Proprioceptive DisordersNCT03871738
Proprioception in the Improvement of Sports Performance in Long Jumpers.
A study testing Proprioceptive training in people with Proprioceptive Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: In jumping sports the tendinopathies of patellar and Achilles tendon are very frequent. Sports performance is the action that optimizes the relationship between physical abilities and the exercise to be performed. Good proprioceptive work favors the correct execution of the technique in jumping sports. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Proprioceptive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 15 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Jumping athletes in length
- Female
- With an age range of 18 to 35 years
- Currently participate in regional and / or national competitions.
Who cannot join
- Not signed the informed consent document
- Practice another sport discipline
- Have some type of medical diagnosis of injury to the lower limb at the time of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of a Proprioception Work in the Improvement of Sports Performance in Long Jumpers. A Randomized Clinical Trial.
Introduction: In jumping sports the tendinopathies of patellar and Achilles tendon are very frequent. Sports performance is the action that optimizes the relationship between physical abilities and the exercise to be performed. Good proprioceptive work favors the correct execution of the technique in jumping sports.
Aim: To evaluate the effectiveness of the lower limb proprioception exercise in the increase of sports performance, in adults and federated long jumpers Study design: Randomized single-blind multicenter study, with follow-up period. Methods: The 139 subjects included in the study will be randomly assigned to the two study groups: experimental (proprioception protocol) and control (non-intervention group). The intervention will be carried out for 4 weeks, with two weekly sessions, lasting 25 minutes. Three evaluations were carried out (baseline, post-intervention and follow-up). The study variables will be: Proprioception (evaluated by the Romberg test and the SEBT), and sports performance (evaluated with vertical, horizontal jump and competition simulation tests). The analysis of normality will be carried out by the Kolmogorov Smirnof test and in the case of homogeneity of the groups, through the t-student test of related measures and an ANOVA of repeated means, we will calculate the difference between the different evaluations and the effect intra and intersubject.
Expected results. To observe improvement in sports performance, once the proprioceptive exercises have been carried out.
- Conditions
- Proprioceptive Disorders
- Being tested
- Proprioceptive training
- Keywords
- Proprioception, Sports performance, Long jump, Physiotherapy, Randomized clinical trial.
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive trainingOther
The intervention to the experimental group will consist of the application of the protocol of proprioception exercises. Before the exercises of the protocol, a warm-up will be carried out that will last 3 minutes and consists of exercises of joint mobility and jumping rope.
The protocol consists in carrying out two exercises per session, of 10 minutes each. A minute of rest will be implemented between the warm-up and the completion of the protocol, in addition to one minute between the two proprioception exercises in each session. The exercises will vary from week to week, and all the protocol exercises should be done barefoot. The exercise protocol proposed in this study consists of a total of 7 exercises: of unipodal and bipodal support, with unstable surfaces and postural changes.
| Study group | Role | What they receive |
|---|---|---|
| Proprioception training | Experimental | The subjects included in the experimental group will carry out a protocol of proprioception exercises. Each session will last 25 minutes, taking place during 2 sessions a week, in a period of 4 weeks. All interventions will be made before the training session. Receives: Other: Proprioceptive training |
| Control | No intervention | The subjects included in the control group will not receive intervention and will continue to carry out their daily life in the same way as they have done up to now. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline jump performance of the athlete after intervenion and at month - length of jump
Using a competition simulator will measure the performance of the athlete, seeking to get as close as possible to the conditions of competition. To carry out this measurement, the athletes will make three full length jumps with approach run of between 14 and 17 steps. Previously, the jumpers will perform their usual warm-up and, between jump and jump, they will have an active rest of 10 minutes. The jump will be measured from the tip of the foot of takeoff, on the board of beaten, to the mark of the sand using a tape measure. The unit of measurement is the centimeter (the greater the distance, the greater the athlete's performance).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (4)
Change from baseline jump performance of the athlete after intervenion and at month - vertical jump test
Through the vertical jump test we will evaluate the jump performance. This measuring instrument has been shown to have high reliability in the measurement of jump performance [ICC = 0.97]. To carry out the evaluation, each subject will perform a practice jump before the test to be measured. The athlete will be placed with both feet resting on the ground, and a shoulder-width apart and a 90º knee flexion, requesting him to make a maximum vertical jump using the arms. The height of the jump will be determined with a tape measure attached to the wall and the chalk mark that the athlete makes in his jump. Each subject will make two jumps and the best score will be chosen for the analysis. The unit of measurement is the centimeter (the greater the distance, the greater the athlete's performance).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline jump performance of the athlete after intervenion and at month - horizontal jump test
Through the horizontal jump test the performance of the athlete will be measured. This measuring instrument has a high intraclass correlation [ICC = 0.93]. The starting position of the athletes will be with both feet resting on the ground, with a shoulder-width apart, following a line marked on the ground. The hands will be placed in neutral position, asking the subjects to make a countermovement with the legs and arms jumping horizontally as much as possible. Finally, they should fall into the sand pit with both feet, registering the horizontal distance between the start line and the heel. The athletes may perform two jumps, being estimated as the value of the evaluation, the best score of both. The unit of measurement is the centimeter (the greater the distance, the greater the athlete's performance).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline proprioception after intervenion and at month - unipodal Romberg test
The unipodal Romberg test is the measuring instrument that will be used for the evaluation of proprioception. It consists of asking the athlete to stand with unipodal support, preferably barefoot and with arms on the sides of the body, maintaining the posture without leaning on their hands. The evaluator, at his side, will be attentive to prevent the athlete from falling due to loss of balance. First you will observe the ability to stay in the position with your eyes open for 5-10 seconds, and if there is postural stability with your eyes open, you will be asked to close your eyes for 20-30 seconds. The unit of measurement of the test is temporary (seconds), indicating a higher score a better proprioception.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline proprioception after intervenion and at month - Star Excusion Balance Test
The Star Excusion Balance Test will be used to evaluate proprioception. This test consists of placing a tape measure on the ground, forming an eight-pointed star, with a 45º separation between them. The patient will be placed with unipodal support in the center of the star, and with the foot in the air you should try to touch as far as possible each line of the star. The evaluator will record the measurement of each line. Each athlete will perform the test three times with each leg, and the evaluator will take the average of those three measurements. The unit of measure is the centimeter, where a greater distance indicates better proprioception.
