Ligamentous Hypermobility of the ToeNCT07589218
Assessment of Weight-bearing Ankle Range of Motion Using the Ankle Test and Lower Body Test and Its Relationship With Ligamentous Hyperlaxity in Child Basketball Players Aged 8 to 15 Years
An observational study of Ligamentous Hypermobility of the Toe and Children Basketball Players, run by Benjamín Cuenca Valero at 1 site in Spain.
Trial summary
This research aims to complement existing podiatric studies by providing information on the relationship between ligamentous hyperlaxity, a benign condition more frequently found in the pediatric population, and ankle range of motion in child basketball players aged 8-15. Read more about this study
- Who is it for?
- Ages 8 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ligamentous Hypermobility of the Toe, Children Basketball Players
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Study population: The study population will consist of male basketball players from the Puerto de Sagunto Basketball Club. The subjects who will participate in the study will be those who volunteer and meet the established selection criteria. The sample will include basketball players from the following age categories: U12 (8-10 years), U14 (10-12 years), and U16 (13-15 years).
Who may be able to join
- Subjects within the age range specified in the study.
- Signed and fully completed parental consent form.
- Participation in basketball as a sport twice a week, not including school physical education, or a total of 3 hours per week.
Who cannot join
- Subjects with injuries or any musculoskeletal impairment relevant to the measurement of the parameters to be evaluated.
- Any temporary illness that prevents the participant from being in full physical condition.
- Disorders related to loss of balance due to vestibular, cognitive, or cerebellar causes.
- Performance of a warm-up outside of the established protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
Valencia, Valencia, 46001
Benjamín Cuenca Valero, +34636695885, benjamin.cuenca@ucv.es
Carlos Sales Castellanos, +34664833475, carlos.sales@ucv.es
About this study
This research aims to complement existing podiatric studies by providing information on the relationship between ligamentous hyperlaxity, a benign condition more frequently found in the pediatric population, and ankle range of motion in child basketball players aged 8-15. Furthermore, this hyperlaxity will allow us to correlate it with the most frequent type of injury experienced by the participants and assess whether future research could develop a prevention plan for this population and extrapolate it to more professional categories.
Read the detailed description
Observational, cross-sectional, analytical (correlational and comparative) study: Measurements are taken at a single point in time. Groups defined by exposure (hypermobile vs. non-hypermobile) are compared. Associations between variables (hypermobility, ankle dorsiflexion, previous injuries) are analyzed.
The study consists of 3 clinical tests that will be performed only once on the same day. First, hypermobility will be assessed in 5 subjects using the validated Beighton scale. This simple scale is used by pediatricians to assess generalized hypermobility. It consists of 5 tests: passive maximum elbow extension, passive maximum knee extension, passive dorsiflexion of the metatarsophalangeal joint, forward trunk flexion with knees straight while trying to place palms on the floor, and passive thumb apposition on the forearm while the shoulder is flexed to 90 degrees and the elbow is kept extended with the hand pronated. A goniometer will be used in the tests. Secondly, the Ankle Test with leg movement will be performed, a specific test of ankle dorsiflexion under bipedal weight-bearing. The test consists of flexing the knee to touch the leg movement marker set at a distance of 10 cm, thus bringing the ankle forward (anterior tibial displacement). In this way, we will assess the maximum distance reached without lifting the heel, translating these measurements in centimeters as the ankle dorsiflexion range. Once this position is reached, we will use an inclinometer (Easy Angle), placing it 15 cm from the tibial tuberosity and obtaining the same parameter, but in degrees. Finally, the ankle range of motion under single-leg weight-bearing will be assessed with the Lower Body Test using the Octobalance. The test consists of moving the foot as far away as possible from an object positioned 30 cm in front, behind, and to the left side (lines along which we will assess the range of motion). In that maximum position, we will interpret, in centimeters and in degrees using inclinometry, the range of motion of the ankle under load.
- Keywords
- ankle, octobalance, stargazing test, dorsiflexion, hypermobility, range of movement, dynamic balance, movement quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypermobile group (H+) | Children playing basketball with ligamentous hyperlaxity | |
| Non-hypermobile group (H-) | Children who play basketball and do not suffer from ligamentous hyperlaxity |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Ankle Test" with Leg Motion® (Check Your Motion®, Albacete, Spain)
Validated to numerically quantify ankle dorsiflexion, it provides very low levels of interobserver bias (ICC values ranged from 0.96 to 0.98)
Measured: Baseline
Easy Angle digital inclinometer
It was used to obtain data on the inclination of the tibia relative to the ground, measured from the tibial tuberosity or 15 cm below it. It was also used to complete the Beighton scale in the ranges of finger, elbow, and knee hyperextension because it can function as a simple goniometer.
Measured: Baseline
"Lower Body Test" at Octobalance (Check Your Motion®, Albacete, Spain)
Considered innovative for the information it provides to prevent injuries, this patented system allows us to see limb imbalances, joint restrictions such as those in the ankle, and evaluate the quality of movement during dynamic balance.
