StrokeVest-PNCT07387328
Validation of New sEMG Electrode Placement Guidelines for the Triceps Surae in Post-stroke Individuals
An observational study of Stroke, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Background and rationale: Surface electromyography (EMG) is a non-invasive method to measure muscle activity, among others in people after a stroke during gait analysis. Measurement quality is strongly influenced by electrode placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2026to 31 Oct 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons after stroke.
Who may be able to join
- Adult individuals who have experienced a stroke (CVA or cerebrovascular accident).
- Have no other neurological disorder.
- Are able to lie in the prone position for approximately one and a half hours.
- Are able to walk without shoes for the walking component (only applicable to participants who will perform walking). The use of an assistive device such as a walking stick (or similar) is permitted.
Who cannot join
- Presence of other neurological or orthopedic conditions that may influence the measurements and results (e.g., Parkinson's disease, peripheral neuropathy of the lower limbs, severe ankle osteoarthritis limiting range of motion, etc.).
- Having undergone a surgical intervention on the hemiparetic lower leg (e.g., ankle joint arthrodesis, etc.).
- Severe cognitive impairments that prevent understanding participation in the study (assessed using the AbilityQ).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
Hiruz, +32 9 332 05 30, hiruz@uzgent.be
About this study
Background and rationale:
Surface electromyography (EMG) is a non-invasive method to measure muscle activity, among others in people after a stroke during gait analysis. Measurement quality is strongly influenced by electrode placement. However, the commonly used SENIAM guidelines do not take individual variations in muscle morphology into account, which can lead to inaccurate measurements. In previous research demonstrated that the standard placement on the triceps surae (medial and lateral gastrocnemius and soleus) was suboptimal at the group level and sometimes even problematic at the individual level. Therefore, new placement guidelines (EPICA guidelines, Electrode Placement for Individual Calf Anatomy) were developed, which are currently being tested in healthy individuals.
Read more
Method:
In this project aims to validate these newly developed guidelines in people after a stroke who exhibit atrophy of their calf muscles. For each participant, electrode positions on the hemiplegic side will be determined according to our guidelines while the participant is lying prone. Circular stickers will be used instead of actual EMG electrodes and will be placed according to the EPICA guidelines as well as according to the SENIAM guidelines. Subsequently, the muscle borders of the triceps surae will be identified on the participant's leg using 2D ultrasound. Afterwards, the distance between the electrodes and the surrounding muscle borders will be measured to map electrode placement on the muscle in order to validate the guidelines.
In the second part of this study, 3D ultrasound recordings will be made of the soleus, medial gastrocnemius, and lateral gastrocnemius with the electrodes (stickers) on these muscles, so that during image processing, electrode positions can be visualized relative to the entire muscle, including along the depth axis. In addition, participants who can safely walk without an ankle-foot orthosis will be asked to walk a maximum of five times ten meters. Additionally, an ultrasound probe will be attached to the leg to investigate how the electrode position relates to the muscle-tendon junction during movement. Subsequently, actual electrodes will also be placed to record muscle activity during walking and heel raises.
Furthermore, all participants will be asked to do a heel raise to activate the calf muscles. As such, the quality of the EMG signals will be evaluated. Other measurements will included: Fugl-Meyer Assessment of the lower limb, measure passive ankle range of motion with a goniometer, and measure lower leg length with a tape measure. These will be used as descriptive parameters of our study population.
Patients will be asked on a voluntary basis to participate in a second, short measurement approximately two weeks after the first session. During this measurement, electrode placement will again be performed according to the EPICA guidelines. 3D ultrasound will again be used to calculate the distances between the electrodes and the muscle borders. This second measurement is necessary to investigate the test-retest reliability of the EPICA guidelines in people after a stroke.
- Conditions
- Stroke
- Keywords
- Surface electromyography, guidelines, SENIAM, 3D freehand ultrasound
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons after stroke. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrode-muscle boundary distances for EPICA-electrodes
These distances, measured with a tape measure, will be obtained between the EPICA electrode positions and the muscle boundaries as visualized using 2D ultrasound.
Measured: At study enrollment and a second time at least two weeks later.
Electrode-muscle boundary distances for SENIAM-electrodes
These distances, measured with a tape measure, will be obtained between the SENIAM electrode positions and the muscle boundaries as visualized using 2D ultrasound.