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 start12 Mar 2019
- Primary completion15 Apr 2019
- Study completion15 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
- 139 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
- NCT03871738
- Sponsor's protocol ID
- PROPIOLJ
- Status last verified
- Jan 2020
- First submitted
- 9 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
- Efficiency of a Proprioception Work in the Improvement of Sports Performance in Long Jumpers. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03871738
- Acronym / sponsor ID
- PROPIOLJ
- Conditions
- Proprioceptive Disorders
- Keywords
- Proprioception, Sports performance, Long jump, Physiotherapy, Randomized clinical trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 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: In jumping sports the tendinopathies of patellar and Achilles tendon are very frequent. Sports performance is the action that optimizes the relationship between physical abilities and the exercise to be performed. Good proprioceptive work favors the correct execution of the technique in jumping sports.
Aim: To evaluate the effectiveness of the lower limb proprioception exercise in the increase of sports performance, in adults and federated long jumpers Study design: Randomized single-blind multicenter study, with follow-up period. Methods: The 139 subjects included in the study will be randomly assigned to the two study groups: experimental (proprioception protocol) and control (non-intervention group). The intervention will be carried out for 4 weeks, with two weekly sessions, lasting 25 minutes. Three evaluations were carried out (baseline, post-intervention and follow-up). The study variables will be: Proprioception (evaluated by the Romberg test and the SEBT), and sports performance (evaluated with vertical, horizontal jump and competition simulation tests). The analysis of normality will be carried out by the Kolmogorov Smirnof test and in the case of homogeneity of the groups, through the t-student test of related measures and an ANOVA of repeated means, we will calculate the difference between the different evaluations and the effect intra and intersubject.
Expected results. To observe improvement in sports performance, once the proprioceptive exercises have been carried out.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioception training | Experimental | Other: Proprioceptive trainingThe subjects included in the experimental group will carry out a protocol of proprioception exercises. Each session will last 25 minutes, taking place during 2 sessions a week, in a period of 4 weeks. All interventions will be made before the training session. |
| Control | No intervention | –The subjects included in the control group will not receive intervention and will continue to carry out their daily life in the same way as they have done up to now. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Jumping athletes in length
- Female
- With an age range of 18 to 35 years
- Currently participate in regional and / or national competitions.
Key exclusion criteria (3 listed)
- Not signed the informed consent document
- Practice another sport discipline
- Have some type of medical diagnosis of injury to the lower limb at the time of study.
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 |
|---|---|---|
| Proprioceptive trainingThe intervention to the experimental group will consist of the application of the protocol of proprioception exercises. Before the exercises of the protocol, a warm-up will be carried out that will last 3 minutes and consists of exercises of joint mobility and jumping rope. The protocol consists in carrying out two exercises per session, of 10 minutes each. A minute of rest will be implemented between the warm-up and the completion of the protocol, in addition to one minute between the two proprioception exercises in each session. The exercises will vary from week to week, and all the protocol exercises should be done barefoot. The exercise protocol proposed in this study consists of a total of 7 exercises: of unipodal and bipodal support, with unstable surfaces and postural changes. | Other | Proprioception training |
Primary outcome
Change from baseline jump performance of the athlete after intervenion and at month - length of jump
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Using a competition simulator will measure the performance of the athlete, seeking to get as close as possible to the conditions of competition. To carry out this measurement, the athletes will make three full length jumps with approach run of between 14 and 17 steps. Previously, the jumpers will perform their usual warm-up and, between jump and jump, they will have an active rest of 10 minutes. The jump will be measured from the tip of the foot of takeoff, on the board of beaten, to the mark of the sand using a tape measure. The unit of measurement is the centimeter (the greater the distance, the greater the athlete's performance).
4 secondary outcomes
Change from baseline jump performance of the athlete after intervenion and at month - vertical jump test
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline jump performance of the athlete after intervenion and at month - horizontal jump test
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline proprioception after intervenion and at month - unipodal Romberg test
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline proprioception after intervenion and at month - Star Excusion Balance Test
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 Proprioceptive 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 jump performance of the athlete after intervenion and at month - length of jump (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.