- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Carlos Sales Castellanos, Podología y Fisioterapia
- Numero di telefono: +34664833475
- Email: carlos.sales@ucv.es
Backup dei contatti dello studio
- Nome: Benjamín Cuenca Valero, Doctor en Podología
- Numero di telefono: +34636695885
- Email: benjamin.cuenca@ucv.es
Luoghi di studio
-
-
Valencia
-
Valencia, Valencia, Spagna, 46001
- Reclutamento
- Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
-
Contatto:
- Benjamín Cuenca Valero
- Numero di telefono: +34636695885
- Email: benjamin.cuenca@ucv.es
-
Sub-investigatore:
- Benjamín Cuenca Valero
-
Contatto:
- Carlos Sales Castellanos
- Numero di telefono: +34664833475
- Email: carlos.sales@ucv.es
-
Investigatore principale:
- Carllos Sales Castellanos, Podología y Fisioterapia
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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).
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Hypermobile group (H+)
Children playing basketball with ligamentous hyperlaxity
|
|
Non-hypermobile group (H-)
Children who play basketball and do not suffer from ligamentous hyperlaxity
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
"Ankle Test" with Leg Motion® (Check Your Motion®, Albacete, Spain)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: 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
- Investigatore principale: 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
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- UCV/2019-2020/063
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .