- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07760233
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training on Visuo-Motor Reaction Performance, Fear Avoidance Behaviors Related to Sports Injuries and Kinesiophobia in Amateur Athletes With Chronic Ankle Instability
Chronic ankle instability (CAI) is a common condition after lateral ankle sprain. CAI is characterized by mechanical and/or functional instability, or recurrent episodes of "giving way," persisting for at least 12 months after the initial injury, and is associated with limitations in activity and and participation. Contemporary theoretical models emphasize that CAI should not be explained solely by biomechanical or neuromuscular deficits, but rather as a dynamic condition shaped by the interaction of motor-behavioral, sensory-perceptual, psychological, and environmental factors.
Postural stabilization training is commonly used to improve balance and neuromuscular control in individuals with CAI. However, individuals with CAI may show increased reliance on visual information and altered visual-vestibular sensory reweighting during postural control tasks. The vestibulo-ocular reflex (VOR) contributes to gaze stability and visual clarity during head movements and may also be related to neurocognitive processes such as attention and processing speed. This study is designed as a randomized controlled, prospective, parallel-group, pretest-posttest design trial to investigate whether VOR exercises added to postural stabilization training improve visuo-motor reaction performance, fear avoidance behavior related to sports injuries and kinesiophobia in amateur athletes with CAI.
Přehled studie
Postavení
Detailní popis
Chronic ankle instability (CAI) is a common condition following lateral ankle sprain and is characterized by mechanical and/or functional instability, recurrent episodes of "giving way," and activity limitations persisting for at least 12 months after the initial injury. Contemporary models suggest that CAI should not be explained only by biomechanical or neuromuscular deficits, but rather as a multidimensional condition influenced by motor-behavioral, sensory-perceptual, psychological, and environmental factors. In amateur athletes, CAI may be overlooked or undertreated despite the high sensorimotor and cognitive demands of sport-specific activities. During dynamic sport-related tasks, athletes must rapidly perceive visual information, select an appropriate motor response, and execute this response while maintaining postural control. Therefore, visuo-motor reaction performance assessed during dynamic balance may provide a meaningful functional outcome for evaluating sport-specific sensorimotor control in individuals with CAI.
Postural stabilization training is commonly used in CAI rehabilitation to improve balance, proprioceptive function, and neuromuscular control. However, individuals with CAI may demonstrate increased reliance on visual information and altered visual-vestibular sensory reweighting during postural control tasks. The vestibulo-ocular reflex (VOR) contributes to gaze stability and visual clarity during head movements. Therefore, integrating VOR exercises into postural stabilization training may support visual stabilization, sensory integration, and motor response performance during dynamic balance tasks.
Psychological factors may also influence functional performance and return-to-sport behavior after musculoskeletal injury. Fear-avoidance behavior related to sports injuries and kinesiophobia may lead individuals to avoid movement or sport-specific activities due to fear of reinjury. These factors may be associated not only with traditional motor performance outcomes, but also with visual attention strategies, attentional resource allocation, and reactive motor response processes.
This study is designed as a randomized controlled, prospective, parallel-group, pretest-posttest design trial to investigate whether VOR exercises added to postural stabilization training improve visuo-motor reaction performance, fear avoidance behavior related to sports injuries and kinesiophobia in amateur athletes with CAI. Visuo-motor reaction performance will be assessed using a Reactive Balance Test, Fear-avoidance behavior related to sports injuries will be evaluated through Athlete Fear Avoidance Questionnaire - Turkish Version and kinesiophobia will be assessed using Tampa Scale for Kinesiophobia - Turkish Version. Approximately 56 participants with CAI will participate in an exercise program for six weeks, three days a week. Each session will last approximately 45 minutes, including 40 minutes of exercise and 5 minutes of ankle mobilization. Participants will be randomized into either a Postural Stabilization Training Group or a Postural Stabilization Training plus Vestibulo-Ocular Reflex (VOR) Exercises Group. Outcomes will be assessed at baseline, at the end of the six week intervention and at 4-week follow-up.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Mustafa Fatih Çetintaş, PT, PhD (c)
- Telefonní číslo: +905336654580
- E-mail: mfcetintas@gmail.com
Studijní záloha kontaktů
- Jméno: Pelin Pişirici, PT, PhD
- Telefonní číslo: +905055016076
- E-mail: pelin.pisirici@bau.edu.tr
Studijní místa
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Turkey
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Istanbul, Turkey, Turecko (Türkiye), 34728
- Nábor
- Reset Fizyoterapi
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Kontakt:
- Mustafa F Çetintaş, PhD Candidate
- Telefonní číslo: +905336654580
- E-mail: mfcetintas@gmail.com
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Kontakt:
- İrem Ulkat, PT
- Telefonní číslo: +905386957456
- E-mail: iremulkat6@gmail.com
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Vrchní vyšetřovatel:
- Mustafa Fatih Çetintaş, PT, PhD (c)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Being between 18 and 35 years of age.
- Being classified as a Tier 2 athlete according to the McKay et al. Participant Classification Framework (trained/developmental level).
- Having a history of at least one lateral ankle sprain (LAS) occurring at least 12 months before enrollment, resulting in swelling, pain, and functional impairment, and followed by persistent instability.
- Having the most recent ankle sprain at least 3 months before study enrollment.
- Having a history of recurrent ankle sprains or episodes of "giving way."
- Having a diagnosis of unilateral chronic ankle instability (CAI).
- Having a Cumberland Ankle Instability Tool - Turkish Version (CAIT-T) score of ≤24.
- Having a Foot and Ankle Ability Measure (FAAM) score of <90%.
- Having a Foot and Ankle Ability Measure Sports subscale (FAAM-S) score of <80%.
- A side-to-side difference of ≥2.5 cm in Weight-Bearing Lunge Test distance, with the affected side demonstrating less dorsiflexion than the unaffected side.
Exclusion Criteria:
- History of acute lateral ankle sprain within the last 3 months.
- History of lower extremity surgery.
- History of acute injury to other musculoskeletal structures of the lower extremity joints within the last 3 months that affected joint integrity and function and caused interruption of desired physical activity for at least one day.
- History of balance or vestibular disorders, including cerebellar, vestibular, cochlear, or inner ear dysfunction.
- Visual problems that may affect the administration or interpretation of the Dynamic Visual Acuity Test, including a history of amblyopia, diplopia, or significant visual loss.
- Persistent symptoms related to a previous concussion or traumatic brain injury.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Postural Stabilization Training Group
Participants in this group will receive ankle joint mobilization followed by a structured postural stabilization training program.
The program will include single-leg stance progression, hop stabilization tasks, and number-sequence hop tasks.
Exercises will be progressed according to the participant's ability to complete each task without errors.
Ankle joint mobilization will include talocrural anteroposterior mobilization and distal fibular mobilization with movement, applied before the exercise session for approximately 5 minutes.
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Participants in this group will receive ankle joint mobilization followed by a structured postural stabilization training program.
The program will include single-leg stance progression, hop stabilization tasks and number-sequence hop tasks.
Exercises will be progressed according to the participant's ability to complete each task without errors.
Ankle joint mobilization will include talocrural anteroposterior mobilization and distal fibular mobilization with movement, applied before the exercise session for approximately 5 minutes.
The total session will last approximately 45 minutes and will be performed 3 times per week for 6 weeks.
Ostatní jména:
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Experimentální: Vestibulo-Ocular Reflex Exercise in addition to Postural Stabilization Training Group
Participants in this group will receive the same ankle joint mobilization and postural stabilization training program as the Postural Stabilization Training Group.
In addition, vestibulo-ocular reflex (VOR) exercises involving fixation on a visual target during head movements will be implemented.
VOR exercises will be structured to progressively increase postural demands and will include sitting, standing, walking, and single-leg stance positions.
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Participants in this group will receive the same ankle joint mobilization and postural stabilization training program as the Postural Stabilization Training Group.
In addition, vestibulo-ocular reflex (VOR) exercises involving fixation on a visual target during head movements will be implemented.
VOR exercises will be structured to progressively increase postural demands and will include sitting, standing, walking, and single-leg stance positions.
The total session will last approximately 45 minutes and will be performed 3 times per week for 6 weeks.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Reactive Balance Test
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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This test will be used to assess visuo-motor reaction performance during dynamic postural control. The test will combine the Y-Balance Test setup with a smartphone-controlled LED light system (BlazePod). LED targets will be placed at 80% of each participant's maximum reach distance in the anterior, posteromedial, and posterolateral directions. Participants will stand in the standard Y-Balance Test position and will be instructed to touch the target LED stimulus as quickly as possible without losing balance. A total of 45 randomized visual stimuli will be presented, with inter-stimulus intervals ranging from 0.5 to 2.5 seconds. Visuo-motor reaction time will be recorded in milliseconds, and accuracy will be calculated based on missed stimuli, multiple attempts, and decision errors. The test will be performed twice on the limb with a history of instability; the first trial will be used for familiarization, and the second trial will be used for analysis. |
baseline, 6 weeks after baseline, and 10-week after baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Athlete Fear Avoidance Questionnaire - Turkish Version (AFAQ-TR)
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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The questionnaire will be used to assess fear-avoidance behavior related to return to sport after injury. The questionnaire consists of 10 items scored on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The total score ranges from 0 to 40, with higher scores indicating greater fear-avoidance behavior. |
baseline, 6 weeks after baseline, and 10-week after baseline
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The Tampa Scale for Kinesiophobia - Turkish Version (TSK-TR)
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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The scale will be used to assess fear of movement after musculoskeletal injury. The scale consists of 17 items scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). After reverse scoring items 4, 8, 12, and 16, a total score will be calculated. The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. |
baseline, 6 weeks after baseline, and 10-week after baseline
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Weight-Bearing Lunge Test
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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The Weight-Bearing Lunge Test will be used to assess ankle dorsiflexion range of motion in a weight-bearing position.
The maximum distance at which the knee can touch the wall without heel lift will be measured in centimeters.
A dorsiflexion distance on the affected side that is ≥2.5 cm less than the unaffected side will be considered indicative of dorsiflexion limitation.
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baseline, 6 weeks after baseline, and 10-week after baseline
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Foot and Ankle Ability Measure Turkish Version (FAAM-T)
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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The Foot and Ankle Ability Measure Turkish Version (FAAM-T) will be used to evaluate postural stability and foot/anklerelated functional ability following chronic ankle instability and lateral ankle sprain.
The FAAM consists of 29 items and includes two subscales: the Activities of Daily Living subscale (FAAM-ADL, 21 items) and the Sports subscale (FAAMS, 8 items).
The Sports subscale is specifically designed to assess sport-related function and complex motor tasks and is widely used as a self-reported outcome measure in athletic populations.
Scores are expressed as a percentage, with lower scores indicating greater sport-related functional limitation.
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baseline, 6 weeks after baseline, and 10-week after baseline
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Cumberland Ankle Instability Tool - Turkish Version
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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The Cumberland Ankle Instability Tool is a 9-item questionnaire used to evaluate perceived ankle instability and functional limitations. The total score ranges from 0 to 30, with lower scores indicating greater ankle instability. A score of 24 or lower is considered consistent with functional ankle instability. |
baseline, 6 weeks after baseline, and 10-week after baseline
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Dynamic Visual Acuity Test
Časové okno: baseline, 6 weeks after baseline, and 10-week after baseline
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The Dynamic Visual Acuity Test will be used to assess the functional status of the vestibulo-ocular reflex (VOR). Static visual acuity (SVA) and dynamic visual acuity (DVA) during active head movements will be measured, and the difference between these two values will be used as an indicator of VOR function. For both measurements, the smallest line that can be read with at least 50% accuracy will be recorded. The change in the SVA-DVA difference will be reported after the intervention. |
baseline, 6 weeks after baseline, and 10-week after baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mustafa Fatih Çetintaş, PT, PhD (c), Bahçeşehir University
- Studijní židle: Pelin Pişirici, PT, PhD, Bahçeşehir University
- Ředitel studie: Gamze Kılıç, PT, PhD, Istanbul Nisantasi University
- Ředitel studie: Barış Kocaoğlu Kocaoğlu, MD, Acibadem University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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