RugbyNCT03865797
Core Work and Sports Bandage in Rugby Players
A study testing Experimental in people with Rugby, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. Lower limb injuries are characteristic of rugby players. Core exercises aim to improve ankle stability. The ankle bandage in 8 is used in the approach to injuries to provide better stability in the joint. Objectives. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Rugby
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 8 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Rugby players
- Both gender
- From 18 to 40 years old
- Federated.
Who cannot join
- At the time of the study, they present an injury that prevents them from carrying out the proposed intervention
- Included in a personal training regime
- With musculoskeletal injuries in the ankle in the last 3 months
- Not sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Core Work and Sports Bandage to Improve Ankle Instability in Rugby Players: A Pilot Study
Introduction. Lower limb injuries are characteristic of rugby players. Core exercises aim to improve ankle stability. The ankle bandage in 8 is used in the approach to injuries to provide better stability in the joint.
Objectives. To assess the effectiveness of an intervention through motor control and bandage on lower limb stability in rugby players from 18 to 40 years old.
Read more
Study design. Randomized, single-blind clinical study with a follow-up period. Methodology. Twenty-five rugby players will be recruited to be randomized to the two study groups: experimental (specific exercises for the Core area and ankle bandage) and control (Core motor control). The intervention will last 4 weeks, with 2 weekly sessions of 15min each. The study variables will be: core motor control (measured with plate test, trunk flexion test and modified Biering-Sorensen test) and the stability of the lower limbs (measured with Double Heel Rise and Single Heel Rise test). A descriptive analysis will be carried out calculating the main statistical characteristics. Through an analysis of Shapiro-Wills the normality of the study groups will be calculated, and through an analysis with the parametric tests of t-student and ANOVA of repeated measures, we will evaluate the difference after the evaluations in both groups and the intra-e intersubject, respectively.
Expected results. Increased motor control of the core and stability of lower limbs.
- Conditions
- Rugby
- Being tested
- Experimental, Control active
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Ankle stability
Each session will last approximately 15 minutes, taking place during 2 days a week, in a period of 4 weeks. The intervention will be done before the training session. The intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up.The intervention will be done before the training session.
Control activeOther
Also called Ankle stability
Each session will last approximately 15 minutes, taking place during 2 days a week, in a period of 4 weeks. The intervention will be done before the training session. The intervention by motor control will consist of the application of a series of Core exercises. The objective of the application of these exercises is to increase the control of the Core, and therefore improve the stability both central and of members. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises (13) will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Before carrying out each session of the intervention, each subject included in the experimental group will have a sports bandage on both ankles. The intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up. The duration of each session will be 15 minutes, with two sessions per week, during a period of 4 weeks. Receives: Other: Experimental |
| Control | Active comparator | The intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up. The duration of each session will be 15 minutes, with two sessions per week, during a period of 4 weeks. Receives: Other: Control active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline central stability after treatment and at month
The assessment of the central stability will be carried out with the modified Biering-Sorensen test. The subject must remain prone on a stretcher, while the part of the trunk should protrude through the front of the stretcher and completely parallel to the floor. The arms will remain crossed on the chest touching the shoulders at all times. The test ends when the subject supports any part of his body on the floor. The normative values of this test are 146 seconds for men and 189 for women, with the second being the unit of measurement for this test.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (4)
Change from baseline Core rating after treatment and at month
By means of the lateral plate test, which is a test adapted from the exercise of the side plate, we will evaluate the Core. The subject will be placed in lateral decubitus with the elbow resting on the floor, asking him to raise the hip and remain static for the established time. The most characteristic modification is the crossing of the arm in front of the trunk to touch the shoulder of the arm that is in contact with the ground. The unit of measurement is of time (in seconds). The normative values of lumbopelvic stability in men range from 94 to 97 seconds, being in women from 72 to 77 seconds.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline trunk strength after treatment and at month
By means of the isometric trunk flexion test the trunk force will be measured in a situation similar to the sit up, but without movement. The subject will be placed in the supine position, with the knees bent and feet grasped by the assessor or by straps, but with a trunk flexion at 60 degrees (a square can be used for its concretion). The test will end when this angle varies, with the unit of measurement being the second. The normative value range is 149 to 144 seconds.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline ankle stability after treatment and at month
The stability of the ankle will be measured with the Double Heel Rise test, which consists of asking the athlete to stand on tiptoe with both feet at the same time and the evaluator will measure the calcaneus of the foot. If, on tiptoe, the calcaneus does not change its position from valgus to varus (rearward projection to supinated hindfoot), it means that the posterior tibial muscle is not in good condition. However, when the player's heel changes its position from valgus to varus, the test will be negative and the posterior tibial will be in good condition.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline ankle stability after treatment and at month
The stability of the ankle will be measured with the Single Heel Rise test, which consists in requesting the athlete to stand on tiptoe only with the foot to be evaluated, while the evaluator will measure the calcaneus bone of the foot. If, on tiptoe, the calcaneus does not change its position from valgus to varus (rear right to backward supinated), it means that the posterior tibial muscle of that leg is not in good condition. However, when the player's heel changes its position from valgus to varus, the test will be negative and the posterior tibial will be in good condition.
