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

NCT07666828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-29

No results posted yet for this study

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.

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.

Conditions

  • Healthy

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Joey Porter

    lead INDUSTRY

Principal Investigators

  • Joey Porter · Actegy Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2027-01-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666828 on ClinicalTrials.gov