The Association Between Restricted Ankle Joint Dorsiflexion and Dynamic Knee Valgus (TOBROD)

November 2, 2023 updated by: CRISTINA ADILLÓN, University Rovira i Virgili

The Association Between Restricted Ankle Joint Dorsiflexion and Dynamic Knee Valgus in Non-injured Youth Federated Basketball Players: a Cross-sectional Study

The purpose of this study was to analyze if a low ankle dorsiflexion range is associate with dynamic knee valgus in youth basketball players.

Study Overview

Status

Status

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

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

Cross-sectional study. Ankle dorsiflexion range of motion was assessed by the Weight-bearing lunge test and the dynamic knee valgus by the Single leg squat test.

The participants were basketball players who belonged to youth basketball de-velopmental teams in the under-12 (U12), under-14 (U14), under-16 (U16) and under-17 (U17) categories. All participants were recruited by means of simple random sampling from the Catalan Basketball Federation during the 2018-2019 season. The participants were classified according to gender and age as stipulated by the rules determined an-nually for the respective official competitions. The study was carried out in the facilities of each club. The inclusion criteria were being age >12 and ≤17 at testing and actively competing during the study. Subjects were excluded if they had sustained any type of injury in the lower limbs before screening; presented any injury (overuse or acute) at the time of testing; if they had any oncological, psychological and/or psychiatric illnesses; or if they did not attend on the day of the assessment.

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.
Observational

Enrollment (Actual)

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.
791

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

  • Spain
      • Barcelona, Spain, 08018
        • Federación Catalana de Baloncesto

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

8 years to 13 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The participants were basketball players who belonged to youth basketball de-velopmental teams in the under-12 (U12), under-14 (U14), under-16 (U16) and under-17 (U17) categories.

Description

Inclusion Criteria:

  • Being age >12 and ≤17 at testing and actively competing during the study

Exclusion Criteria:

  • Subjects were excluded if they had sustained any type of injury in the lower limbs before screening; presented any injury (overuse or acute) at the time of testing; if they had any oncological, psychological and/or psychiatric illnesses; or if they did not attend on the day of the assessment.

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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 group
All participants allowed three practice trials for each test in this order: the Weight-bearing lunge test and the Single-leg squat test. Both of them were evaluated through the Leg Motion system (LegMotion, your MOtion®, Albacete, Spain)
Behavioral: Observation

Ankle joint dorsiflexion was evaluated with the Weight-bearing lunge test through the Leg Motion system (LegMotion, your MOtion®, Albacete, Spain). Subjects were instructed to try to bring the knee to touch the metal rod (initially placed at a distance of 10 cm) without lifting the heel off the ground. The distance achieved was recorded in centimeters.

Single-leg squat test was analyzed through the Leg Motion system (LegMotion, your MOtion®, Albacete, Spain). It consists of performing a monopodial squat to test dynamic knee valgus. They were to perform a single-leg squat to 30° knee flexion. The knee was considered to be aligned if the patella was over the second toe.

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
Ankle joint dorsiflexion
Time Frame: 1 year
he Weight-bearing Lunge Test measured with the Leg Motion® system (Check Your Motion, Albacete) was used. Ankle dorsiflexion was recorded in centimeters.
1 year
Dynamic lower extremity valgus
Time Frame: 1 year
The Single Leg Squat Test was used. The evaluator recorded a frontal and sagittal view with two filming devices. The knee was considered to be aligned if the patella was over the second toe.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 1 year
Years
1 year
Gender
Time Frame: 1 year
Male or female
1 year
Weight
Time Frame: 1 year
Kilograms
1 year
Height
Time Frame: 1 year
Centimeters
1 year
Wingspan
Time Frame: 1 year
Centimeters
1 year
Body mass index
Time Frame: 1 year
Kg/m2
1 year
Hypermobility
Time Frame: 1 year
Beighton's criteria (scores of >7 points out of a total of 9 points were considered hypermobile)
1 year
Age categories
Time Frame: 1 year
According to the age of the participant could compete in 4 categories: U12, U14, U16 or U17.
1 year

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 Rovira i Virgili

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)

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.
October 1, 2018

Primary Completion (Actual)

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.
May 20, 2019

Study Completion (Actual)

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.
June 30, 2019

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).
August 10, 2022

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.
August 10, 2022

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.
August 12, 2022

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.
November 7, 2023

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.
November 2, 2023

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.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 123/2018_3

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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