- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye)
- Medipol University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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동적 균형 평가
기간: 15 분
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스타 밸런스 테스트의 짧고 실용적인 변화 인 Y 밸런스 테스트는 동적 안정성을 평가하는 데 사용됩니다.
운동 선수는 Plisky et al.에 의해 정의 된 테스트 절차에 따라 Y 균형 테스트를 수행합니다.
길이가 125cm 인 3 개의 흰색 밴드는지면에 부착되어 y 모양을 형성하고, 90 °에서 작은 각도와 135 °에서 2 개의 큰 각도가 있고, 센티미터 규모의 표시는 손에 의해 밴드에 추가됩니다. 참가자는 코라 폴의 중심에 위치하여 극도의 페르타토 척도에서 테스트를 거치게됩니다. 시상면은 둘 다 중간 선과 정렬되었습니다.
참가자들은 몸에 인접한 장골 크레스트의 수준에서 손으로 서서, 발을 땅에서 측정하고, 각 방향으로, 전방, 후방 방향으로 다른 발로 닿아 각 방향으로 한 번 도달 할 수있는 마지막 지점을 가볍게 닿아야합니다.
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15 분
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자세 안정성 평가
기간: 20 분
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운동 선수의 자세 안정성과 압력 중심 (COP) 평가는 Prokin Force 플랫폼 (Prokin PK 252)을 사용하여 수행됩니다.
Prokin Pk 252는 정적 및 동적 균형 평가 및 훈련에 사용되는 독점 수용 시스템입니다.
이 연구에서 "정적 및 동적 안정성 평가 프로그램"은 안정계 플랫폼과 신체에 놓인 센서를 통해 참가자의 정적 서있는 자세에 대한 상세하고 정확한 데이터를 제공하는 데 사용될 것입니다 [47].
테스트 중에 참가자의 스탠딩 위치는 발로 어깨 너비를 분리하여 결정되며 발 위치는 플랫폼의 X 및 Y 축의 선을 참조로 사용하여 원점에서 동일한 거리에서 정렬됩니다.
이 테스트는 눈을 뜨고 눈을 감고있는 두 가지 하위 테스트로 관리됩니다.
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20 분
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Muscle and Ligament Size Assessment
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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발과 발목 능력 측정 (FAAM)
기간: 15 분
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선수의 신체 기능은 터키어의 발과 발목 능력 측정 (FAAM)을 사용하여 평가됩니다.
FAAM은 발과 발목과 관련된 근골격계 문제가있는 개인의 신체 기능을 평가하기 위해 개발 된 자체보고 측정 도구입니다.
FAAM은 일일 생활 (ADL) 하위 스케일의 21 개 항목 활동과 8 개 항목 스포츠 하위 스케일을 포함하여 총 29 개의 항목으로 구성됩니다.
Sports Subscale은 스포츠 관련 서브 클래스를 제공하여 스포츠 관련 활동을 수행하는 능력을 평가합니다.
각 질문은 0 (수행 할 수 없음)에서 4 (어려움없이 수행 할 수 있음) 범위의 5 포인트 리 커트 스케일을 사용하여 점수를 매 깁니다.
ADL 서브 스케일의 최대 점수는 84이고, 스포츠 하위 스케일의 최대 점수는 32입니다.
총 점수는 0% 내지 100% 범위의 백분율 점수로 계산되며, 점수는 더 높은 기능 수준을 나타냅니다 [48].
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15 분
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Cumberland Ankle Instability Tool (CAIT)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MedipolU
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