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Stretching the Posterior Capsule of the Shoulder in the Stability and the Throwing Performance in Handball Players

Primary Purpose

Shoulder Injuries and Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Injuries and Disorders focused on measuring Handball, Physiotherapy, Shoulder instability, Scapular dyskinesia, Female

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • Handball players federated in the Madrid Handball Federation
  • With an age range between 18 and 37 years
  • More than 2 years of handball sports
  • Currently participate in amateur competitions of First National Women's category.

Exclusion Criteria:

  • Have suffered a shoulder injury in the last six months
  • Who are currently doing some physiotherapy treatment
  • Who fail to participate in the established intervention and evaluation sessions
  • Refusing to sign the informed consent document.

Sites / Locations

  • Universidad Europea de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

The subjects that are part of the experimental group will carry out the intervention thought the performance of strengthening exercises of the shoulder and scapula, and capsular stretches.

Subjects that are part of the control group will perform shoulder strengthening exercises exclusively.

Outcomes

Primary Outcome Measures

Change from baseline functionality of the shoulder after treatment and at month
The functionality of the shoulder will be measured with the questionnaire Disability of the Arm, Shoulder and Hand (DASH). This scale consists of 30 items (of functionality). The score range of this scale ranges from 0 to 100 points (where a higher score indicates less functionality).

Secondary Outcome Measures

Change from baseline perception of effort after treatment and at month
The perception of effort will be measured with the modified Borg scale. In this instrument, 11 items are evaluated, with a score of 0 to 10 points, where 0 equals the minimum effort and 10 the maximum that they can perform.
Change from baseline launch speed after treatment and at month
The launch speed with the handball (56 cm and 375 grams of weight) will be measured using the Ball Throwing Speed Test. This measuring instrument requires the use of a stopwatch. The measurement will be made through the execution of 6 launches. The athletes must have both feet resting on the ground at a distance of 2.5 meters from the wall, making the throws at maximum speed, collecting the best result. The unit of measurement of this test is meters / second (where the higher the score, the faster the launch).
Change from baseline shoulder stability after treatment and at month
The assessment of shoulder stability will be carried out using the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST). The player will be placed in the ironing position with the arms extended and supported on the ground. The objective is to assess how many times it is able to raise the arm to touch the opposite shoulder in 15 seconds. This test is measured by the number of repetitions you perform (the greater the number of repetitions, the better the stability of the shoulder).
Change from baseline distance range after treatment and at month
Distance range will be calculated using the Upper Quarter Y-Balance Test (YBT-UQ Test). We will use 3 different angles from where the handball players, with a support arm, should push an object on a tape measure. This test measures the stability and mobility of the upper limbs of the body. The unit of measurement for this test is centimeters (the greater the distance traveled in cm, the better the reach distance of the upper limbs).
Change from baseline strength of upper limbs after treatment and at month
The strength of upper limbs will be evaluated with Overhead Medicine Ball Throw (OMBT). The athletes, with both feet resting on the ground and using a reference point "0" of the tape measure, will throw a medicine ball over the head in order to reach the greatest possible distance. This distance will be measured with a tape measure, the meter being the unit of measurement the centimeter (the greater the distance, the greater the strength of the upper limbs)
Change from baseline shoulder range of motion after treatment and at month
The measurement of the range of movement of the shoulder will be made with a universal goniometer. The movements of external and internal rotation will be measured. The women will be in the supine position with the scapula and the spine stabilized. The goniometer axis will be placed in the olecranon, while the fixed arm will be located vertical to the axis of the humerus, and the mobile arm parallel to the forearm by the ulna axis. The unit of measurement will be in degrees, with the normal range of mobility being 70 to 90 degrees in internal and external rotation, respectively.

Full Information

First Posted
March 4, 2019
Last Updated
January 23, 2020
Sponsor
Investigación en Hemofilia y Fisioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT03866070
Brief Title
Stretching the Posterior Capsule of the Shoulder in the Stability and the Throwing Performance in Handball Players
Official Title
Efficacy of a Physiotherapy Intervention by Stretching the Posterior Capsule of the Shoulder in the Stability of the Glenohumeral Joint and the Throwing Performance in Handball Players. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Investigación en Hemofilia y Fisioterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Handball is a sport with a high prevalence of shoulder injuries due to the overuse that causes a glenohumeral internal rotation deficit, and excess of external rotation and scapular dyskinesia. Stretching is essential to restore physiological movement and improve strength. Aim: To evaluate the efficacy of a posterior capsule stretching and strengthening of the shoulder and scapular program in handball players from 18 to 37 years old. Study design: randomized clinical trial, multicenter, single-blind with follow-up period. Methods: 60 handball players will be randomly assigned to the two study groups (experimental and control). The intervention will last 4 weeks, with 3 weekly sessions with a duration of 21 and 12 minutes each. The study variables will be: range of motion in internal and external rotation (goniometer), throwing speed (Ball Throwing Speed Test), functionality (DASH questionnaire), perceived exertion (Borg scale), glenohumeral stability (CKCUEST y YBT-UQ Test) and the throwing force (Overhead Medicine Ball Throw). The intervention will consist in the application of stretching of the posterior shoulder capsule with an exercise protocol. A Kolmogorov-Smirnov analysis will calculate the normality of the distribution. In case of homogeneity of the groups, with the t-student test of repeated measurements and an ANOVA of repeated averages, the difference between the different evaluations and the intra- and inter-subject effect will be calculated. Expected results: Improved range of motion of the shoulder, strength and throwing speed after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries and Disorders
Keywords
Handball, Physiotherapy, Shoulder instability, Scapular dyskinesia, Female

