- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387328
Validation of New sEMG Electrode Placement Guidelines for the Triceps Surae in Post-stroke Individuals (Vest-P)
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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Recruiting
- Ghent University Hospital
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Contact:
- Hiruz
- Phone Number: +32 9 332 05 30
- Email: hiruz@uzgent.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Persons after stroke.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Electrode-muscle boundary distances for EPICA-electrodes
Time Frame: At study enrollment and a second time at least two weeks later.
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These distances, measured with a tape measure, will be obtained between the EPICA electrode positions and the muscle boundaries as visualized using 2D ultrasound.
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At study enrollment and a second time at least two weeks later.
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Electrode-muscle boundary distances for SENIAM-electrodes
Time Frame: At study enrollment.
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These distances, measured with a tape measure, will be obtained between the SENIAM electrode positions and the muscle boundaries as visualized using 2D ultrasound.
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At study enrollment.
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Triceps surae muscle geometry
Time Frame: At study enrollment.
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Triceps surae muscle geometry will be measured using 3D freehand ultrasound.
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At study enrollment.
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Muscle-tendon junction displacement of the lateral gastrocnemius during walking.
Time Frame: At study enrollment.
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This will be measured with dynamic 2D ultrasound.
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At study enrollment.
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Muscle-tendon junction displacement of the lateral gastrocnemius during a heel raise.
Time Frame: At study enrollment.
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This will be measured using dynamic 2D ultrasound.
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At study enrollment.
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Muscle-tendon junction displacement of the medial gastrocnemius during walking.
Time Frame: At study enrollment.
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This will be measured using dynamic 2D ultrasound.
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At study enrollment.
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Muscle-tendon junction displacement of the medial gastrocnemius during a heel raise.
Time Frame: At study enrollment.
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This will be measured using dynamic 2D ultrasound.
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At study enrollment.
|
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Quality features of the surface electromyography signals obtained from the EPICA electrodes during the dynamic tasks.
Time Frame: At study enrollment.
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At study enrollment.
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Quality features of the surface electromyography signals obtained from the SENIAM electrodes during the dynamic tasks.
Time Frame: At study enrollment.
|
At study enrollment.
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|
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Passive ankle range of motion.
Time Frame: At study enrollment.
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This will be measured using a manual goniometer.
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At study enrollment.
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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.
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At study enrollment.
|
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Surface electromyography amplitude during the dynamic tasks.
Time Frame: At study enrollment.
|
At study enrollment.
|
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Surface electromyography timing during the dynamic tasks.
Time Frame: At study enrollment.
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At study enrollment.
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Spatiotemporal parameters derived from inertial measurement units
Time Frame: At study enrollment.
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At study enrollment.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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