To Assess the Efficacy of a Localized Focal Vibration Tool on the Muscular Response to Five Countermovement Jumps in Healthy Soccer Players (EVIFOBIOMI)

April 24, 2025 updated by: Gisela Cisa Ribas, University Rovira i Virgili

Effectiveness of the Localized Focal Vibration Tool on the Biomechanics of the Lower Limb

This research study aims to introduce the localized focal vibration tool. To this end, a 3-week protocol with a single session per week was created.

In the one hand, the study subject must be a soccer player, regardless of whether male or female, and must not be suffering from any active injury.

All subjects must complete an identical warm-up before beginning the noninvasive intervention using the vibration tool.

The warm-up consists of various joint mobility exercises for the legs, a brief cardio session by pedaling a stationary bicycle, and finally, jumping exercises to properly activate the main muscles of the lower limbs and thus be able to begin the intervention protocol.

In the other hand, the study subjects are divided into two groups: intervention and placebo.

Neither the study subject nor the research team knows who belongs to each group; only the person handling the focal vibration tool will know.

To begin the intervention, three surface electromyography probes are placed on the vastus medialis of the quadriceps, the tibialis anterior, and the internal gastrocnemius, and the subject is asked to perform five countermovement jumps barefoot and without moving their arms to gain momentum.

The subject then pedals at 90-100 rpm on a stationary bicycle while wearing the sensors of the 120 Hz focal vibration tool for 10 minutes.

The intervention group wears headgear to ensure tactile stimulation, while the placebo group does not wear headgear, thus ensuring that there is no tactile stimulation.

After the pedaling period, the electromyography sensors are reapplied to the lower limb in the anatomical areas described above, and the same jumping protocol is followed again.

This intervention is identical for the 3 days of recording.

This noninvasive intervention protocol aims to demonstrate the effectiveness of the 120 Hz focal vibration tool in recruiting muscle fibers in the targeted muscles through numerical improvements in muscle electrical activity and improved countermovement jump parameters.

A three-day follow-up period was established to determine when any improvement from the application of focal vibration therapy begins.

All study subjects are volunteers to participate during the official soccer season for their respective age group and may withdraw from the study at any time if they wish.

Study Overview

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

    • Tarragona
      • Reus, Tarragona, Spain, 43202
        • Rovira i Virgili University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Practice soccer at least three times a week.
  • Do not suffer from any alterations or pathologies prior to or during the study in the area of interest for the research.

Exclusion Criteria:

  • Having a lower limb disorder or pathology
  • Receiving any type of lower limb treatment from a healthcare professional or receiving pseudoscientific treatments.
  • Having any absolute or relative contraindications to measurement tests, surface electromyography, inertial sensor, and/or focal vibration.
  • Refuse to sign 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group

The intervention group performed a 20-minute warm-up divided into four equal parts. First, they performed lower limb joint mobility exercises, followed by pedaling a stationary bicycle at 60-70 rpm. They then performed specific plyometric exercises for jumping and 8 minutes of active rest.

After completing the warm-up, the subjects performed five countermovement jumps. They were then fitted with focal vibration devices with the heads set at 120 Hz, while they pedaled for 10 minutes at 90-100 rpm. Once the time was up, they performed the five countermovement jumps again.

The protocol was identical for all three days of the intervention.

3 sessions over 3 consecutive weeks, with one intervention day per week. Non invasive focal vibration at 120 Hz for 10 minutes while pedaling at 90-100 rpm
Placebo Comparator: Placebo group

The placebo group performed a 20-minute warm-up divided into four equal parts. They first performed lower limb joint mobility exercises, followed by pedaling a stationary bicycle at 70-80 rpm. They then performed specific plyometric exercises for jumping and 8 minutes of active rest.

After completing the warm-up, the subjects performed five countermovement jumps. They were then fitted with the focal vibration devices without the headpieces, so as not to produce any tactile stimulation, at 0 Hz, while they pedaled for 10 minutes at 90-100 rpm. Once the time was up, they performed the five countermovement jumps again.

The protocol was identical for all three days of the intervention.

3 sessions over 3 consecutive weeks, with one intervention day per week. Non invasive focal vibration at 0 Hz for 10 minutes while pedaling at 90-100 rpm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heigh of countermovement jump with G-sensor
Time Frame: From enrollment to the end of treatment at 3 weeks"
Average height of the second sacral vertebra difference of the 5 countermovement jumps over the 3 days of intervention. This difference is evaluated using the inertial G sensor on the second sacral vertebra. It is a device that is placed on the subject's waist, secured with a belt, in order to measure the difference in jump height in centimeters.
From enrollment to the end of treatment at 3 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle electrical activity with surface electromyography
Time Frame: From enrollment to the end of treatment at 3 weeks"
The difference in muscle electrical activation of the following muscles is evaluated: Vastus medialis of the quadriceps, Tibialis anterior and Gastrocnemius medialis, of the dominant lower extremity in the five countermovement jumps over the 3 days of intervention. The electromyographic values, in millivolts, are obtained using the FREEMG 1000 tool.
From enrollment to the end of treatment at 3 weeks"
Velocity of countermovement jump with G-sensor
Time Frame: From enrollment to the end of treatment at 3 weeks"
Average velocity of the second sacral vertebra difference of the 5 countermovement jumps over the 3 days of intervention. This difference is evaluated using the inertial G sensor. It is a device that is placed on the subject's waist, secured with a belt, in order to measure the difference values of the velocity in meters/seconds.
From enrollment to the end of treatment at 3 weeks"
Power of countermovement jump with G-sensor
Time Frame: From enrollment to the end of treatment at 3 weeks"
Average to power difference of the 5 countermovement jumps over the 3 days of intervention. This difference is evaluated using the inertial G sensor on the second sacral vertebra. It is a device that is placed on the subject's waist, secured with a belt, in order to measure the difference values of the power in Watts.
From enrollment to the end of treatment at 3 weeks"

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 2, 2022

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 195/2021

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

product manufactured in and exported from the U.S.

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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