An interventional study of NMES in Healthy Adult Participants, sponsored by Kieron.Day. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Kieron.Day · Not applicable, Interventional, and Treatment
The primary objective of this study to assess the haemodynamic effects of unilateral and bilateral geko® T3 stimulation on lower-limb circulation, measured by femoral artery and vein blood flow.
Prior to baseline measurements, participants will undergo a 5 minute stabilisation period to allow haemodynamic parameters to equilibrate under resting conditions. Following stabilisation, Doppler ultrasound measurements will be taken at the common femoral artery followed by the common femoral vein on both lower limbs to determine Peak Systolic Velocity (PSV) and Volume Flow (mL/min). These baseline assessments will establish reference values for arterial and venous blood flow prior to activation of the geko® T3 device.
Unilateral Stimulation.
The geko® T3 device will be applied to one leg (the geko leg), while the contralateral leg will remain unstimulated. After device activation, a 5 minute stabilisation period will be observed to allow haemodynamic parameters to reach a steady state before measurements begin. Following stabilisation, Doppler ultrasound measurements will be performed first at the femoral artery, then at the femoral vein, on both legs to determine PSV and Volume Flow (mL/min). This data will be used to assess differences in arterial and venous blood flow between the stimulated (geko leg) and non-stimulated (contralateral) limb.
The geko® T3 devices will be applied to both legs simultaneously. After activation, a 5 minute stabilisation period will again be observed to allow haemodynamic parameters to stabilise prior to measurement.
Following stabilisation, Doppler ultrasound assessments will be obtained in the same order, femoral artery first, followed by femoral vein, on both legs to measure PSV and Volume Flow (mL/min). The order of stimulation phases will be fixed, with unilateral stimulation always preceding bilateral stimulation.
A 5 minute rest period will separate the two stimulation phases to allow haemodynamic parameters to return to baseline before commencing the next phase. At each phase (Baseline, Unilateral, and Bilateral), Doppler ultrasound (femoral artery and vein) will be performed on both limbs.
For Doppler assessments, three consecutive recordings at each site (artery and vein), each approximately 20 seconds in duration, will be collected and averaged per phase.
Participants will remain seated throughout all assessments to ensure stable and consistent haemodynamic conditions.
The total participation time for each participant is expected to be approximately 2½ hours, including informed consent, setup, stabilisation and rest periods, all measurements, and debrief.
Kieron.Day is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit.
Device: NMES
Exploring Haemodynamic Effects of Unilateral vs Bilateral NMES of the Lower Limb.
Femoral vein peak systolic velocity during geko® T3 stimulation
Femoral vein peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Time frame: During a single study visit of approximately 2.5 hours
Femoral vein volume flow during geko® T3 stimulation
Femoral vein volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Time frame: During a single study visit of approximately 2.5 hours
Femoral artery peak systolic velocity during geko® T3 stimulation
Femoral artery peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Time frame: During a single study visit of approximately 2.5 hours
Femoral artery volume flow during geko® T3 stimulation
Femoral artery volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Time frame: During a single study visit of approximately 2.5 hours
Occurrence of adverse events (AEs)
Occurrence of adverse events (AEs) during the study.
Time frame: Single study visit (approximately 2.5 hours)
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) during the study.
Time frame: Single study visit (approximately 2.5 hours)
Occurrence of adverse device effects (ADEs)
Occurrence of adverse device effects (ADEs) associated with use of the geko® T3 device.
Time frame: Single study visit (approximately 2.5 hours)
Occurrence of serious adverse device effects (SADEs)
Occurrence of serious adverse device effects (SADEs) associated with use of the geko® T3 device.
Time frame: Single study visit (approximately 2.5 hours)
Occurrence of device deficiencies (DDs)
Occurrence of device deficiencies (DDs) associated with the geko® T3 device during the study.
Time frame: Single study visit (approximately 2.5 hours)
Plan to share: Yes — Available upon request.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
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 ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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