- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07589218
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
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carlos Sales Castellanos, Podología y Fisioterapia
- Phone Number: +34664833475
- Email: carlos.sales@ucv.es
Study Contact Backup
- Name: Benjamín Cuenca Valero, Doctor en Podología
- Phone Number: +34636695885
- Email: benjamin.cuenca@ucv.es
Study Locations
-
-
Valencia
-
Valencia, Valencia, Spain, 46001
- Recruiting
- Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
-
Contact:
- Benjamín Cuenca Valero
- Phone Number: +34636695885
- Email: benjamin.cuenca@ucv.es
-
Sub-Investigator:
- Benjamín Cuenca Valero
-
Contact:
- Carlos Sales Castellanos
- Phone Number: +34664833475
- Email: carlos.sales@ucv.es
-
Principal Investigator:
- Carllos Sales Castellanos, Podología y Fisioterapia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
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).
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"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)
|
Baseline
|
|
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.
|
Baseline
|
|
"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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Benjamín Cuenca Valero, Doctor en Podología, C/ Quevedo, 2, 46001 Ciutat Vella, Valencia - Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
- Principal Investigator: Carlos Sales Castellanos, Podología y Fisioterapia, C/ Quevedo, 2, 46001 Ciutat Vella, Valencia - Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UCV/2019-2020/063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Ligamentous Hypermobility of the Toe
-
Integra LifeSciences ServicesCompletedClaw Toe | Hammer Toe | Shortening 2nd Toe | Revision of Arthrodesis or Arthroplasty FailureFrance, Belgium, Switzerland
-
University of SevilleCompletedSurgery | Hammer Toe | Deformity of Toe | Phalanx; Dislocation Toe(S)Spain
-
Susan HassenbeinWithdrawnAcquired Deformities of ToeUnited States
-
Centre Hospitalier Universitaire DijonCompletedPatients With Type 1 or 2 Diabetes | Lesion Situated on a Toe or on the Plantar or Dorsal Side of the FootFrance
-
Bezmialem Vakif UniversityCompletedFunctional Capacity | Joint Hypermobility | Postural Control | Femoral Anteversion | Rotational Malalignment of the Lower Extremity | Lower Extremity Muscle Strength | Lower Extremity Functional ScaleTurkey
-
Endeavor HealthCompletedHypermobility of Interphalangeal Joints | Swan-Neck DeformityUnited States
-
Stryker Trauma GmbHCompletedOsteoarthritis | Rheumatoid Arthritis | Bunion | Hallux Limitus of Left Great Toe | Arthritis of 1st Metatarsophalangeal Joint | Hallux Limitus of Right Great ToeItaly
-
Universidad Complutense de MadridCompletedFoot Diseases | Orthopedic Disorder | Toe Joint Deformity | Treatment | Metatarsalgia | Foot | Subluxation of Toe JointSpain
-
VA Office of Research and DevelopmentCompletedAmputation Wound | Traumatic Amputation of Toe | Dysvascular Amputation of Lower LimbUnited States
-
Fatih Sultan Mehmet Training and Research HospitalCompleted