Hemodynamic InstabilityTTE_PVV_1_36NCT06082297
Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes
A study testing Chattanooga Physio, DJO, neuromuscular electrical stimulation in people with Hemodynamic Instability and Pain, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Pain
- What is being tested?
- Chattanooga Physio, DJO, neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jul 2019to 13 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-99 years of age
- Voluntary participation
Who cannot join
- Pregnancy
- Pacemaker
- Ongoing thromboprophylaxis
- Skin wounds
- Vascular abnormalities
- Previous vascular system surgery in the lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
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 ?
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.
Read the 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
- Being tested
- Chattanooga Physio, DJO, neuromuscular electrical stimulation
- Keywords
- Neuromuscular electrical stimulation, Hemodynamics, Physical inactivity
- Medical subject headings
- Pain, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chattanooga Physio, DJO, neuromuscular electrical stimulationDevice
Also called Device name and manufacturer:
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm where repeated measures where performed in 15 participants. | Experimental | 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. Receives: Device: Chattanooga Physio, DJO, neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak venous velocity (PVV)
Peak venous velocity (centimeters per second) will be assesed by Doppler ultrasound of in the popliteal vein
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
Secondary outcomes (3)
Numerical rating scale (NRS)
Discomfort estimated using a numerical rating scale from 0 (no pain) to 10 (worst pain)
Measured: 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
Measured: 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.
Measured: Day 1 during ankle plantar flexion was induced by the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start17 Jul 2019
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ackermann, Karolinska University Hospital
- Investigators
- Paul Ackermann, PhD, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082297
- Sponsor's protocol ID
- TTE_PVV_1_vs_36_Hz
- Acronym
- TTE_PVV_1_36
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is no plan to share individual participant data, but individual participant data may be shared upon reasonable request in the future.
Publications
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.
PubMed 40234723
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ?
- ClinicalTrials.gov ID
- NCT06082297
- Acronym / sponsor ID
- TTE_PVV_1_36 / TTE_PVV_1_vs_36_Hz
- Conditions
- Hemodynamic Instability, Pain
- Keywords
- Neuromuscular electrical stimulation, Hemodynamics, Physical inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm where repeated measures where performed in 15 participants. | Experimental | Device: Chattanooga Physio, DJO, neuromuscular electrical stimulationEach 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-99 years of age
- Voluntary participation
Key exclusion criteria (6 listed)
- Pregnancy
- Pacemaker
- Ongoing thromboprophylaxis
- Skin wounds
- Vascular abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chattanooga Physio, DJO, neuromuscular electrical stimulationAlso: Device name and manufacturer: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. | Device | Single arm where repeated measures where performed in 15 participants. |
Primary outcome
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
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)
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)
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)
3 secondary outcomes
Numerical rating scale (NRS)
Time frame: Day 1 during ankle plantar flexion was induced by the intervention
Current amplitude
Time frame: Day 1 during ankle plantar flexion was induced by the intervention
Energy
Time frame: Day 1 during ankle plantar flexion was induced by the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Derived from this study: PubMed 40234723Juthberg 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.
- Individual participant dataSharing planned: No. Currently there is no plan to share individual participant data, but individual participant data may be shared upon reasonable request in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Ackermann, PhD, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chattanooga Physio, DJO, neuromuscular electrical stimulation in people with Hemodynamic Instability and Pain, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak venous velocity (PVV) (time frame: Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06082297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.