Validation of New sEMG Electrode Placement Guidelines for the Triceps Surae in Post-stroke Individuals (Vest-P)

June 1, 2026 updated by: University Hospital, Ghent

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Ghent University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Persons after stroke.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Persons after stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At study enrollment and a second time at least two weeks later.
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.
At study enrollment.
Triceps surae muscle geometry
Time Frame: At study enrollment.
Triceps surae muscle geometry will be measured using 3D freehand ultrasound.
At study enrollment.
Muscle-tendon junction displacement of the lateral gastrocnemius during walking.
Time Frame: At study enrollment.
This will be measured with dynamic 2D ultrasound.
At study enrollment.
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.
At study enrollment.
Muscle-tendon junction displacement of the medial gastrocnemius during walking.
Time Frame: At study enrollment.
This will be measured using dynamic 2D ultrasound.
At study enrollment.
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.
At study enrollment.
Quality features of the surface electromyography signals obtained from the EPICA electrodes during the dynamic tasks.
Time Frame: At study enrollment.
At study enrollment.
Quality features of the surface electromyography signals obtained from the SENIAM electrodes during the dynamic tasks.
Time Frame: At study enrollment.
At study enrollment.
Passive ankle range of motion.
Time Frame: At study enrollment.
This will be measured using a manual goniometer.
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.
At study enrollment.
Surface electromyography amplitude during the dynamic tasks.
Time Frame: At study enrollment.
At study enrollment.
Surface electromyography timing during the dynamic tasks.
Time Frame: At study enrollment.
At study enrollment.
Spatiotemporal parameters derived from inertial measurement units
Time Frame: At study enrollment.
At study enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ONZ-2025-0433
  • 11PKX24N (Other Grant/Funding Number: Research foundation Flanders)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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