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Recruiting NCT07387328

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

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Electrode-muscle boundary distances for EPICA-electrodes [Time frame: At study enrollment and a second time at least two weeks later.]
  • Electrode-muscle boundary distances for SENIAM-electrodes [Time frame: At study enrollment.]
  • Triceps surae muscle geometry [Time frame: At study enrollment.]
  • Muscle-tendon junction displacement of the lateral gastrocnemius during walking. [Time frame: At study enrollment.]
  • Muscle-tendon junction displacement of the lateral gastrocnemius during a heel raise. [Time frame: At study enrollment.]
  • Muscle-tendon junction displacement of the medial gastrocnemius during walking. [Time frame: At study enrollment.]
  • Muscle-tendon junction displacement of the medial gastrocnemius during a heel raise. [Time frame: At study enrollment.]
  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

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. PMID 41218536

Identifiers

NCT: NCT07387328 · ONZ-2025-0433 · 11PKX24N

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