- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Medipol University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Avaliação de equilíbrio dinâmico
Prazo: 15 minutos
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O teste de equilíbrio Y, uma variação curta e prática do teste de balanço das estrelas, será usada para avaliar a estabilidade dinâmica.
Os atletas realizarão o teste de equilíbrio Y de acordo com os procedimentos de teste definidos por Plisky et al.
Three white bands, each 125 cm in length, will be affixed to the ground to form a Y shape, with the small angle at 90° and the two larger angles at 135°, and centimeter-scale markings will be added to the bands by hand.Participants will be positioned at the center of the apparatus with the second phalanges of the extremity being tested in the coronal plane and the metatarsophalangeal joints in O plano sagital, ambos alinhados com a linha média.
Os participantes serão solicitados a ficar com as mãos no nível da crista ilíaca, adjacente ao corpo, e com o pé a ser medido no chão, para alcançar o outro pé no ponto anterior, posteromedial e posterolateral, uma vez em cada direção e tocar levemente o ponto final que podem alcançar.
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15 minutos
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Avaliação de estabilidade postural
Prazo: 20 minutos
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A estabilidade postural dos atletas e as avaliações do centro de pressão (COP) serão realizadas usando a plataforma Prokin Force (Prokin PK 252).
O Prokin PK 252 é um sistema proprioceptivo usado para avaliação e treinamento de equilíbrio estático e dinâmico.
Neste estudo, o "Programa de Avaliação de Estabilidade estática e dinâmica" será usado para fornecer dados detalhados e precisos sobre a postura estática dos participantes através da plataforma de estabilometria e sensores colocados no corpo [47].
Durante o teste, a posição em pé dos participantes será determinada com a largura dos pés da largura dos ombros e as posições dos pés serão alinhadas a distâncias iguais do ponto de origem, usando as linhas nos eixos x e y da plataforma como referências. Primeira, um teste de estabilidade estática de uma perna será realizada.
Este teste será administrado em dois sub-testes: com os olhos abertos e com os olhos fechados.
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20 minutos
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Muscle and Ligament Size Assessment
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Medida de habilidade do pé e tornozelo (faam)
Prazo: 15 minutos
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As funções físicas dos atletas serão avaliadas usando a versão turca da medida de habilidade do pé e do tornozelo (FAAM).
O FAAM é uma ferramenta de medição de autorrelato desenvolvida para avaliar as funções físicas de indivíduos com problemas músculo-esqueléticos relacionados ao pé e ao tornozelo.
A FAAM consiste em um total de 29 itens, incluindo uma subescala de 21 itens de vida diária (ADL) e uma subescala esportiva de 8 itens.
A subescala esportiva fornece uma subclasse específica de esportes para avaliar a capacidade de realizar atividades relacionadas ao esporte.
Cada pergunta é pontuada usando uma escala Likert de 5 pontos, variando de 0 (incapaz de executar) a 4 (capaz de executar sem dificuldade).
A pontuação máxima para a subescala ADL é de 84, enquanto a pontuação máxima para a subescala esportiva é de 32.
As pontuações totais são calculadas como pontuações percentuais que variam de 0% a 100%, com uma pontuação mais alta indicando um nível mais alto de função [48].
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15 minutos
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Cumberland Ankle Instability Tool (CAIT)
Prazo: 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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