Measured: Baseline
Beighton Scale
The most widely used tool for measuring generalized hypermobility in the healthcare field. Parameters used in this population have been measured using units from 0 to 9.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start9 Dec 2025
- Primary completion15 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligamentous Hypermobility of the ToeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamín Cuenca Valero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamín Cuenca Valero, Fundación Universidad Católica de Valencia San Vicente Mártir
- Investigators
- Benjamín Cuenca Valero, Doctor en Podología, Study director, C/ Quevedo, 2, 46001 Ciutat Vella, Valencia - Facultad de Medicina y Ciencias de la Salud - Universidad Católica de ValenciaCarlos Sales Castellanos, Podología y Fisioterapia, Principal investigator, C/ Quevedo, 2, 46001 Ciutat Vella, Valencia - Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589218
- Sponsor's protocol ID
- UCV/2019-2020/063
- Status last verified
- May 2026
- First submitted
- 14 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When they formally request it
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Weight-bearing Ankle Range of Motion Using the Ankle Test and Lower Body Test and Its Relationship With Ligamentous Hyperlaxity in Child Basketball Players Aged 8 to 15 Years
- ClinicalTrials.gov ID
- NCT07589218
- Acronym / sponsor ID
- UCV/2019-2020/063
- Keywords
- ankle, octobalance, stargazing test, dorsiflexion, hypermobility, range of movement, dynamic balance, movement quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Benjamín Cuenca ValeroUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 15 May 2026 (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.
This research aims to complement existing podiatric studies by providing information on the relationship between ligamentous hyperlaxity, a benign condition more frequently found in the pediatric population, and ankle range of motion in child basketball players aged 8-15. Furthermore, this hyperlaxity will allow us to correlate it with the most frequent type of injury experienced by the participants and assess whether future research could develop a prevention plan for this population and extrapolate it to more professional categories.
Detailed description
Observational, cross-sectional, analytical (correlational and comparative) study: Measurements are taken at a single point in time. Groups defined by exposure (hypermobile vs. non-hypermobile) are compared. Associations between variables (hypermobility, ankle dorsiflexion, previous injuries) are analyzed.
The study consists of 3 clinical tests that will be performed only once on the same day. First, hypermobility will be assessed in 5 subjects using the validated Beighton scale. This simple scale is used by pediatricians to assess generalized hypermobility. It consists of 5 tests: passive maximum elbow extension, passive maximum knee extension, passive dorsiflexion of the metatarsophalangeal joint, forward trunk flexion with knees straight while trying to place palms on the floor, and passive thumb apposition on the forearm while the shoulder is flexed to 90 degrees and the elbow is kept extended with the hand pronated. A goniometer will be used in the tests. Secondly, the Ankle Test with leg movement will be performed, a specific test of ankle dorsiflexion under bipedal weight-bearing. The test consists of flexing the knee to touch the leg movement marker set at a distance of 10 cm, thus bringing the ankle forward (anterior tibial displacement). In this way, we will assess the maximum distance reached without lifting the heel, translating these measurements in centimeters as the ankle dorsiflexion range. Once this position is reached, we will use an inclinometer (Easy Angle), placing it 15 cm from the tibial tuberosity and obtaining the same parameter, but in degrees. Finally, the ankle range of motion under single-leg weight-bearing will be assessed with the Lower Body Test using the Octobalance. The test consists of moving the foot as far away as possible from an object positioned 30 cm in front, behind, and to the left side (lines along which we will assess the range of motion). In that maximum position, we will interpret, in centimeters and in degrees using inclinometry, the range of motion of the ankle under load.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypermobile group (H+) | – | –Children playing basketball with ligamentous hyperlaxity |
| Non-hypermobile group (H-) | – | –Children who play basketball and do not suffer from ligamentous hyperlaxity |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of male basketball players from the Puerto de Sagunto Basketball Club. The subjects who will participate in the study will be those who volunteer and meet the established selection criteria. The sample will include basketball players from the following age categories: U12 (8-10 years), U14 (10-12 years), and U16 (13-15 years).
Key inclusion criteria (3 listed)
- Subjects within the age range specified in the study.
- Signed and fully completed parental consent form.
- Participation in basketball as a sport twice a week, not including school physical education, or a total of 3 hours per week.
Key exclusion criteria (4 listed)
- Subjects with injuries or any musculoskeletal impairment relevant to the measurement of the parameters to be evaluated.
- Any temporary illness that prevents the participant from being in full physical condition.
- Disorders related to loss of balance due to vestibular, cognitive, or cerebellar causes.
- Performance of a warm-up outside of the established protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
"Ankle Test" with Leg Motion® (Check Your Motion®, Albacete, Spain)
Time frame: Baseline
Validated to numerically quantify ankle dorsiflexion, it provides very low levels of interobserver bias (ICC values ranged from 0.96 to 0.98)
Easy Angle digital inclinometer
Time frame: Baseline
It was used to obtain data on the inclination of the tibia relative to the ground, measured from the tibial tuberosity or 15 cm below it. It was also used to complete the Beighton scale in the ranges of finger, elbow, and knee hyperextension because it can function as a simple goniometer.
"Lower Body Test" at Octobalance (Check Your Motion®, Albacete, Spain)
Time frame: Baseline
Considered innovative for the information it provides to prevent injuries, this patented system allows us to see limb imbalances, joint restrictions such as those in the ankle, and evaluate the quality of movement during dynamic balance.
Beighton Scale
Time frame: Baseline
The most widely used tool for measuring generalized hypermobility in the healthcare field. Parameters used in this population have been measured using units from 0 to 9.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. When they formally request it
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.
Benjamín Cuenca Valero, Doctor en Podología study director
C/ Quevedo, 2, 46001 Ciutat Vella, Valencia - Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
Carlos Sales Castellanos, Podología y Fisioterapia principal investigator
C/ Quevedo, 2, 46001 Ciutat Vella, Valencia - Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
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 Ligamentous Hypermobility of the Toe and Children Basketball Players, run by Benjamín Cuenca Valero 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Sales Castellanos, Podología y Fisioterapia (+34664833475, carlos.sales@ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Ankle Test" with Leg Motion® (Check Your Motion®, Albacete, Spain) (time frame: Baseline). The study lists 4 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 15 May 2026.