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Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes

Can Blood Flow Enhancing Plantar Flexion Electrically Induced Via Textile Electrodes in a Sock Using 1 Hz Frequency Give Better Comfort and Energy Efficiency as Compared to 36 Hz ?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082297
Acronym
TTE_PVV_1_36
Enrollment
15
Registered
2023-10-13
Start date
2019-07-17
Completion date
2019-08-13
Last updated
2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Pain

Keywords

Neuromuscular electrical stimulation, Hemodynamics, Physical inactivity

Brief summary

Muscle contractions induced by calf low-intensity neuromuscular electrical stimulation (C-LI-NMES) can increase venous return and may reduce venous thromboembolism. This study aimed to compare the effect of different C-LI-NMES frequencies and plateau times on hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse textile electrodes.

Detailed description

Fifteen healthy participants were stimulated via two 3x3cm transverse textile electrodes integrated in a sock, with ten different combinations of frequency (1Hz or 36Hz) and plateau times (0.5/1.5/3/5/7s), with gradually increasing NMES-intensity until plantar flexion-induction. At this point, popliteal peak venous velocity (PVV), time-averaged mean velocity (TAMV) and ejection volume (EV) were assessed by Doppler-ultrasound, discomfort by a numerical rating scale (NRS, 0-10) and values for current amplitude and energy were calculated based on the NMES-device´s intensity level. Values expressed with median (interquartile range), significance set to p\<0.05.

Interventions

DEVICEChattanooga Physio, DJO, neuromuscular electrical stimulation

Neuromuscular electrical stimulation (NMES) was applied with a device called Chattanooga Physio (DJO), testing 10 different combinations of parameter-settings. The parameter-settings that were varied and combined were frequency (1Hz and 36Hz) and plateau times (0.5s, 1.5s, 3s, 5s, 7s). The NMES was applied to the calf of the participants via transversally placed textile electrodes (3x3 cm) integrated in a sock starting with very low current amplitude followed by gradual small increases in current amplitude until induction of ankle plantar flexion, at which time-point the outcomes where measured.

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Participants did not receive information about what parameter-settings that were used for the different tests.

Intervention model description

Repeated measures tests on on each of the 15 participants, comparing outcomes for no intervention and 10 different interventions in the form of variations in parameter-settings of neuromuscular electrical stimulation, with gradually increasing current amplitude until induction of ankle plantar flexion.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-99 years of age * Voluntary participation

Exclusion criteria

* Pregnancy * Pacemaker * Ongoing thromboprophylaxis * Skin wounds * Vascular abnormalities * Previous vascular system surgery in the lower limbs

Design outcomes

Primary

MeasureTime frameDescription
Peak venous velocity (PVV)Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the interventionPeak venous velocity (centimeters per second) will be assesed by Doppler ultrasound of in the popliteal vein
Time averaged mean velocity (TAMV)Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the interventionTime averaged mean velocity will be assesed by Doppler ultrasound in the popliteal vein (centimeters per second)
Average duration of blood pulse (ADBP)Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the interventionAverage duration of blood pulse will be assesed by Doppler ultrasound in the popliteal vein (seconds)
Ejection volume (EV)Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the interventionEjection volume of blood will be assesed by Doppler ultrasound in the popliteal vein (milliliters)

Secondary

MeasureTime frameDescription
Current amplitudeDay 1 during ankle plantar flexion was induced by the interventionCurrent amplitude in milliampere (mA) will be assessed by using stepwise increases (typically 1mA) on the NMES device until a plantar flexion is induced
EnergyDay 1 during ankle plantar flexion was induced by the interventionEnergy per stimulation cycle in millijoule (mJ) will be assessed by using stepwise increases (typically 1mA) on the NMES device until a plantar flexion is induced, at which point the energy consumption (mJ) is calculated.
Numerical rating scale (NRS)Day 1 during ankle plantar flexion was induced by the interventionDiscomfort estimated using a numerical rating scale from 0 (no pain) to 10 (worst pain)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026