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 ?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Average duration of blood pulse (ADBP)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
Participants did not receive information about what parameter-settings that were used for the different tests.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Chattanooga Physio, DJO, neuromuscular electrical stimulation (Device)
Outcomes
Primary Outcomes
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)
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)
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)
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
Secondary Outcomes
- Current amplitude(Day 1 during ankle plantar flexion was induced by the intervention)
- Numerical rating scale (NRS)(Day 1 during ankle plantar flexion was induced by the intervention)
- Energy(Day 1 during ankle plantar flexion was induced by the intervention)
Investigators
Paul Ackermann
Professor,MD,PhD
Karolinska University Hospital