- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07627165
Effects of Rigid and Kinesio Taping on Balance and Performance in Chronic Ankle Instability (FAST-CAI)
Immediate and Fatigue-Related Effects of Rigid and Kinesio Subtalar Sling Taping on Dynamic Balance, Proprioception, and Functional Performance in Individuals With Chronic Ankle Instability
The goal of this clinical trial is to learn whether rigid subtalar sling taping or kinesio subtalar sling taping can improve balance, proprioception, and functional performance in physically active adults with chronic ankle instability. It will also evaluate whether these taping methods help maintain performance after fatigue.
The main questions it aims to answer are:
- Do rigid and kinesio subtalar sling taping improve dynamic balance compared with sham taping?
- Do rigid and kinesio subtalar sling taping improve ankle joint position sense and functional performance compared with sham taping?
- Which taping method is more effective in preserving performance following a fatigue protocol?
Researchers will compare rigid subtalar sling taping, kinesio subtalar sling taping, and sham taping to determine their effects on balance, proprioception, and functional performance before and after fatigue.
Participants will:
- Complete questionnaires related to ankle instability and sport function.
- Undergo dynamic balance testing using the Y-Balance Test.
- Perform functional performance tests including the Single-Leg Hop Test, Side Hop Test, and Figure-of-8 Hop Test.
- Complete an ankle joint position sense assessment.
- Receive either rigid subtalar sling taping, kinesio subtalar sling taping, or sham taping.
- Perform a standardized fatigue protocol.
- Repeat all outcome assessments immediately after taping, after fatigue, and following a short recovery period.
Přehled studie
Postavení
Podmínky
Detailní popis
Chronic ankle instability (CAI) is a common long-term consequence of lateral ankle sprains and is characterized by recurrent episodes of ankle giving way, sensorimotor deficits, impaired postural control, and reduced functional performance. Individuals with CAI frequently demonstrate deficits in dynamic balance and proprioception, which may increase the risk of recurrent injury and negatively affect sports participation and physical activity.
External ankle support strategies are commonly used in clinical rehabilitation and sports medicine to enhance joint stability and improve functional outcomes. Among these strategies, rigid taping and kinesio taping are widely applied. Rigid taping primarily aims to restrict excessive joint motion and provide mechanical support, whereas kinesio taping is believed to facilitate neuromuscular function through cutaneous stimulation and enhanced sensory feedback. Although previous studies have reported beneficial effects of taping interventions, the comparative effectiveness of these approaches under fatigue conditions remains insufficiently understood.
Fatigue is considered an important factor influencing injury risk because it may impair neuromuscular control, proprioceptive acuity, and postural stability. Since many ankle sprains occur during the later stages of sports participation when fatigue is present, evaluating the effectiveness of taping interventions under fatigue conditions may provide clinically meaningful information for injury prevention and rehabilitation.
This study is designed as a randomized, double-blind, parallel-group controlled trial. Participants will be randomly allocated to receive rigid subtalar sling taping, kinesio subtalar sling taping, or sham taping. Assessments will be conducted at multiple time points to investigate both immediate responses to taping and responses following a standardized fatigue protocol.
The primary objective of the study is to determine whether rigid or kinesio subtalar sling taping can improve sensorimotor and functional characteristics in individuals with chronic ankle instability and whether these effects are maintained following fatigue. The study also aims to compare the relative effectiveness of the two taping approaches and to identify potential advantages of mechanical versus sensorimotor support strategies.
The findings of this trial may contribute to evidence-based decision making regarding taping applications in sports rehabilitation, injury prevention, and return-to-sport management for individuals with chronic ankle instability.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Onur Atakan Sekibağ, PT, MSc, PhD(c)
- Telefonní číslo: +902122101010
- E-mail: onuratakan.sekibag@nisantasi.edu.tr
Studijní místa
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye)
- Istanbul Nisantasi University
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Kontakt:
- Onur Atakan Sekibağ, PT, MSc, PhD(c)
- Telefonní číslo: 902122101010
- E-mail: onuratakan.sekibag@nisantasi.edu.tr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age between 18 and 35 years.
