- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07579793
Differences in Ankle Sprain Risk Factors, Anterior Talofibular Ligament, Calcaneofibular Ligament and Lower Leg Muscles' Size Among Athletes With and Without Ankle Sprain Injury History: A Retrospective Study
This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals. The main goal of the research is to compare the risk factors associated with ankle sprains, characteristics of lower extremity muscle architecture, and structural features of the anterior talofibular ligament (ATFL) between athletes with and without a history of ankle sprains. Additionally, the study seeks to identify intrinsic factors that may lead to lateral ankle sprains and to investigate the link between these factors and structural changes related to chronic ankle instability. Overall, the study aims to contribute scientifically to the early detection of sprain risk in athletes and the development of personalised preventative intervention strategies.
The hypotheses of the study are as follows:
Hypothesis 1: In athletes with a history of ankle sprains, the strength of the muscles surrounding the ankle differs from that of their uninjured ankles and ankles of the athletes without a history of sprains.
Hypothesis 2: Athletes with a history of ankle sprains have a different level of proprioception (position sense) compared to athletes without a history of sprains.
Hypothesis 3: Athletes with a history of ankle sprains have different muscle and ligament sizes compared to their uninjured legs and the legs of athletes without a history of sprains.
Hypothesis 4: Dynamic balance differs between athletes with a history of ankle sprains and those without a history of ankle sprains.
Descripción general del estudio
Estado
Descripción detallada
Ankle instability exhibits a significant propensity to evolve into a chronic condition. Chronic ankle instability (CAI), defined by enduring residual symptoms following a sprain, recurrent sprains, and perceived instability, occurs in approximately 10% to 40% of cases. According to research conducted by Van Rijn and colleagues, between 5% and 33% of patients continued to experience pain one year subsequent to an ankle sprain, and one-third of the participants reported at least one re-sprain three years thereafter (4, 6).
Research indicates that a minimum of 73% of individuals who have sustained an ankle sprain exhibit persistent symptoms, including pain, a sensation of instability, proprioceptive disturbances, and impairments in neuromuscular control (7, 8). This condition presents a significant risk of both re-injury and the development of CAI. A history of multiple sprains and recurrent feelings of instability are identified as CAI, and the ongoing nature of this condition increases joint damage and the likelihood of osteoarthritis (9). The treatment and prevention of these injuries are costly and hinder athletes' return to training and competition (10).
Numerous intrinsic risk factors have been identified in the literature concerning the incidence and recurrence of lateral ankle sprains. These risk factors include a previous sprain history, gender, height, body weight, anatomical foot posture, alignment abnormalities (e.g., pes cavus, genu varum), joint laxity, joint range of motion, muscle strength, proprioception, reaction time, and postural control (11). Current studies show that, although there are differences in performance levels between genders, there is no significant difference in exposure to injury risk (12, 13). Conversely, it is stated that a direct relationship exists between height, body weight, ankle laxity, muscle strength, and postural control and lateral sprains (7). When assessed in terms of muscle strength, weakness in the ankle and hip muscles is an important risk factor for the development of LAS. Research shows that athletes with more than 15% strength asymmetry, especially during the pre-season, face a higher risk of sprain compared to those without such asymmetry. Postural balance disorders are also regarded as a significant intrinsic risk factor in the development of LAS. In conclusion, ankle sprains are common injuries among athletes and can lead to significant functional impairments. Identifying intrinsic risk factors for these injuries and implementing targeted preventive strategies through individual assessments are essential for both injury prevention and reducing the development of OAS. A review of current literature shows that there are limited studies that thoroughly examine changes in the architecture and functional performance of the muscles around the ankle in athletes who have experienced recurrent ankle sprains. This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Medipol University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- At least 5 years of active participation in any sport.
- Age between 18 and 35.
- A history of at least two clinically diagnosed LAS episodes with inflammatory symptoms like pain and swelling.
- The last sprain occurred at least 3 months before the study start, and the participant has fully returned to their sport.
- No previous surgeries affecting
Exclusion Criteria:
- Any history of ankle fracture.
- Surgery or systemic disease impacting sensorimotor function in the lower limb.
- Neurological disorders.
- Recent (within a month) acute injury to the lower extremity.
- Visual or vestibular issues that impair balance or coordination.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Control group
The control group will include athletes who have no history of ankle injuries.
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Ankle Instability Group
The group will consist of athletes diagnosed with chronic ankle instability (CAI).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluación de equilibrio dinámico
Periodo de tiempo: 15 minutos
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La prueba de equilibrio Y, una variación breve y práctica de la prueba de balance Star, se utilizará para evaluar la estabilidad dinámica.
Los atletas realizarán la prueba de equilibrio Y de acuerdo con los procedimientos de prueba definidos por Plisky et al.
Tres bandas blancas, cada una de 125 cm de longitud, se fijarán al suelo para formar una forma y, con el pequeño ángulo a 90 ° y los dos ángulos más grandes a 135 °, y las marcas a escala de centímetro se agregarán a las bandas a mano. Plano sagital, ambos alineados con la línea media.
Se les pedirá a los participantes que se paren con las manos al nivel de la cresta ilíaca, adyacente a sus cuerpos, y con el pie para medir en el suelo, para alcanzar con el otro pie en las direcciones anterior, posteromedial y posterolateral, una vez en cada dirección, y tocar ligeramente el punto final que pueden alcanzar.