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
The subjects that are part of the experimental group will carry out the intervention thought the performance of strengthening exercises of the shoulder and scapula, and capsular stretches.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects that are part of the control group will perform shoulder strengthening exercises exclusively.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
Strengthening exercises and capsular stretches
Intervention Description
Two exercises will be done to strengthen the external rotation (using elastic bands): standing with 90 degrees of shoulder abduction and elbow flexion and also in standing with the shoulder in neutral position and the elbow flexed to 90 degrees. Subjects will perform 3 sets of 10 repetitions with the band slightly stretched, at a distance of 0.70 m from the wall. Dumbbell exercises will be performed through 4 exercises: flexion in the horizontal plane of 135º, external rotation in lateral decubitus, horizontal abduction with external rotation, and extension in prone position. There will be 5 repetitions each exercise of 3 seconds each, with 2 minutes of rest between exercises.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Strengthening exercises
Intervention Description
Two exercises will be done to strengthen the external rotation, using elastic bands. The first, standing, with 90 degrees of shoulder abduction and elbow flexion. The second, also in standing, with the shoulder in neutral position and the elbow flexed to 90 degrees. Subjects will perform 3 sets of 10 repetitions with the band slightly stretched, at a distance of 0.70 m from the wall. The band will be subject to a surface, at an equal distance from the subject's elbow to the ground. The repetitions will last one second in concentric external rotation and two seconds in eccentric external rotation, with a rest of 30 seconds between series.
Primary Outcome Measure Information:
Title
Change from baseline functionality of the shoulder after treatment and at month
Description
The functionality of the shoulder will be measured with the questionnaire Disability of the Arm, Shoulder and Hand (DASH). This scale consists of 30 items (of functionality). The score range of this scale ranges from 0 to 100 points (where a higher score indicates less functionality).
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Outcome Measure Information:
Title
Change from baseline perception of effort after treatment and at month
Description
The perception of effort will be measured with the modified Borg scale. In this instrument, 11 items are evaluated, with a score of 0 to 10 points, where 0 equals the minimum effort and 10 the maximum that they can perform.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline launch speed after treatment and at month
Description
The launch speed with the handball (56 cm and 375 grams of weight) will be measured using the Ball Throwing Speed Test. This measuring instrument requires the use of a stopwatch. The measurement will be made through the execution of 6 launches. The athletes must have both feet resting on the ground at a distance of 2.5 meters from the wall, making the throws at maximum speed, collecting the best result. The unit of measurement of this test is meters / second (where the higher the score, the faster the launch).
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline shoulder stability after treatment and at month
Description
The assessment of shoulder stability will be carried out using the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST). The player will be placed in the ironing position with the arms extended and supported on the ground. The objective is to assess how many times it is able to raise the arm to touch the opposite shoulder in 15 seconds. This test is measured by the number of repetitions you perform (the greater the number of repetitions, the better the stability of the shoulder).
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline distance range after treatment and at month
Description
Distance range will be calculated using the Upper Quarter Y-Balance Test (YBT-UQ Test). We will use 3 different angles from where the handball players, with a support arm, should push an object on a tape measure. This test measures the stability and mobility of the upper limbs of the body. The unit of measurement for this test is centimeters (the greater the distance traveled in cm, the better the reach distance of the upper limbs).
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline strength of upper limbs after treatment and at month
Description
The strength of upper limbs will be evaluated with Overhead Medicine Ball Throw (OMBT). The athletes, with both feet resting on the ground and using a reference point "0" of the tape measure, will throw a medicine ball over the head in order to reach the greatest possible distance. This distance will be measured with a tape measure, the meter being the unit of measurement the centimeter (the greater the distance, the greater the strength of the upper limbs)
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline shoulder range of motion after treatment and at month
Description
The measurement of the range of movement of the shoulder will be made with a universal goniometer. The movements of external and internal rotation will be measured. The women will be in the supine position with the scapula and the spine stabilized. The goniometer axis will be placed in the olecranon, while the fixed arm will be located vertical to the axis of the humerus, and the mobile arm parallel to the forearm by the ulna axis. The unit of measurement will be in degrees, with the normal range of mobility being 70 to 90 degrees in internal and external rotation, respectively.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Handball players federated in the Madrid Handball Federation With an age range between 18 and 37 years More than 2 years of handball sports Currently participate in amateur competitions of First National Women's category. Exclusion Criteria: Have suffered a shoulder injury in the last six months Who are currently doing some physiotherapy treatment Who fail to participate in the established intervention and evaluation sessions Refusing to sign the informed consent document.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Cuesta-Barriuso, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Europea de Madrid
City
Madrid
State/Province
Comunity Of Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

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Stretching the Posterior Capsule of the Shoulder in the Stability and the Throwing Performance in Handball Players

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