Knee InjuriesTOBRODNCT05500131
The Association Between Restricted Ankle Joint Dorsiflexion and Dynamic Knee Valgus
An observational study of Knee Injuries and Ankle Injuries and Disorders, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The purpose of this study was to analyze if a low ankle dorsiflexion range is associate with dynamic knee valgus in youth basketball players. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Knee Injuries, Ankle Injuries and Disorders, Movement, Abnormal
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 791 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Child
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.
Who may be able to join
- Being age >12 and ≤17 at testing and actively competing during the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Observation
- Keywords
- Basketball, Adolescent, Knee valgus, Range of motion, Ankle
- Medical subject headings
- Knee Injuries, Ankle Injuries, Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle joint dorsiflexion
he Weight-bearing Lunge Test measured with the Leg Motion® system (Check Your Motion, Albacete) was used. Ankle dorsiflexion was recorded in centimeters.
Measured: 1 year
Dynamic lower extremity valgus
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.
Measured: 1 year
Secondary outcomes (8)
Age
Years
Measured: 1 year
Age categories
According to the age of the participant could compete in 4 categories: U12, U14, U16 or U17.
Measured: 1 year
Gender
Male or female
Measured: 1 year
Weight
Kilograms
Measured: 1 year
Height
Centimeters
Measured: 1 year
Wingspan
Centimeters
Measured: 1 year
Body mass index
Kg/m2
Measured: 1 year
Hypermobility
Beighton's criteria (scores of >7 points out of a total of 9 points were considered hypermobile)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Oct 2018
- Primary completion20 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 791 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CRISTINA ADILLÓN, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500131
- Sponsor's protocol ID
- 123/2018_3
- Acronym
- TOBROD
- Status last verified
- Nov 2023
- First submitted
- 10 Aug 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Restricted Ankle Joint Dorsiflexion and Dynamic Knee Valgus in Non-injured Youth Federated Basketball Players: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05500131
- Acronym / sponsor ID
- TOBROD / 123/2018_3
- Keywords
- Basketball, Adolescent, Knee valgus, Range of motion, Ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 791 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to analyze if a low ankle dorsiflexion range is associate with dynamic knee valgus in youth basketball players.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Behavioral: ObservationAll 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) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Being age >12 and ≤17 at testing and actively competing during the study
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationAnkle 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. | Behavioural | Experimental group |
Primary outcome
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.
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.
8 secondary outcomes
Age
Time frame: 1 year
Age categories
Time frame: 1 year
Gender
Time frame: 1 year
Weight
Time frame: 1 year
Height
Time frame: 1 year
Wingspan
Time frame: 1 year
Body mass index
Time frame: 1 year
Hypermobility
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Ankle Injuries and Disorders, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle joint dorsiflexion (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.