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15 minutos
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Evaluación de estabilidad postural
Periodo de tiempo: 20 minutos
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La estabilidad postural de los atletas y las evaluaciones del centro de presión (COP) se realizarán utilizando la plataforma Prokin Force (Prokin PK 252).
El Prokin PK 252 es un sistema propioceptivo utilizado para la evaluación y el entrenamiento del equilibrio estático y dinámico.
En este estudio, el "programa de evaluación de estabilidad estática y dinámica" se utilizará para proporcionar datos detallados y precisos sobre la postura permanente estática de los participantes a través de la plataforma de estabilometría y los sensores colocados en el cuerpo [47].
Durante la prueba, la posición permanente de los participantes se determinará con el ancho de los hombros de los pies separados, y sus posiciones de pie se alinearán a distancias iguales desde el punto de origen, utilizando las líneas en los ejes x e y de la plataforma como referencias. Primero, se realizará una prueba de estabilidad estática de una sola pierna.
Esta prueba se administrará en dos sub-pruebas: con los ojos abiertos y con los ojos cerrados.
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20 minutos
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Muscle and Ligament Size Assessment
Periodo de tiempo: 1 hour
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Muscle and ATFL thickness will be measured using an HS60 ultrasound system (Samsung Medicine, Gangwon-do, Korea) with a 5-13 MHz linear probe.
Muscle cross-sectional area (MCA) of the ankle muscles will be assessed under two conditions: resting and maximal voluntary contraction (MVC), using B-mode ultrasound.
All measurements will be taken by a physical therapist experienced in musculoskeletal ultrasound.
Participants will lie on a medical bed with legs fully extended, the ankle in a neutral position, and muscles relaxed during imaging.
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1 hour
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Proprioception Assessment
Periodo de tiempo: 15 minute
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An ankle joint position sense test will be administered to assess deficiencies in ankle proprioception.
An electronic goniometer will be used to assess ankle joint position sense.
The reliability of this test among recreational athletes with ankle instability has been reported as ICC = 0.94-0.98
[45].
Athletes will be seated with their knees flexed at 90°, and their eyes will be closed to eliminate visual cues.
The ankle subtalar joint (STJN) will be held in a neutral position, and the goniometer will be set to zero.
The ankle will be passively moved through 10° dorsiflexion, 10° eversion, 15° plantar flexion, or 15° inversion, and then returned to the neutral position [46].
Participants will then be asked to actively perform these movements as closely as possible to the previous movements.
Three repeated measurements will be taken for each test angle, and deviations from the target angle will be recorded.
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15 minute
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Muscle Strength Assessment
Periodo de tiempo: 15 minute
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Isometric muscle strength measurements of the tibialis anterior, peroneus longus and brevis, gastrocnemius, and gluteus medius muscle groups will be performed using a MicroFET digital handheld dynamometer.
Measurements will be conducted with participants positioned supine, side-lying, and prone on an examination table [34].
For each muscle group, participants will be asked to perform three maximal voluntary contractions lasting 5 seconds each, with a 1-minute rest between contractions.
All measurements will be conducted by the same examiner, and all three recorded values will be used for data analysis.
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15 minute
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Medida de habilidad de pie y tobillo (FAAM)
Periodo de tiempo: 15 minutos
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Las funciones físicas de los atletas se evaluarán utilizando la versión turca de la medida de habilidad del pie y el tobillo (FAAM).
FAAM es una herramienta de medición de autoinforme desarrollada para evaluar las funciones físicas de las personas con problemas musculoesqueléticos relacionados con el pie y el tobillo.
La FAAM consiste en un total de 29 artículos, incluidas una subescala de 21 ítems de actividades de Daily Living (ADL) y una subescala deportiva de 8 ítems.
La subescala deportiva proporciona una subclase específica de deportes para evaluar la capacidad de realizar actividades relacionadas con el deporte.
Cada pregunta se califica utilizando una escala Likert de 5 puntos que varía de 0 (no se puede realizar) a 4 (capaz de funcionar sin dificultad).
El puntaje máximo para la subescala ADL es 84, mientras que el puntaje máximo para la subescala deportiva es 32.
Las puntuaciones totales se calculan como puntajes porcentuales que van del 0% al 100%, con una puntuación más alta que indica un nivel más alto de función [48].
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15 minutos
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Cumberland Ankle Instability Tool (CAIT)
Periodo de tiempo: 10 minute
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Cumberland Ankle Instability Tool Developed in 2006, the Cumberland Ankle Instability Tool 17 (CAIT) was the first to provide a numerical value measuring the level of ankle instability based on individuals' perceptions [41].
The CAIT scale, designed to assess functional ankle instability levels, consists of 9 questions; the maximum total score is 30 and the minimum is 0. A lower total score indicates more severe functional ankle instability.
Test-retest reliability was found to be excellent at 0.96.
The CAIT is the first tool to validly and reliably assess functional ankle instability.
In the study, the cutoff score was set at 27.5, with a sensitivity of 82.9% and a specificity of 74.7%.
Finally, the CAIT score has the potential to predict the risk of re-sprain in individuals with functional ankle instability.
Individuals with a sprained ankle and a low CAIT score have a higher likelihood of re-sprain, while those with a high CAIT score have a lower likelihood of re-sprain [42].
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10 minute
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- MedipolU
Información sobre medicamentos y dispositivos, documentos del estudio
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