower limb blood volume flow during a single 30-minute NMES session. Blood volume flow will be measured at the superficial femoral artery using Doppler ultrasound.
Secondary objectives are to compare:
User discomfort during stimulation using a visual analogue scale (VAS). Changes in muscle oxygen saturation (SmO2) measured by near-infrared spectroscopy (NIRS).
Exploratory objectives include assessment of:
Time averaged mean velocity (TAMV) at the superficial femoral artery. Changes in superficial femoral artery diameter. Post-stimulation recovery of muscle oxygenation. Relationships between haemodynamic outcomes and device-recorded accelerometry data.
Relationships between haemodynamic outcomes and skin hydration measurements.
The study uses a double-blinded crossover design, where each participant receives all three interventions in a randomised sequence and both participants and the Chief Investigator remain blinded to intervention allocation. Randomisation is performed using a predefined crossover allocation schedule, and an independent unblinded assessor is responsible for treatment sequence management.
Participants will attend four visits:
Visit 1: eligibility confirmation, informed consent, device familiarisation, collection of baseline demographic and lifestyle information, and a motion analysis baseline assessment.
Visits 2-4: completion of one 30-minute NMES session per visit using one of the three study programmes, with a washout period of 12 hours to 7 days between sessions.
During each testing visit, participants will undergo a 10-minute baseline measurement period, followed by a 30-minute NMES session and 8-minute post-stimulation monitoring. Doppler ultrasound and NIRS measurements will be collected throughout the assessment period. Participants will also complete questionnaires regarding discomfort and device experience.
The study is designed as an exploratory clinical investigation to generate haemodynamic performance data on newly developed NMES stimulation programmes under controlled conditions. Results will be used to assess differences in haemodynamic performance between the investigational programmes and to support future product development and evidence generation activities.
This is the only study on the registry with Joey Porter as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive the Medic programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.
Device: Medic
Participants receive the Programme 1 (P1) delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.
Device: P1
Participants receive the PM7 programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.
Device: PM7
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.
Also known as: Medic programme
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.
Also known as: Programme 1
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.
Also known as: Personalised Medic Programme v7
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.
Time frame: Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.
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.
Time frame: Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.
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.
Time frame: During the 30-minute stimulation session
Plan to share: No — Individual participant data (IPD) will not be shared because this is an early feasibility, manufacturer-sponsored exploratory investigation with a small sample size (n=24). Due to the limited study population and the potential risk of participant re-identification, de-identified participant-level datasets will not be made publicly available. Aggregate study results will be reported through ClinicalTrials.gov and any resulting scientific publications.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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