To Assess the Efficacy of a Localized Focal Vibration Too... | NCT06955689

Status Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Non invasive focal vibration with heads	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Rovira i Virgili University		Reus	Tarragona	43202	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31323197	Result	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.
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