NCT05757661

Brief Summary

Focal vibration is an adjustable instrument, which has the ability to apply vibration to a specific point at different hertz, powers and rhythms. The use of general or focused vibration is not new in the rehabilitation or sports field. Vibration is intended to stimulate neuromuscular uses to produce involuntary and additional contractions of muscle tissue, indirectly causing an increase in strength or muscle mass , improved fall prevention, mobility and bone consolidation. This type of device has been used both in athletes and in patients with chronic diseases or in intensive care units. There are studies that use vibration in critically ill patients because it is a safe and feasible intervention for dependent patients. One of the advantages of focal vibration is that it can be used in both unloading and loading, which allows a wide range of adaptation to each patient, even simultaneously during a training activity. The aim of the present study is to evaluate the effectiveness of a focal vibration treatment on strength, jumping and running speed in national federated athletes who perform sprinting and jumping in their sports practice. A sample will be recruited during the months of April to September, estimating a sample of 70 total subjects (35 subjects in the vibration group and 35 subjects in the vibration placebo group). Patients will receive a single treatment and assessments will be performed on the same day. The focal vibration group will receive a 30-minute quadriceps intervention. 3 channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The vibration program configuration will be in an automatic mode of 10 seconds of vibration 3 seconds of rest to avoid mechanoreceptor coupling. The frequency used will be between 60 Hz to 150 Hz with a power of 80%. The placebo group will perform the same treatment as the intervention group but without the focal vibration head contacting the skin (placebo). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin as shown in previous studies. A V-Plus machine (Wintecare S.A.) will be used for the vibration treatment. For the assessment measurements, a surface electromyograph, a force measurement dynamometer, the MyJump2 application for jump assessment and two photoelectric cells for sprint measurement will be used.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 23, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

February 23, 2023

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in 30 meters sprint (seconds)

    Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in electromyographic activity during sprint (μ/v)

    The mean electromyographic activity of the quadriceps musculature during sprint will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

Secondary Outcomes (4)

  • Countermovement jump (cm)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in electromyographic activity during countermovement jump (μ/v)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in isometric leg extension (Newtons)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in electromyographic activity during isometric leg extension (μ/v)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

Study Arms (2)

Focal Vibration Group

EXPERIMENTAL
Other: Focal Vibration

Sham Group

SHAM COMPARATOR
Other: Sham Group

Interventions

A single 30-minute focal vibration procedure will be performed on both quadriceps with the V-Plus Wintecare® machine. Three channels will be used on the muscle bellies of the rectus anterior, vastus internus and vastus externus. The positioning of the vibration heads will be done with straps designed by the manufacturer to keep the vibration focus stable on the muscle belly. The configuration of the vibration program will be in an automatic mode of 10 seconds of vibration and 3 seconds of rest to avoid the coupling of the mechanoreceptors. The frequency used will be between 60 Hz to 150 Hz with a power of 80%.

Focal Vibration Group

The same procedure of the intervention group will be performed but without the focal vibration head contacting the skin (sham). A sufficient space will be left between the head and the headgear so that the vibration does not touch the skin.

Sham Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes between 18 and 30 years of age (athletics and field sports such as soccer, basketball, rugby... that may involve sprinting) federated and competing in university or national amateur leagues that perform sprinting and jumping in their sports practice.
  • Active participation in regional, national or international competitions.

You may not qualify if:

  • Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
  • Not understanding the information provided by the therapist.
  • Participate in other research studies.
  • Being under a pharmacological medical treatment that may interfere with the measures, such as treatment with anticonvulsants, antidepressants, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 7, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

March 7, 2023

Record last verified: 2023-02

Locations