Core Work and Sports Bandage in Rugby Players

January 23, 2020 updated by: Investigación en Hemofilia y Fisioterapia

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.

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Comunity Of Madrid
      • Madrid, Comunity Of Madrid, Spain, 28670
        • Universidad Europea de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rugby players
  • Both gender
  • From 18 to 40 years old
  • Federated.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Ankle stability
Active Comparator: Control
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.
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.
Other Names:
  • Ankle stability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
Screening visit, within the first seven days after treatment and after one month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2019

Primary Completion (Actual)

April 10, 2019

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AZul

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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