HealthyTRI-HEXNCT07666828
Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults
A study testing Medic, P1 and PM7 in people with Healthy, run by Joey Porter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Medic, P1 and PM7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Age 18 or over
- Ability to communicate in English and provide informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Lightbox
Bracknell, Berkshire, RG12 8FB
Joey O Porter, MSc, +44 7415605740, joseph.porter@actegy.com
Roseanna Penny, +44 7310817749, roseanna.penny@actegy.com
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Medic, P1, PM7
- Keywords
- Neuromuscular Electrical Stimulation, Healthy, Blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedicDevice
Also called Medic programme
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.
P1Device
Also called Programme 1
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.
PM7Device
Also called Personalised Medic Programme v7
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.
| Study group | Role | What they receive |
|---|---|---|
| Medic | Active comparator | Participants receive the Medic programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session. Receives: Device: Medic |
| P1 | Experimental | Participants receive the Programme 1 (P1) delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session. Receives: Device: P1 |
| PM7 | Experimental | Participants receive the PM7 programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session. Receives: Device: PM7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout a 10-minute baseline, the 30-minute stimulation session and 8-minute post-stimulation period.
Secondary outcomes (2)
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.
Measured: 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.
Measured: During the 30-minute stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start22 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joey Porter
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Joey Porter, Actegy Ltd.
- Investigators
- Joey O Porter, Principal investigator, Actegy Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666828
- Sponsor's protocol ID
- 26/WM/0029
- Acronym
- TRI-HEX
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kumaran B, Targett D, Watson T. Benefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial. BMC Geriatr. 2024 Aug 14;24(1):683. doi: 10.1186/s12877-024-05271-z.
PubMed 39143586Varatharajan L, Williams K, Moore H, Davies AH. The effect of footplate neuromuscular electrical stimulation on venous and arterial haemodynamics. Phlebology. 2015 Oct;30(9):648-50. doi: 10.1177/0268355514542682. Epub 2014 Jul 4.
PubMed 24997200
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lower Limb Haemodynamics Using Three (TRI) Neuromuscular Electrical Stimulation Foot Pad Programmes: A Crossover (X) Randomised Controlled Study in Healthy (HE) Adults
- ClinicalTrials.gov ID
- NCT07666828
- Acronym / sponsor ID
- TRI-HEX / 26/WM/0029
- Conditions
- Healthy
- Keywords
- Neuromuscular Electrical Stimulation, Healthy, Blood flow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Joey PorterIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medic | Active comparator | Device: MedicParticipants receive the Medic programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session. |
| P1 | Experimental | Device: P1Participants receive the Programme 1 (P1) delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session. |
| PM7 | Experimental | Device: PM7Participants receive the PM7 programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Age 18 or over
- Ability to communicate in English and provide informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedicAlso: Medic programmeThe 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. | Device | Medic |
| P1Also: Programme 1Programme 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. | Device | P1 |
| PM7Also: Personalised Medic Programme v7Personalised 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. | Device | PM7 |
Primary outcome
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.
2 secondary outcomes
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.
Discomfort during NMES stimulation
Time frame: During the 30-minute stimulation session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 39143586Kumaran B, Targett D, Watson T. Benefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial. BMC Geriatr. 2024 Aug 14;24(1):683. doi: 10.1186/s12877-024-05271-z.
- Background: PubMed 24997200Varatharajan L, Williams K, Moore H, Davies AH. The effect of footplate neuromuscular electrical stimulation on venous and arterial haemodynamics. Phlebology. 2015 Oct;30(9):648-50. doi: 10.1177/0268355514542682. Epub 2014 Jul 4.
- Individual participant dataSharing planned: 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.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joey O Porter principal investigator
Actegy Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medic, P1 and PM7 in people with Healthy, run by Joey Porter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joey O Porter, MSc (+44 7415605740, joseph.porter@actegy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07666828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.