Proprioceptive DisordersNCT03870321
Core Training to Improve Abdominal Strength Strength and Ankle Proprioception in Basketball Players
A study testing Core training in people with Proprioceptive Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. The prevalence of ankle injuries in basketball are high. The lack of balance in the ankle is one of the main causes that produces these injuries. The goal of core training is to increase the physical capacities of resistance strength in the abdomen and analyze if it produces improvement in proprioception… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Core training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Basketball players
- Federated in the Community of Madrid
- Male
- With an age range of 18 to 40 years.
Who cannot join
- Who have a musculoskeletal injury at the time of the study or who have suffered a lower limb injury in a period of three months before the study
- That they are in an individualized personal training
- Not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Core Training to Improve Abdominal Strength Strength and Analyze Whether it Provides Improvement in Ankle Proprioception in Federated Basketball Players From 18 to 40 Years: A Pilot Study
Introduction. The prevalence of ankle injuries in basketball are high. The lack of balance in the ankle is one of the main causes that produces these injuries. The goal of core training is to increase the physical capacities of resistance strength in the abdomen and analyze if it produces improvement in proprioception in the ankle joint in basketball players.
Objective. To evaluate the effectiveness of Core training to improve the strength of the abdomen and analyze if it produces improvement in proprioception in ankle of basketball players.
Read more
Study design. Randomized, multicentric, single-blind clinical study with a follow-up period.
Methods. The 30 participants recruited will be randomly assigned to the two study groups: experimental (Core training for strength in the abdomen) and control (without intervention). The treatment will last 4 weeks, with 3 weekly sessions, approximately 20 minutes each. There will be three evaluations (pre-intervention, post-intervention and follow-up). On the dependent variables: strength core resistance (evaluated with Trunk Flexor Test, Trunk Extender Test, and Side Bridge Test) and proprioception (measured with the Star Excursion Balance tests and Romberg test) With the Kolmogorov Smirnov statistical test we will calculate the normality and with the t-student test of paired data and an ANOVA of repeated measures, we will obtain the difference between the three evaluations and the intra and intersubject effect, respectively.
Expected results. To observe improvement in strength in the abdomen and analyze if it produces improvement in proprioception in the ankle of basketball players.
- Conditions
- Proprioceptive Disorders
- Being tested
- Core training
- Keywords
- Core, Strength, Proprioception, Ankle, Basketball
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core trainingOther
In the first week different types of abdominal exercises will be performed: standard, with trunk rotation, extension of the back raising the upper extremity of the body and legs, extension of the back raising one arm and the contralateral leg. In the same way, the subject will raise from the quadruped position one arm and the contralateral leg on each side, and we will ask for the exercise of the front plate, positioning itself in a position of four support points: feet and elbows. When performing the rear bridge exercise the subject will raise the trunk resting on both feet, while in the lateral bridge exercise will be done with support on the right and left side. All exercises will be done for 30 seconds, in 3 series).
During the next three weeks we will continue with the same training, but for each week we will increase 10 seconds per exercise.
| Study group | Role | What they receive |
|---|---|---|
| Core training | Experimental | The subjects who are in the experimental group will carry out the Core training routine Receives: Other: Core training |
| Control | No intervention | The subjects who are in the control group will not receive intervention and will continue with their daily routine and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ankle proprioception after intervention and at month
The Star excursion balance test will be used to measure ankle proprioception. It begins with a star drawn on the ground, while the subject will remain in a static position, placing his or her bare foot in the center of the star. During the execution of the test the subject will be asked to touch the farthest point possible with the tip of the first finger. The contact of the finger has to be clean, without supporting the weight or imbalance of the other foot, returning each time to the initial monopodal position. At each attempt the contact point will be recorded on the ground line. This exercise will be repeated three times and the average of the evaluations will be taken into account to obtain the value of the measurement in each one of the directions to be studied, with the final result being the average distance of all the attempts in each of the directions. The unit of measurement is the centimeter (the greater distance in centimeters, the better ankle proprioception).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (4)
Change from baseline strength of the flexor muscles of the abdomen after intervention and at month
The Trunk Flexor Test will be used to measure the strength of the flexor muscles of the abdomen. The subject will be sitting on a bench, with knees and hips bent at 90 degrees and feet tied to the stretcher. The arms should be crossed over the chest and trunk in a flared position at 60 degrees. The subject must maintain that position as long as possible. The test is terminated when the participant can not sustain the initial position. The unit of measure is temporary (seconds). The greater the amount of time, the greater the strength of the flexor muscles of the abdomen.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline strength of the extensor muscles of the abdomen after intervention and at month
Researchers will use the Trunk Extender Test to evaluate the strength of the extensor muscles of the abdomen. The athlete will be placed in prone position, with the pelvis and ankles fixed to the stretcher with a strap, with the navel on the edge of the stretcher. A chair should be placed at the same height as the stretcher to support the trunk and upper extremity. Then the chair will be removed and the subject should maintain a horizontal position with arms crossed to the trunk as long as possible. The test ends when the subject can not hold the initial position anymore and touch the chair in front of them with their hands. The unit of measure is temporary (seconds). The greater the amount of time, the greater the strength of the extensor muscles of the abdomen.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline strength of the lateral flexor muscles of the abdomen after intervention and at month
The Side Bridge Test will be used to measure the strength of the lateral flexor muscles of the abdomen. The subject will be placed in the lateral decubitus with the knees extended on the stretcher being asked to lift the hip of the stretcher using only the feet and the elbow as support. The test will end when the hip falls. The unit of measure is temporary (seconds). The greater the amount of time, the greater the strength of the lateral flexor muscles of the abdomen.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline ankle proprioception after intervention and at month
The Romberg test will be used to measure proprioception. The athlete will be asked to stand with their feet together, their arms loose on their sides and their eyes open. In this position any imbalance will be recorded and subsequently you will be asked to close your eyes. The stability will be observed and it will be compared with the one presented with the eyes open. The degree of oscillation and the direction of hips, knees and the entire body should be evaluated. The test is considered positive if there is an imbalance or if the oscillation worsens significantly with the closing of the eyes (score 1). Otherwise, it will be negative (score 0).
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 posted12 Mar 2019
- Study start1 Apr 2019
- Primary completion15 May 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 Proprioceptive DisordersStudies 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
- NCT03870321
- Sponsor's protocol ID
- Strength
- Status last verified
- Jan 2020
- First submitted
- 8 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Efficacy of Core Training to Improve Abdominal Strength Strength and Analyze Whether it Provides Improvement in Ankle Proprioception in Federated Basketball Players From 18 to 40 Years: A Pilot Study
- ClinicalTrials.gov ID
- NCT03870321
- Acronym / sponsor ID
- Strength
- Conditions
- Proprioceptive Disorders
- Keywords
- Core, Strength, Proprioception, Ankle, Basketball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 12 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 prevalence of ankle injuries in basketball are high. The lack of balance in the ankle is one of the main causes that produces these injuries. The goal of core training is to increase the physical capacities of resistance strength in the abdomen and analyze if it produces improvement in proprioception in the ankle joint in basketball players.
Objective. To evaluate the effectiveness of Core training to improve the strength of the abdomen and analyze if it produces improvement in proprioception in ankle of basketball players.
Study design. Randomized, multicentric, single-blind clinical study with a follow-up period.
Methods. The 30 participants recruited will be randomly assigned to the two study groups: experimental (Core training for strength in the abdomen) and control (without intervention). The treatment will last 4 weeks, with 3 weekly sessions, approximately 20 minutes each. There will be three evaluations (pre-intervention, post-intervention and follow-up). On the dependent variables: strength core resistance (evaluated with Trunk Flexor Test, Trunk Extender Test, and Side Bridge Test) and proprioception (measured with the Star Excursion Balance tests and Romberg test) With the Kolmogorov Smirnov statistical test we will calculate the normality and with the t-student test of paired data and an ANOVA of repeated measures, we will obtain the difference between the three evaluations and the intra and intersubject effect, respectively.
Expected results. To observe improvement in strength in the abdomen and analyze if it produces improvement in proprioception in the ankle of basketball players.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core training | Experimental | Other: Core trainingThe subjects who are in the experimental group will carry out the Core training routine |
| Control | No intervention | –The subjects who are in the control group will not receive intervention and will continue with their daily routine and training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Basketball players
- Federated in the Community of Madrid
- Male
- With an age range of 18 to 40 years.
Key exclusion criteria (3 listed)
- Who have a musculoskeletal injury at the time of the study or who have suffered a lower limb injury in a period of three months before the study
- That they are in an individualized personal training
- Not signed the informed consent document.
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 |
|---|---|---|
| Core trainingIn the first week different types of abdominal exercises will be performed: standard, with trunk rotation, extension of the back raising the upper extremity of the body and legs, extension of the back raising one arm and the contralateral leg. In the same way, the subject will raise from the quadruped position one arm and the contralateral leg on each side, and we will ask for the exercise of the front plate, positioning itself in a position of four support points: feet and elbows. When performing the rear bridge exercise the subject will raise the trunk resting on both feet, while in the lateral bridge exercise will be done with support on the right and left side. All exercises will be done for 30 seconds, in 3 series). During the next three weeks we will continue with the same training, but for each week we will increase 10 seconds per exercise. | Other | Core training |
Primary outcome
Change from baseline ankle proprioception after intervention and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The Star excursion balance test will be used to measure ankle proprioception. It begins with a star drawn on the ground, while the subject will remain in a static position, placing his or her bare foot in the center of the star. During the execution of the test the subject will be asked to touch the farthest point possible with the tip of the first finger. The contact of the finger has to be clean, without supporting the weight or imbalance of the other foot, returning each time to the initial monopodal position. At each attempt the contact point will be recorded on the ground line. This exercise will be repeated three times and the average of the evaluations will be taken into account to obtain the value of the measurement in each one of the directions to be studied, with the final result being the average distance of all the attempts in each of the directions. The unit of measurement is the centimeter (the greater distance in centimeters, the better ankle proprioception).
4 secondary outcomes
Change from baseline strength of the flexor muscles of the abdomen after intervention and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline strength of the extensor muscles of the abdomen after intervention and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline strength of the lateral flexor muscles of the abdomen after intervention and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline ankle proprioception after intervention 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.
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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 Core training in people with Proprioceptive Disorders, 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 4 inclusion and 3 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 ankle proprioception after intervention 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.