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Completed

NCT Number: NCT06082297

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

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.

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Key information

Conditions

Hemodynamic Instability Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska university Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chattanooga Physio, DJO, neuromuscular electrical stimulation

Device

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.

Other names: Device name and manufacturer:

Primary outcomes

  1. Peak venous velocity (PVV)

    Time frame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

    Peak venous velocity (centimeters per second) will be assesed by Doppler ultrasound of in the popliteal vein

  2. Time averaged mean velocity (TAMV)

    Time frame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

    Time averaged mean velocity will be assesed by Doppler ultrasound in the popliteal vein (centimeters per second)

  3. Average duration of blood pulse (ADBP)

    Time frame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

    Average duration of blood pulse will be assesed by Doppler ultrasound in the popliteal vein (seconds)

  4. Ejection volume (EV)

    Time frame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

    Ejection volume of blood will be assesed by Doppler ultrasound in the popliteal vein (milliliters)

Secondary outcomes

  1. Numerical rating scale (NRS)

    Time frame: Day 1 during ankle plantar flexion was induced by the intervention

    Discomfort estimated using a numerical rating scale from 0 (no pain) to 10 (worst pain)

  2. Current amplitude

    Time frame: Day 1 during ankle plantar flexion was induced by the intervention

    Current amplitude in milliampere (mA) will be assessed by using stepwise increases (typically 1mA) on the NMES device until a plantar flexion is induced

  3. Energy

    Time frame: Day 1 during ankle plantar flexion was induced by the intervention

    Energy 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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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 ?

Acronym: TTE_PVV_1_36

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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