- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953401
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
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
- Name: Raquel MA Dra. Raquel Mayordomo Acevedo, PhD
- Phone Number: 927427000
- Email: rmayordo@unex.es
Study Locations
-
-
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
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
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
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
Investigators
- 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)
September 1, 2025
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
April 21, 2025
First Submitted That Met QC Criteria
April 29, 2025
First Posted (Actual)
May 1, 2025
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID 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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