Exercise Program for Lower Limb Pronation

May 1, 2018 updated by: Gabriel Domínguez-Maldonado, University of Seville

Clinical Trail of Therapeutic Physical Exercise for Lower Limb Overpronation in Rugby Young Players

Introduction: The prevalence of biomechanical alterations in the the lower limbs in school-age children is increasing. The aim of this study is to assess the effectiveness of a therapeutic exercise program in child athletes with lower limb overpronation during gait.

Methods: Relevant databases (PubMed and SCOPUS) were searched. A total of 123 young athletes (aged 9-12 years) will be evaluated. Subjects will be tested biomechanical analysis including all relevant angles, as follows: the Helbing angle, the femorotibial angle, and the Fick angle in both limbs. Subjects will be divided into two groups at random. Children in experimental group will participate in an exercise program for three months. Children in control group will not received treatment for three months. After the study, these children will receive the same treatment as children in experimental group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Firstly, a biomechanical analysis of gait will be performed at CAMD, using a modular electronic baropodometer (Diagnostic Support Walk®), Milletrix Applicazione MFC® (Diasu, Italia) and a video camera (Diagnostic Support S.R.L., Diasu, Italy). We will measure the parameters characterizing lower limb overpronation. The parameters measured during walking will be: Fick angle, femorotibial angle and Helbing angle. Skin Surface markers on anatomical references were placed to measure femorotibial and Helbing angle. To measure the Fick angle we will take a footprint.

Children in the experimental group will be treated with functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle.

The selection of the prescribed exercises will be performed according to the principal activity of different muscles and functional impact on the gait. Previous experiences in implementing this exercises program has shown us positive results after three months of application. That is why this temporary intervention for the period was determined.

Parents of children will be instructed to monitor the exercises. They will be given a timetable for controlling autonomous treatment sessions, as well as the dates of the revisions with the evaluator. These reviews will be conducted every 15 days, analyzing the evolution of musculoskeletal disorders, and, if necessary, modifications will be applied in the exercise program.

After three months, a new evaluation will be performed in the same manner as the initial assessment. The purpose of this evaluation is to determine the existence or not of changes in biomechanical parameters studied due the exercices program application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Gabriel Domínguez-Maldonado, PhD
  • Phone Number: 0034665329628
  • Email: gdominguez@us.es

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Recruiting
        • Gabriel Domínguez-Maldonado
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • being 9-12 years of age
  • having being federated for at least two years (to be a member of the Andalusian Rugby Federation)
  • training at least two hours three days a week;
  • having lower limb overpronation (Fick angle <12º, femorotibial angle <170º and Helbing angle <175º)

Exclusion Criteria:

  • lower limb asymmetry
  • biomechanical alteration secondary to an acute disorder

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental
exercise program
Other: exercise program
functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle,
NO_INTERVENTION: Control
observation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
lower limb pronation reduction
Time Frame: 3 months
anthropometric parameters (Fick angle)
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Seville

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 (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pornation lower limb

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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