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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03866096
Other study ID # ENCORE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2019
Est. completion date June 20, 2019

Study information

Verified date January 2020
Source Investigación en Hemofilia y Fisioterapia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 20, 2019
Est. primary completion date April 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Volleyball players

- Female

- From 18 to 25 years

- With more than one year of sports practice

- Currently participate in amateur industry competitions

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental
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
Control
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.

Locations

Country Name City State
Spain Universidad Europea de Madrid Madrid Comunity Of Madrid

Sponsors (1)

Lead Sponsor Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline vertical jump power after treatment and at month Through the Sargent Jump test the vertical jump power will be evaluated, measuring the maximum height (in centimeters) reached during the vertical jump. To perform the test, a tape measure attached to a wall will be placed to measure the height reached. Giving a chalk to the subject so that, from the standing position, lateral to the belt, and with the right arm extended on the head, mark the place where the tips of your fingers reach without lifting the heels of the ground. Once the mark is made, you will be asked to perform the vertical jump, bending the knees, with the left arm attached to the body and the right arm extended over the head. Once in the air, the subject must mark the maximum height obtained on the measuring tape with his fingers. The height of the jump is the difference between the two marks in the tape measure, taking as final value the best of the three jumps, leaving between jump and jump a break of 45 seconds Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Change from baseline joint stability of the knee after treatment and at month Through the Single Leg Squat test the joint stability of the knee will be evaluated, asking the subject to, barefoot, place his hands on the hip, and perform a unipodal squat up to 90 degrees. The participants will perform the test 3 times in a row with each leg. The evaluator will observe any abnormal response that occurs during the performance of the test (shake arms, Trendelenburg sign or valgus or varus support knee collapse). The result will be positive if the participant gets more than two thirds of the abnormal responses in each leg. Screening visit, within the first seven days after treatment and after one month follow-up visit
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