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 completion10 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 RugbyStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865797
- Sponsor's protocol ID
- AZul
- 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
- Effectiveness of Core Work and Sports Bandage to Improve Ankle Instability in Rugby Players: A Pilot Study
- ClinicalTrials.gov ID
- NCT03865797
- Acronym / sponsor ID
- AZul
- Conditions
- Rugby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 15 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. Lower limb injuries are characteristic of rugby players. Core exercises aim to improve ankle stability. The ankle bandage in 8 is used in the approach to injuries to provide better stability in the joint.
Objectives. To assess the effectiveness of an intervention through motor control and bandage on lower limb stability in rugby players from 18 to 40 years old.
Study design. Randomized, single-blind clinical study with a follow-up period. Methodology. Twenty-five rugby players will be recruited to be randomized to the two study groups: experimental (specific exercises for the Core area and ankle bandage) and control (Core motor control). The intervention will last 4 weeks, with 2 weekly sessions of 15min each. The study variables will be: core motor control (measured with plate test, trunk flexion test and modified Biering-Sorensen test) and the stability of the lower limbs (measured with Double Heel Rise and Single Heel Rise test). A descriptive analysis will be carried out calculating the main statistical characteristics. Through an analysis of Shapiro-Wills the normality of the study groups will be calculated, and through an analysis with the parametric tests of t-student and ANOVA of repeated measures, we will evaluate the difference after the evaluations in both groups and the intra-e intersubject, respectively.
Expected results. Increased motor control of the core and stability of lower limbs.
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: ExperimentalBefore carrying out each session of the intervention, each subject included in the experimental group will have a sports bandage on both ankles. The intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up. The duration of each session will be 15 minutes, with two sessions per week, during a period of 4 weeks. |
| Control | Active comparator | Other: Control activeThe intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up. The duration of each session will be 15 minutes, with two sessions per week, during a period of 4 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Rugby players
- Both gender
- From 18 to 40 years old
- Federated.
Key exclusion criteria (4 listed)
- At the time of the study, they present an injury that prevents them from carrying out the proposed intervention
- Included in a personal training regime
- With musculoskeletal injuries in the ankle in the last 3 months
- Not sign 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 |
|---|---|---|
| ExperimentalAlso: Ankle stabilityEach session will last approximately 15 minutes, taking place during 2 days a week, in a period of 4 weeks. The intervention will be done before the training session. The intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up.The intervention will be done before the training session. | Other | Experimental |
| Control activeAlso: Ankle stabilityEach session will last approximately 15 minutes, taking place during 2 days a week, in a period of 4 weeks. The intervention will be done before the training session. The intervention by motor control will consist of the application of a series of Core exercises. The objective of the application of these exercises is to increase the control of the Core, and therefore improve the stability both central and of members. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises (13) will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up. | Other | Control |
Primary outcome
Change from baseline central stability after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The assessment of the central stability will be carried out with the modified Biering-Sorensen test. The subject must remain prone on a stretcher, while the part of the trunk should protrude through the front of the stretcher and completely parallel to the floor. The arms will remain crossed on the chest touching the shoulders at all times. The test ends when the subject supports any part of his body on the floor. The normative values of this test are 146 seconds for men and 189 for women, with the second being the unit of measurement for this test.
4 secondary outcomes
Change from baseline Core rating 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 trunk strength 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 ankle stability 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 ankle stability 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rugby, 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 4 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 central stability 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.