Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes (TTE_PVV_1_36)

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 ?

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hemodynamic Instability
• Intervention / Treatment: Device: Chattanooga Physio, DJO, neuromuscular electrical stimulation

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm where repeated measures where performed in 15 participants.; 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.

Device: Chattanooga 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.; Other Names: Device name and manufacturer:

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale (NRS)	Discomfort estimated using a numerical rating scale from 0 (no pain) to 10 (worst pain)	Day 1 during ankle plantar flexion was induced by the intervention
Current amplitude	Current amplitude in milliampere (mA) will be assessed by using stepwise increases (typically 1mA) on the NMES device until a plantar flexion is induced	Day 1 during ankle plantar flexion was induced by the intervention
Energy	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.	Day 1 during ankle plantar flexion was induced by the intervention

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Paul Ackermann, PhD, MD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): August 13, 2019
• Study Completion (Actual): August 13, 2019

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Physical inactivity; Hemodynamics; Neuromuscular electrical stimulation
• Other Study ID Numbers: TTE_PVV_1_vs_36_Hz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently there is no plan to share individual participant data, but individual participant data may be shared upon reasonable request in the future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No