Muscle ActivityNCT06953401
Muscle Activity of the Gastrocnemius and Soleus Muscles by Surface Electromyography.
An observational study of Muscle Activity and Electromyography, run by University of Extremadura at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Activity, Electromyography, Lower Limb
- What is being tested?
- Muscle contraction protocol for electromyographic assessment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Reduced lower limb mobility.
- Neuromuscular or skeletal conditions affecting the calf region.
- Intense physical activity 12 hours before testing.
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Muscle Activity, Electromyography, Lower Limb
- Being tested
- Muscle contraction protocol for electromyographic assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle contraction protocol for electromyographic assessmentOther
Participants will perform a set of standardized lower limb muscle contractions (isometric, concentric, and eccentric) involving the gastrocnemius and soleus muscles while lying on an examination table and in standing position both static and dynamic as well as walking. Surface electromyography (mDurance® sEMG system) will be used to record muscle activation during each phase. The task is designed for physiological measurement only and does not constitute a therapeutic intervention. Protocol includes 3 trials per muscle and side, using standardized test conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activation, microvolts (μV)
Muscle activation (μV) as recorded by mDurance® sEMG system during the contraction protocol (soleus vs. gastrocnemius).
Measured: Baseline or Day 1. During a single assessment session (~30 minutes).
Secondary outcomes (4)
RMS (root mean square) and peak EMG signal values (μV)
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
Measured: Baseline or Day 1. During the same assessment session
Differences in muscle activity by contraction type (μV)
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
Measured: Baseline or Day 1. Immediately after the execution of each contraction type during the session
Activity differences by foot posture (pronated, neutral, supinated)
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.
Measured: Baseline or Day 1. Immediately after foot posture assessment during the same session
Correlation with physical activity level Physical Activity Questionnaire (IPAQ-short version)
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.
Measured: Baseline or Day 1. Collected at baseline before EMG assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
- Investigators
- María Victoria CM María Victoria Cáceres Madrid, PhD, Principal investigator, Departamento de Enfermería. Centro Universitario de Plasencia. Universidad de ExtremaduraOlga LR Olga López Ripado, MSc, Principal investigator, Departamento de Anatomía, Biología Celular y Zoología. Centro Universitario de Plasencia. Universidad de ExtremaduraAlejando CP Alejandro Caña Pino, PhD, Principal investigator, Departamento de Terapéutica Médico-Quirúrgica. Facultad de Enfermería y Terapia Ocupacional. Universidad de ExtremaduraMarina FJ Fontán Jiménez, PhD, Principal investigator, Departamento de Enfermería. Centro Universitario de Plasencia. Universidad de ExtremaduraRaquel MA Raquel Mayordomo Acevedo, PhD, Study director, Departamento de Anatomía, Biología Celular y Zoología. Centro Universitario de Plasencia. Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953401
- Sponsor's protocol ID
- 150425
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activity of the Gastrocnemius and Soleus Muscles During a Specific Contraction Task Assessed by Surface Electromyography
- ClinicalTrials.gov ID
- NCT06953401
- Acronym / sponsor ID
- 150425
- Conditions
- Muscle Activity, Electromyography, Lower Limb
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- Reduced lower limb mobility.
- Neuromuscular or skeletal conditions affecting the calf region.
- Intense physical activity 12 hours before testing.
- Lack of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle contraction protocol for electromyographic assessmentParticipants will perform a set of standardized lower limb muscle contractions (isometric, concentric, and eccentric) involving the gastrocnemius and soleus muscles while lying on an examination table and in standing position both static and dynamic as well as walking. Surface electromyography (mDurance® sEMG system) will be used to record muscle activation during each phase. The task is designed for physiological measurement only and does not constitute a therapeutic intervention. Protocol includes 3 trials per muscle and side, using standardized test conditions. | Other | – |
Primary outcome
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).
4 secondary outcomes
RMS (root mean square) and peak EMG signal values (μV)
Time frame: 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
Activity differences by foot posture (pronated, neutral, supinated)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Victoria CM María Victoria Cáceres Madrid, PhD principal investigator
Departamento de Enfermería. Centro Universitario de Plasencia. Universidad de Extremadura
Olga LR Olga López Ripado, MSc principal investigator
Departamento de Anatomía, Biología Celular y Zoología. Centro Universitario de Plasencia. Universidad de Extremadura
Alejando CP Alejandro Caña Pino, PhD principal investigator
Departamento de Terapéutica Médico-Quirúrgica. Facultad de Enfermería y Terapia Ocupacional. Universidad de Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Activity and Electromyography, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel MA Dra. Raquel Mayordomo Acevedo, PhD (927427000, rmayordo@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activation, microvolts (μV) (time frame: Baseline or Day 1. During a single assessment session (~30 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.