Measured: At study enrollment.
Triceps surae muscle geometry
Triceps surae muscle geometry will be measured using 3D freehand ultrasound.
Measured: At study enrollment.
Muscle-tendon junction displacement of the lateral gastrocnemius during walking.
This will be measured with dynamic 2D ultrasound.
Measured: At study enrollment.
Muscle-tendon junction displacement of the lateral gastrocnemius during a heel raise.
This will be measured using dynamic 2D ultrasound.
Measured: At study enrollment.
Muscle-tendon junction displacement of the medial gastrocnemius during walking.
This will be measured using dynamic 2D ultrasound.
Measured: At study enrollment.
Muscle-tendon junction displacement of the medial gastrocnemius during a heel raise.
This will be measured using dynamic 2D ultrasound.
Measured: At study enrollment.
Quality features of the surface electromyography signals obtained from the EPICA electrodes during the dynamic tasks.
Measured: At study enrollment.
Quality features of the surface electromyography signals obtained from the SENIAM electrodes during the dynamic tasks.
Measured: At study enrollment.
Fugl-Meyer Assessment score of the paretic lower limb.
Minumum score is 0 and maximum score is 34. A higher score involves a less impaired hemiparetic leg.
Measured: At study enrollment.
Passive ankle range of motion.
This will be measured using a manual goniometer.
Measured: At study enrollment.
Surface electromyography amplitude during the dynamic tasks.
Measured: At study enrollment.
Surface electromyography timing during the dynamic tasks.
Measured: At study enrollment.
Spatiotemporal parameters derived from inertial measurement units
Measured: At study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start17 Apr 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Vrije Universiteit Brussel, Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387328
- Sponsor's protocol ID
- ONZ-2025-0433
- Other IDs
- 11PKX24N
- Acronym
- Vest-P
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Vlieger D, Bosman L, Swinnen E, Besomi M, Aeles J. Assessment of common electrode placement methods for surface electromyography recordings of the triceps surae muscles. J Electromyogr Kinesiol. 2025 Dec;85:103080. doi: 10.1016/j.jelekin.2025.103080. Epub 2025 Oct 24.
PubMed 41218536
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of New sEMG Electrode Placement Guidelines for the Triceps Surae in Post-stroke Individuals
- ClinicalTrials.gov ID
- NCT07387328
- Acronym / sponsor ID
- Vest-P / ONZ-2025-0433
- Conditions
- Stroke
- Keywords
- Surface electromyography, guidelines, SENIAM, 3D freehand ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Vrije Universiteit Brussel, Research Foundation Flanders
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Background and rationale:
Surface electromyography (EMG) is a non-invasive method to measure muscle activity, among others in people after a stroke during gait analysis. Measurement quality is strongly influenced by electrode placement. However, the commonly used SENIAM guidelines do not take individual variations in muscle morphology into account, which can lead to inaccurate measurements. In previous research demonstrated that the standard placement on the triceps surae (medial and lateral gastrocnemius and soleus) was suboptimal at the group level and sometimes even problematic at the individual level. Therefore, new placement guidelines (EPICA guidelines, Electrode Placement for Individual Calf Anatomy) were developed, which are currently being tested in healthy individuals.
Method:
In this project aims to validate these newly developed guidelines in people after a stroke who exhibit atrophy of their calf muscles. For each participant, electrode positions on the hemiplegic side will be determined according to our guidelines while the participant is lying prone. Circular stickers will be used instead of actual EMG electrodes and will be placed according to the EPICA guidelines as well as according to the SENIAM guidelines. Subsequently, the muscle borders of the triceps surae will be identified on the participant's leg using 2D ultrasound. Afterwards, the distance between the electrodes and the surrounding muscle borders will be measured to map electrode placement on the muscle in order to validate the guidelines.
In the second part of this study, 3D ultrasound recordings will be made of the soleus, medial gastrocnemius, and lateral gastrocnemius with the electrodes (stickers) on these muscles, so that during image processing, electrode positions can be visualized relative to the entire muscle, including along the depth axis. In addition, participants who can safely walk without an ankle-foot orthosis will be asked to walk a maximum of five times ten meters. Additionally, an ultrasound probe will be attached to the leg to investigate how the electrode position relates to the muscle-tendon junction during movement. Subsequently, actual electrodes will also be placed to record muscle activity during walking and heel raises.
