Overhead Athletes Clinical Trial
Official title:
Effectiveness of a Training Program Through Plyometric, Proprioceptive and Strength Exercises in Order to Observe an Improvement of the Strength, Stability and Functional Stability of the Shoulder in Rugby Players
| NCT number | NCT04254055 |
| Other study ID # | FEF |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 8, 2020 |
| Est. completion date | May 10, 2020 |
| Verified date | September 2021 |
| Source | Investigación en Hemofilia y Fisioterapia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Introduction. Shoulder injury is the pathology that causes the longest downtime in rugby players, representing 66% of upper limb injuries in this discipline. The lack of strength, and instability are factors that predispose the athlete to suffer this type of dysfunction. The intervention of the study consists of a training program that counteract these dysfunctions. Aim. Assess the effectiveness of a program using plyometric, proprioceptive and strength exercises on 18-45-year-old rugby players to improve strength and stability. Study design. Clinical randomized, prospective, single-blind and trackable. Methods. The subjects included in two study groups, experimental and control, will be attributed a random order. The treatment will last 4 weeks, with 2 weekly sessions, of approximately 25 minutes each. The study variables will be strength, stability and functionality. A descriptive statistical analysis will be carried out calculating the main statistical characteristics. Through of a Kolmogorov analysis the normality of the sample will be assessed. A t-Student test for paired samples will be performed for the difference between the means of the dependent and independent variables. An analysis if variance (ANOVA) for repeated measures will be used to compare the means and checked to what extent the intra-subjects factors influence the dependent variables. Expected results. Improved shoulder strength, stability and functionality for the subjects on which the study is carried out.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | May 10, 2020 |
| Est. primary completion date | April 30, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - Federated rugby players - Male - 18 to 45 years old - Currently participating in regional competitions Exclusion Criteria: - Being treated with anti-inflammatory drugs - Having suffered an upper limb injury in the month prior to the intervention - Have undergone surgery for any shoulder pathology during the previous 12 months - Who have suffered or suffer from a serious and / or metabolic disease - That they have not signed the informed consent |
| Country | Name | City | State |
|---|---|---|---|
| Spain | European University of Madrid | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Investigación en Hemofilia y Fisioterapia |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline strength after treatment and at 1 month | The strength assessment will be carried out with a dynamometer. The subject will stand up and the examiner will indicate when the movement should begin. The dynamometer will be positioned to measure the strength of the shoulder abductors and rotators in the position of 90º of abduction and 90º of external rotation. The unit of measure is the Newton | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
| Secondary | Change from baseline stability after treatment and at 1 month | It will be assessed with the Closed Kinetic Chain Upper Extremity Stability Test. The initial position of the test is a push-up position with the upper extremities perpendicular to the ground. We will use two strips of 3.80 cm tape stuck on the floor and separated 91.44cm apart. The subjects will carry one of the hands until they touch the other strip of tape and return to the initial position. The touches will be counted every time one of the tape strips is touched in a total time of 15 seconds. Each subject will perform a warm-up, followed by 3 attempts with a break between attempts, of 45 seconds, averaging the 3 data obtained. | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
| Secondary | Change from baseline functionality after treatment and at 1 month | The assessment will be carried out with the Simple Shoulder Test. This test is a questionnaire of 12 questions, with two answer options: yes (when the subject is able to perform the task) and no (when he is not able to do it). The results obtained have a scoring range from 0 to 12, with 0 being the lowest functionality and 12 being the highest. | Screening visit, within the first seven days after treatment and after one month follow-up visit |