Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults (TRI-HEX)

June 25, 2026 updated by: Joey Porter

Evaluation of Lower Limb Haemodynamics Using Three (TRI) Neuromuscular Electrical Stimulation Foot Pad Programmes: A Crossover (X) Randomised Controlled Study in Healthy (HE) Adults

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medic
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
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.
Other Names:
  • Medic programme
Experimental: P1
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
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.
Other Names:
  • Programme 1
Experimental: PM7
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
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.
Other Names:
  • Personalised Medic Programme v7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood volume flow at the superficial femoral artery (SFA)
Time Frame: Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.
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.
Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle oxygen saturation (SmO2) at the medial gastrocnemius
Time Frame: Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.
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.
Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.
Discomfort during NMES stimulation
Time Frame: During the 30-minute stimulation session
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.
During the 30-minute stimulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joey Porter

Investigators

  • Principal Investigator: Joey Porter, Actegy Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 6, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 26/WM/0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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