- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Carlos Sales Castellanos, Podología y Fisioterapia
- Número de teléfono: +34664833475
- Correo electrónico: carlos.sales@ucv.es
Copia de seguridad de contactos de estudio
- Nombre: Benjamín Cuenca Valero, Doctor en Podología
- Número de teléfono: +34636695885
- Correo electrónico: benjamin.cuenca@ucv.es
Ubicaciones de estudio
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Valencia
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Valencia, Valencia, España, 46001
- Reclutamiento
- Facultad de Medicina y Ciencias de la Salud - Universidad Católica de Valencia
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Contacto:
- Benjamín Cuenca Valero
- Número de teléfono: +34636695885
- Correo electrónico: benjamin.cuenca@ucv.es
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Sub-Investigador:
- Benjamín Cuenca Valero
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Contacto:
- Carlos Sales Castellanos
- Número de teléfono: +34664833475
- Correo electrónico: carlos.sales@ucv.es
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Investigador principal:
- Carllos Sales Castellanos, Podología y Fisioterapia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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).
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Hypermobile group (H+)
Children playing basketball with ligamentous hyperlaxity
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Non-hypermobile group (H-)
Children who play basketball and do not suffer from ligamentous hyperlaxity
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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"Ankle Test" with Leg Motion® (Check Your Motion®, Albacete, Spain)
Periodo de tiempo: Baseline
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Validated to numerically quantify ankle dorsiflexion, it provides very low levels of interobserver bias (ICC values ranged from 0.96 to 0.98)
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Baseline
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Easy Angle digital inclinometer
Periodo de tiempo: Baseline
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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.
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Baseline
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"Lower Body Test" at Octobalance (Check Your Motion®, Albacete, Spain)
Periodo de tiempo: Baseline
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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.
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Baseline
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Beighton Scale
Periodo de tiempo: Baseline
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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.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: 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
- Investigador principal: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UCV/2019-2020/063
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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