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

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJoey Porter

About this trial

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.

Eligibility criteria

Qualifiers

Healthy

Age 18 or over

Ability to communicate in English and provide informed consent

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Medic
  • P1
  • PM7

Treatment groups

24 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Joey Porter

Lead sponsor

Actegy Ltd.

Sponsor institution