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

NCT ID: NCT06082297

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2019-08-13

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.

Conditions

Hemodynamic Instability; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chattanooga Physio, DJO, neuromuscular electrical stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Device name and manufacturer:

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paul Ackermann

Professor,MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Ackermann, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska university Hospital

Stockholm, , Sweden

Countries

Sweden

References

Juthberg R, Flodin J, Aliaga N, Guo L, Rodriguez S, Persson NK, Ackermann PW. Electrically induced hemodynamic enhancement via sock-integrated electrodes is more comfortable and efficient at 1 hz as compared to 36 hz. Sci Rep. 2025 Apr 15;15(1):12944. doi: 10.1038/s41598-025-97431-3.

Reference Type: DERIVED

PMID: 40234723 (View on PubMed)

Other Identifiers

TTE_PVV_1_vs_36_Hz

Identifier Type: -

Identifier Source: org_study_id