Furthermore, all participants will be asked to do a heel raise to activate the calf muscles. As such, the quality of the EMG signals will be evaluated. Other measurements will included: Fugl-Meyer Assessment of the lower limb, measure passive ankle range of motion with a goniometer, and measure lower leg length with a tape measure. These will be used as descriptive parameters of our study population.
Patients will be asked on a voluntary basis to participate in a second, short measurement approximately two weeks after the first session. During this measurement, electrode placement will again be performed according to the EPICA guidelines. 3D ultrasound will again be used to calculate the distances between the electrodes and the muscle borders. This second measurement is necessary to investigate the test-retest reliability of the EPICA guidelines in people after a stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons after stroke. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons after stroke.
Key inclusion criteria (4 listed)
- Adult individuals who have experienced a stroke (CVA or cerebrovascular accident).
- Have no other neurological disorder.
- Are able to lie in the prone position for approximately one and a half hours.
- Are able to walk without shoes for the walking component (only applicable to participants who will perform walking). The use of an assistive device such as a walking stick (or similar) is permitted.
Key exclusion criteria (3 listed)
- Presence of other neurological or orthopedic conditions that may influence the measurements and results (e.g., Parkinson's disease, peripheral neuropathy of the lower limbs, severe ankle osteoarthritis limiting range of motion, etc.).
- Having undergone a surgical intervention on the hemiparetic lower leg (e.g., ankle joint arthrodesis, etc.).
- Severe cognitive impairments that prevent understanding participation in the study (assessed using the AbilityQ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electrode-muscle boundary distances for EPICA-electrodes
Time frame: At study enrollment and a second time at least two weeks later.
These distances, measured with a tape measure, will be obtained between the EPICA electrode positions and the muscle boundaries as visualized using 2D ultrasound.
Electrode-muscle boundary distances for SENIAM-electrodes
Time frame: At study enrollment.
These distances, measured with a tape measure, will be obtained between the SENIAM electrode positions and the muscle boundaries as visualized using 2D ultrasound.
Triceps surae muscle geometry
Time frame: At study enrollment.
Triceps surae muscle geometry will be measured using 3D freehand ultrasound.
Muscle-tendon junction displacement of the lateral gastrocnemius during walking.
Time frame: At study enrollment.
This will be measured with dynamic 2D ultrasound.
Muscle-tendon junction displacement of the lateral gastrocnemius during a heel raise.
Time frame: At study enrollment.
This will be measured using dynamic 2D ultrasound.
Muscle-tendon junction displacement of the medial gastrocnemius during walking.
Time frame: At study enrollment.
This will be measured using dynamic 2D ultrasound.
Muscle-tendon junction displacement of the medial gastrocnemius during a heel raise.
Time frame: At study enrollment.
This will be measured using dynamic 2D ultrasound.
Quality features of the surface electromyography signals obtained from the EPICA electrodes during the dynamic tasks.
Time frame: At study enrollment.
Quality features of the surface electromyography signals obtained from the SENIAM electrodes during the dynamic tasks.
Time frame: At study enrollment.
Fugl-Meyer Assessment score of the paretic lower limb.
Time frame: At study enrollment.
Minumum score is 0 and maximum score is 34. A higher score involves a less impaired hemiparetic leg.
Passive ankle range of motion.
Time frame: At study enrollment.
This will be measured using a manual goniometer.
Surface electromyography amplitude during the dynamic tasks.
Time frame: At study enrollment.
Surface electromyography timing during the dynamic tasks.
Time frame: At study enrollment.
Spatiotemporal parameters derived from inertial measurement units
Time frame: At study enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 41218536De Vlieger D, Bosman L, Swinnen E, Besomi M, Aeles J. Assessment of common electrode placement methods for surface electromyography recordings of the triceps surae muscles. J Electromyogr Kinesiol. 2025 Dec;85:103080. doi: 10.1016/j.jelekin.2025.103080. Epub 2025 Oct 24.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrode-muscle boundary distances for EPICA-electrodes (time frame: At study enrollment and a second time at least two weeks later.). The study lists 14 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 NCT07387328, 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 3 Jun 2026.