NCT03865797

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 4, 2019

Last Update Submit

January 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

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.

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.

Other: Control active

Interventions

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.

Also known as: Ankle stability
Experimental

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.

Also known as: Ankle stability
Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 7, 2019

Study Start

March 8, 2019

Primary Completion

April 10, 2019

Study Completion

June 15, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations