Clinical trial NCT06082297: Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes
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 ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Pain
Keywords: Neuromuscular electrical stimulation
Hemodynamics
Physical inactivity
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Peak venous velocity (PVV)
timeFrame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
measure: Time averaged mean velocity (TAMV)
timeFrame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
measure: Average duration of blood pulse (ADBP)
timeFrame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
measure: Ejection volume (EV)
timeFrame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
Secondary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Day 1 during ankle plantar flexion was induced by the intervention
measure: Current amplitude
timeFrame: Day 1 during ankle plantar flexion was induced by the intervention
measure: Energy
timeFrame: Day 1 during ankle plantar flexion was induced by the intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska university Hospital
Study officials:
affiliation: Karolinska Institutet
name: Paul Ackermann, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: