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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06082297

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

16.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability Pain	Device: Chattanooga Physio, DJO, neuromuscular electrical stimulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

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.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.

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Basic Science

Official 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 ?

Actual Study Start Date :

Jul 17, 2019

Actual Primary Completion Date :

Aug 13, 2019

Actual Study Completion Date :

Aug 13, 2019

Arms and Interventions

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:

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:

Outcome Measures

Primary Outcome Measures

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
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)
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)
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)

Secondary Outcome Measures

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)
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska university Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator: Paul Ackermann, PhD, MD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul Ackermann, Professor,MD,PhD, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT06082297

Other Study ID Numbers:

TTE_PVV_1_vs_36_Hz

First Posted:

Oct 13, 2023

Last Update Posted:

Oct 13, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paul Ackermann, Professor,MD,PhD, Karolinska University Hospital

Neuromuscular electrical stimulation

Hemodynamics

Physical inactivity

Study Results

No Results Posted as of Oct 13, 2023