- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Medipol University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Dynamisk balancevurdering
Tidsramme: 15 minutter
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Y -balancetesten, en kort og praktisk variation af stjernbalancetesten, vil blive brugt til at vurdere dynamisk stabilitet.
Atleter udfører Y -balancetesten i henhold til de testprocedurer, der er defineret af Plisky et al.
Tre hvide bånd, hver 125 cm i længden, vil blive påført jorden for at danne en y-form, med den lille vinkel ved 90 ° og de to større vinkler ved 135 °, og centimeterskala-markeringer vil blive tilsat til båndene i hånden. Deltagerne vil være placeret i midten af apparaterne med den anden falanges af ekstremiteten, der blev testet i koronalen og de metatop Fuger i det sagittale plan, begge på linje med midtlinjen.
Deltagerne vil blive bedt om at stå med deres hænder på niveauet for iliac crest, støder op til deres kroppe, og med foden, der skal måles på jorden, for at nå ud med det andet fod i det forreste, posteromediale og posterolaterale retninger, en gang i hver retning og let berøre det sidste punkt, de kan nå.
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15 minutter
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Postural stabilitetsvurdering
Tidsramme: 20 minutter
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Atleternes posturale stabilitet og centrum for tryk (COP) vurderinger udføres ved hjælp af Prokin Force -platformen (Prokin PK 252).
Prokkin PK 252 er et propriosceptivt system, der bruges til statisk og dynamisk balancevurdering og træning.
I denne undersøgelse vil "statisk og dynamisk stabilitetsvurderingsprogram" blive brugt til at give detaljerede og nøjagtige data om deltagernes statiske stående holdning gennem stabilometri -platformen og sensorer, der er placeret på kroppen [47].
Under testen bestemmes deltagernes stående position med deres fødder skulderbredde fra hinanden, og deres fodpositioner vil blive justeret i lige store afstande fra oprindelsespunktet, ved hjælp af linjerne på platformens X- og Y-akser som referencer. Først vil der blive udført en enkelt ben statisk stabilitetstest.
Denne test administreres i to undertests: med øjne åbne og med lukkede øjne.
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20 minutter
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Muscle and Ligament Size Assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Fod- og ankelevne mål (FAAM)
Tidsramme: 15 minutter
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Atleternes fysiske funktioner vurderes ved hjælp af den tyrkiske version af fod- og ankelevneforanstaltningen (FAAM).
FAAM er et selvrapporteringsmålingsværktøj, der er udviklet til at vurdere de fysiske funktioner hos individer med muskuloskeletale problemer relateret til foden og ankelen.
FAAM består af i alt 29 genstande, inklusive en 21-punkts aktiviteter i Daily Living (ADL) underskala og en 8-punkts sportsunderskala.
Sportsunderskalaen giver en sportsspecifik underklasse for at vurdere evnen til at udføre sportsrelaterede aktiviteter.
Hvert spørgsmål scores ved hjælp af en 5-punkts Likert-skala, der spænder fra 0 (ikke er i stand til at udføre) til 4 (i stand til at udføre uden vanskeligheder).
Den maksimale score for ADL -underskalaen er 84, mens den maksimale score for sportsunderskalaen er 32.
De samlede scoringer beregnes som procentvis score fra 0% til 100%, med en højere score, der indikerer et højere niveau af funktion [48].
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15 minutter
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Cumberland Ankle Instability Tool (CAIT)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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