Prevention and ControlEVIFOBIOMINCT06955689
To Assess the Efficacy of a Localized Focal Vibration Tool on the Muscular Response to Five Countermovement Jumps in Healthy Soccer Players
A study testing Non invasive focal vibration with heads and Non invasive focal vibration without heads in people with Prevention and Control and Healthy People Programs, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention and Control, Healthy People Programs
- What is being tested?
- Non invasive focal vibration with heads and Non invasive focal vibration without heads
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Prevention and Control, Healthy People Programs
- Being tested
- Non invasive focal vibration with heads, Non invasive focal vibration without heads
- Keywords
- vibration, biomechanics, lower extremity, football, plyometric exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive focal vibration with headsOther
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
Non invasive focal vibration without headsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Other: Non invasive focal vibration with heads |
| Placebo group | Placebo comparator | 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. Receives: Other: Non invasive focal vibration without heads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heigh of countermovement jump with G-sensor
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.
Measured: From enrollment to the end of treatment at 3 weeks"
Secondary outcomes (3)
Muscle electrical activity with surface electromyography
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.
Measured: From enrollment to the end of treatment at 3 weeks"
Velocity of countermovement jump with G-sensor
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.
Measured: From enrollment to the end of treatment at 3 weeks"
Power of countermovement jump with G-sensor
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.
Measured: From enrollment to the end of treatment at 3 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start2 Jan 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prevention and ControlStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gisela Cisa Ribas, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955689
- Sponsor's protocol ID
- 195/2021
- Acronym
- EVIFOBIOMI
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li W, Li C, Xiang Y, Ji L, Hu H, Liu Y. Study of the activation in sensorimotor cortex and topological properties of functional brain network following focal vibration on healthy subjects and subacute stroke patients: An EEG study. Brain Res. 2019 Nov 1;1722:146338. doi: 10.1016/j.brainres.2019.146338. Epub 2019 Jul 16.
PubMed 31323197Brunetti O, Botti FM, Brunetti A, Biscarini A, Scarponi AM, Filippi GM, Pettorossi VE. Effects of focal vibration on bone mineral density and motor performance of postmenopausal osteoporotic women. J Sports Med Phys Fitness. 2015 Jan-Feb;55(1-2):118-27.
PubMed 25642687Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
PubMed 24842220Cisa-Ribas G, Perez SM. Effect of Focal Vibration Technique on Lower Limb Performance: A Randomized, Double-Blind Study. J Orthop Res. 2026 Mar;44(3):e70178. doi: 10.1002/jor.70178.
PubMed 41819813
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Localized Focal Vibration Tool on the Biomechanics of the Lower Limb
- ClinicalTrials.gov ID
- NCT06955689
- Acronym / sponsor ID
- EVIFOBIOMI / 195/2021
- Conditions
- Prevention and Control, Healthy People Programs
- Keywords
- vibration, biomechanics, lower extremity, football, plyometric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 2 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Non invasive focal vibration with headsThe 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. |
| Placebo group | Placebo comparator | Other: Non invasive focal vibration without headsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Non invasive focal vibration with heads3 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 | Other | Intervention group |
| Non invasive focal vibration without heads3 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 | Other | Placebo group |
Primary outcome
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.
3 secondary outcomes
Muscle electrical activity with surface electromyography
Time frame: 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"
Power of countermovement jump with G-sensor
Time frame: From enrollment to the end of treatment at 3 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Results publication: PubMed 31323197Li W, Li C, Xiang Y, Ji L, Hu H, Liu Y. Study of the activation in sensorimotor cortex and topological properties of functional brain network following focal vibration on healthy subjects and subacute stroke patients: An EEG study. Brain Res. 2019 Nov 1;1722:146338. doi: 10.1016/j.brainres.2019.146338. Epub 2019 Jul 16.
- Results publication: PubMed 25642687Brunetti O, Botti FM, Brunetti A, Biscarini A, Scarponi AM, Filippi GM, Pettorossi VE. Effects of focal vibration on bone mineral density and motor performance of postmenopausal osteoporotic women. J Sports Med Phys Fitness. 2015 Jan-Feb;55(1-2):118-27.
- Results publication: PubMed 24842220Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
- Derived from this study: PubMed 41819813Cisa-Ribas G, Perez SM. Effect of Focal Vibration Technique on Lower Limb Performance: A Randomized, Double-Blind Study. J Orthop Res. 2026 Mar;44(3):e70178. doi: 10.1002/jor.70178.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive focal vibration with heads and Non invasive focal vibration without heads in people with Prevention and Control and Healthy People Programs, run by University Rovira i Virgili 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 2 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: finished, as of the sponsor's last update on 2 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heigh of countermovement jump with G-sensor (time frame: From enrollment to the end of treatment at 3 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955689, which also lists 4 linked publications.
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 2 May 2025.