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

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Pain
• Interventions: Device: Chattanooga Physio, DJO, neuromuscular electrical stimulation

• Registration Number: NCT06082297
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2019-07-17
• Primary Completion: 2019-08-13
• Study Completion: 2019-08-13
• Study First Submitted: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single arm where repeated measures where performed in 15 participants.	Chattanooga Physio, DJO, neuromuscular electrical stimulation	Each of the 15 participants in the arm was, in addition to the resting state (no intervention), exposed to 10 different interventions repeated after each other to enable repeated measures of the outcomes.

Primary Outcome Measures

Name	Time	Method
Time averaged mean velocity (TAMV)	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)
Ejection volume (EV)	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)
Peak venous velocity (PVV)	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
Average duration of blood pulse (ADBP)	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)

Secondary Outcome Measures

Name	Time	Method
Current amplitude	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
Numerical rating scale (NRS)	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)
Energy	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.

Trial Locations

Locations (1)

Karolinska university Hospital; 🇸🇪 Stockholm, Sweden