Muscle Activity of the Gastrocnemius and Soleus Muscles by Surface Electromyography.

April 29, 2025 updated by: Alejandro Caña Pino, University of Extremadura

Muscle Activity of the Gastrocnemius and Soleus Muscles During a Specific Contraction Task Assessed by Surface Electromyography

This cross-sectional, comparative study aims to evaluate and compare the surface electromyographic (sEMG) activity of the gastrocnemius (medial and lateral) and soleus muscles during static and dynamic contraction tasks. Participants will perform three tests-resting state, isometric, concentric, and eccentric contraction, and dynamic gait-with bilateral measurements. A subgroup analysis will examine muscle activity variations based on foot posture, using the Foot Posture Index (FPI). The study uses the validated mDurance® sEMG system to obtain objective data under controlled lab conditions. The findings will enhance understanding of the functional role of each muscle and could inform rehabilitation and injury prevention strategies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Raquel MA Dra. Raquel Mayordomo Acevedo, PhD
  • Phone Number: 927427000
  • Email: rmayordo@unex.es

Study Locations

  • Spain
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Centro Universitario de Plasencia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of healthy young adults enrolled in undergraduate programs at the Centro Universitario de Plasencia, University of Extremadura (Spain). Participants will be recruited through internal communication channels at the university. All participants will voluntarily agree to take part in the study and sign an informed consent form. Eligibility criteria include individuals aged 18 to 30 years, with no history of recent musculoskeletal injuries or surgeries in the lower limbs, and able to perform the required physical tasks without restriction. Subjects with foot postural alterations will also be included for later comparison with subjects without foot postural alterations.

Description

Inclusion Criteria:

  • Age between 18 and 30 years.
  • No history of severe musculoskeletal disorders in the lower limbs.
  • No recent surgery or injury in the last 6 months.
  • No dermatological conditions affecting electrode placement.
  • Not allergic to adhesives.

  • Ability to perform the task without limitation.

    •. No high-intensity exercise in the 12 hours before testing

  • Ability to provide informed consent and complete the assessment

Exclusion Criteria:

  • Reduced lower limb mobility.
  • Neuromuscular or skeletal conditions affecting the calf region.
  • Intense physical activity 12 hours before testing.
  • Lack of informed consent.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle activation, microvolts (μV)
Time Frame: Baseline or Day 1. During a single assessment session (~30 minutes).
Muscle activation (μV) as recorded by mDurance® sEMG system during the contraction protocol (soleus vs. gastrocnemius).
Baseline or Day 1. During a single assessment session (~30 minutes).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RMS (root mean square) and peak EMG signal values (μV)
Time Frame: Baseline or Day 1. During the same assessment session
RMS and peak EMG signal values (μV): average muscle activity measured by RMS (root mean square) and maximum voluntary contraction by peak activation. Comparison of Medial vs. Lateral Gastrocnemius Activation. Comparison of Medial vs. Lateral Gastrocnemius Activation
Baseline or Day 1. During the same assessment session
Differences in muscle activity by contraction type (μV)
Time Frame: Baseline or Day 1. Immediately after the execution of each contraction type during the session
Differences in muscle activity by contraction type (μV): Effect of contraction type (isometric/concentric/eccentric) on muscle activity. Comparison of Medial vs. Lateral Gastrocnemius Activation
Baseline or Day 1. Immediately after the execution of each contraction type during the session
Activity differences by foot posture (pronated, neutral, supinated)
Time Frame: Baseline or Day 1. Immediately after foot posture assessment during the same session
Muscle activation of the gastrocnemius and soleus will be compared based on foot posture (pronated, neutral, or supinated). This aims to identify whether foot type influences activation patterns.
Baseline or Day 1. Immediately after foot posture assessment during the same session
Correlation with physical activity level Physical Activity Questionnaire (IPAQ-short version)
Time Frame: Baseline or Day 1. Collected at baseline before EMG assessment
Correlation with physical activity level (IPAQ-short version): Correlation with sociodemographic and anthropometric factors (age, sex, BMI, activity level). Self-reported questionnaire assessing physical activity over the last 7 days. Physical activity is categorized as Low, Moderate, or High based on total MET-minutes/week. Sitting time is recorded separately as an indicator of sedentary behavior.
Baseline or Day 1. Collected at baseline before EMG assessment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Extremadura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: María Victoria CM María Victoria Cáceres Madrid, PhD, Departamento de Enfermería. Centro Universitario de Plasencia. Universidad de Extremadura
  • Principal Investigator: Olga LR Olga López Ripado, MSc, Departamento de Anatomía, Biología Celular y Zoología. Centro Universitario de Plasencia. Universidad de Extremadura
  • Principal Investigator: Alejando CP Alejandro Caña Pino, PhD, Departamento de Terapéutica Médico-Quirúrgica. Facultad de Enfermería y Terapia Ocupacional. Universidad de Extremadura
  • Principal Investigator: Marina FJ Fontán Jiménez, PhD, Departamento de Enfermería. Centro Universitario de Plasencia. Universidad de Extremadura
  • Study Director: Raquel MA Raquel Mayordomo Acevedo, PhD, Departamento de Anatomía, Biología Celular y Zoología. Centro Universitario de Plasencia. Universidad de Extremadura

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 150425

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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