NCT06953401

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2025

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle activation, microvolts (μV)

    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 Outcomes (4)

  • RMS (root mean square) and peak EMG signal values (μV)

    Baseline or Day 1. During the same assessment session

  • Differences in muscle activity by contraction type (μV)

    Baseline or Day 1. Immediately after the execution of each contraction type during the session

  • Activity differences by foot posture (pronated, neutral, supinated)

    Baseline or Day 1. Immediately after foot posture assessment during the same session

  • Correlation with physical activity level Physical Activity Questionnaire (IPAQ-short version)

    Baseline or Day 1. Collected at baseline before EMG assessment

Interventions

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.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitario de Plasencia

Plasencia, Cáceres, 10600, Spain

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Raquel MA Raquel Mayordomo Acevedo, PhD

    Departamento de Anatomía, Biología Celular y Zoología. Centro Universitario de Plasencia. Universidad de Extremadura

    STUDY DIRECTOR

Central Study Contacts

Raquel MA Dra. Raquel Mayordomo Acevedo, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 1, 2025

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations