NCT06955689

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

April 9, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

vibrationbiomechanicslower extremityfootballplyometric exercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of treatment at 3 weeks"

Secondary Outcomes (3)

  • Muscle electrical activity with surface electromyography

    From enrollment to the end of treatment at 3 weeks"

  • Velocity of countermovement jump with G-sensor

    From enrollment to the end of treatment at 3 weeks"

  • Power of countermovement jump with G-sensor

    From enrollment to the end of treatment at 3 weeks"

Study Arms (2)

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.

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.

Other: Non invasive focal vibration without heads

Interventions

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

Intervention group

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

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rovira i Virgili University

Reus, Tarragona, 43202, Spain

Location

Related Publications (3)

  • 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.

    PMID: 31323197BACKGROUND
  • Brunetti 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.

    PMID: 25642687BACKGROUND
  • Murillo 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.

    PMID: 24842220BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 9, 2025

First Posted

May 2, 2025

Study Start

January 2, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations