NCT03866096

Brief Summary

Introduction. The most popular injuries in volleyball are the ones who occur in knee joints, due the jumps and landings that happen through the game. For this reason there is a high index of loss of stability because of the dynamic valgus during the landing, a loss of balance and a decrease of power during the jumps. Objective. Evaluate the effectiveness of neuromuscular training in combination with strengthening of CORE in the improvement of knee joint stability, balance and power in vertical jump in volleyball players from 18 to 25 years old. Study design. Randomized, multicenter, single-blind clinical study with follow-up period. Methods. The study will be realized with an initial sample of 30 players, which in a random way, will be divided into two groups: experimental and control. It will be realized an initial evaluation where sociodemographic, anthropometric and clinical measures will be taken, and the study variables: knee joint stability (single leg squat test), balance (star excursion balance test) and vertical jump (sargent jump test). The intervention will last six weeks, with two sessions per week of approximately twenty minutes each. Expected results. The investigators expected to observe improvement in the stability in the knee joint, balance and power in the vertical jump in 18-25 years volleyball players that have received a neuromuscular training with strengthening of CORE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 4, 2019

Last Update Submit

January 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline the balance after treatment and at month

    Through the Star Excursion Balance test the balance will be assessed, observing the distance (in centimeters) that the subject manages to reach with the unsupported foot. During the test, the player will be placed in standing position performing a monopodal support, asking her to direct the leg that is not supported in the directions: anterior, posterolateral and posteromedial previously drawn on the floor with tape. The evaluator will mark the maximum distance achieved, without moving the support foot and without touching the ground with the reach foot, the subject should not fail when returning the reach foot to the starting position. The greater distance (cm) the better balance. The best of the three attempts made will be taken as a valid measure.

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (2)

  • Change from baseline vertical jump power after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline joint stability of the knee after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Experimental

EXPERIMENTAL

Each session will last 20 minutes, taking place during 2 days a week, in a period of 6 weeks. The intervention will be made prior to the training session. The subjects of the experimental group will receive an intervention through neuromuscular training and a CORE strengthening program

Other: Experimental

Control

ACTIVE COMPARATOR

Each session will last 20 minutes, taking place during 2 days a week, in a period of 6 weeks. The intervention will be made prior to the training session. The subjects of the experimental group will receive an intervention through neuromuscular training.

Other: Control

Interventions

The player will perform exercises of balance, stability, and strengthening of the abdomen, back and gluteus. All these exercises will be carried out in first instance on flat surfaces and later on unstable surfaces to increase the difficulty of it. The training will be done in different levels of difficulty, once the participant managed to master the initial level, advance to the next level to complete the three levels of difficulty during the 6 weeks of training. There will be 3 repetitions of each exercise with a duration of one minute and breaks of 30 seconds between each repetition and 2 minutes of rest between exercises. The duration of the intervention of the experimental group will last 20 minutes

Also known as: Neuromuscular training and strengthening of CORE
Experimental
ControlOTHER

Neuromuscular training will be applied through balance and stability exercises on both flat and unstable surfaces. There will be 3 repetitions of each exercise with a duration of one minute and breaks of 30 seconds between each repetition and 2 minutes of rest between exercises. The duration of each session of the control group is 10 minutes.

Also known as: Neuromuscular training
Control

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volleyball players
  • Female
  • From 18 to 25 years
  • With more than one year of sports practice
  • Currently participate in amateur industry competitions

You may not qualify if:

  • Present a medical diagnosis of musculoskeletal injury at the time of beginning the study
  • Receive a physiotherapy treatment unrelated to the study
  • Have suffered neurological pathology in the last 6 months
  • Have some type of auditory or vestibular disorder
  • Not signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 7, 2019

Study Start

March 8, 2019

Primary Completion

April 20, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations