StabilityNCT03866096
Neuromuscular Training and Strengthening CORE in Volleyball Amateur Players 18 to 25 Years
A study testing Experimental in people with Stability, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stability
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2019to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volleyball players
- Female
- From 18 to 25 years
- With more than one year of sports practice
- Currently participate in amateur industry competitions
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Training and Strengthening CORE Front of a Neuromuscular Training on Improvement of Knee Stability, Balance and Power in the Vertical Jump in Volleyball Amateur Players. A Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Stability
- Being tested
- Experimental, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Neuromuscular training and strengthening of CORE
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
ControlOther
Also called Neuromuscular training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start8 Mar 2019
- Primary completion20 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866096
- Sponsor's protocol ID
- ENCORE
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Training and Strengthening CORE Front of a Neuromuscular Training on Improvement of Knee Stability, Balance and Power in the Vertical Jump in Volleyball Amateur Players. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03866096
- Acronym / sponsor ID
- ENCORE
- Conditions
- Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalEach 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 |
| Control | Active comparator | Other: ControlEach 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volleyball players
- Female
- From 18 to 25 years
- With more than one year of sports practice
- Currently participate in amateur industry competitions
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: Neuromuscular training and strengthening of COREThe 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 | Other | Experimental |
| ControlAlso: Neuromuscular trainingNeuromuscular 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. | Other | Control |
Primary outcome
Change from baseline the balance after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
2 secondary outcomes
Change from baseline vertical jump power after treatment and at month
Time frame: 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
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Stability, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline the balance after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.