- Physically active individuals participating in physical activity at least three times per week.
- History of at least one significant lateral ankle sprain.
- Self-reported episodes of ankle giving way, recurrent sprains, or feelings of instability during the previous six months.
- Cumberland Ankle Instability Tool (CAIT) score ≤24.
- Ability to understand study procedures and provide written informed consent.
Exclusion Criteria:
- Acute lower-extremity injury within the previous three months.
- Previous lower-extremity fracture requiring surgical management.
- History of lower-extremity surgery.
- Vestibular, neurological, or systemic disorders affecting balance, movement, or proprioception.
- Current musculoskeletal pain that limits participation in testing procedures.
- Known allergy or sensitivity to adhesive tape materials.
- Participation in another rehabilitation or intervention study during the study period.
- Inability to complete the fatigue protocol or functional performance assessments safely.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Rigid Subtalar Sling Taping
Participants will receive rigid subtalar sling taping applied by a trained investigator prior to performance testing and the fatigue protocol.
|
A rigid athletic tape application designed to provide mechanical support to the subtalar and ankle joints and restrict excessive motion associated with chronic ankle instability.
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Experimentální: Kinesio Subtalar Sling Taping
Participants will receive kinesio subtalar sling taping applied by a trained investigator prior to performance testing and the fatigue protocol.
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A kinesiology tape application designed to enhance sensorimotor feedback and improve neuromuscular control without substantially restricting ankle motion.
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Falešný srovnávač: Sham Taping
Participants will receive a sham taping application that does not provide mechanical support or intended sensorimotor facilitation prior to performance testing and the fatigue protocol.
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A placebo taping application intended to mimic taping procedures without providing meaningful mechanical support or sensorimotor enhancement.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Y-Balance Test Composite Score
Časové okno: Baseline, immediately after taping, immediately after fatigue, and after recovery (approximately 30 minutes)
|
Dynamic balance performance measured using the Y-Balance Test composite score.
Changes in composite reach distance will be compared between groups across all assessment time points.
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Baseline, immediately after taping, immediately after fatigue, and after recovery (approximately 30 minutes)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ankle Joint Position Sense Error
Časové okno: Baseline, immediately after taping, immediately after fatigue, and after recovery
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Ankle proprioception assessed by active joint position sense error measured in degrees.
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Baseline, immediately after taping, immediately after fatigue, and after recovery
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Single-Leg Hop Distance
Časové okno: Baseline, immediately after taping, immediately after fatigue, and after recovery
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Functional performance assessed by maximum hop distance during the Single-Leg Hop Test.
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Baseline, immediately after taping, immediately after fatigue, and after recovery
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Side Hop Test Performance
Časové okno: Baseline, immediately after taping, immediately after fatigue, and after recovery
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Functional performance assessed by completion time during the Side Hop Test.
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Baseline, immediately after taping, immediately after fatigue, and after recovery
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Figure-of-8 Hop Test Performance
Časové okno: Baseline, immediately after taping, immediately after fatigue, and after recovery
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Functional performance assessed by completion time during the Figure-of-8 Hop Test.
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Baseline, immediately after taping, immediately after fatigue, and after recovery
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Onur Atakan Sekibağ, PT, MSc, PhD(c), Istanbul Nişantaşı University
Publikace a užitečné odkazy
Obecné publikace
- Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.
- Meng S, Fu X, Xu Y, Zhang X, Peng Z, Cao Y, Tang B, Shi X, Liu K, Zhu J. The effects of kinesio taping on dynamic balance in patients with chronic ankle instability: a systematic review and meta-analysis. Front Physiol. 2026 Apr 27;17:1823162. doi: 10.3389/fphys.2026.1823162. eCollection 2026.
- Wang X, Shao X, Yu R, Wang Y, Deng F, Adams R, Han J. Acute effects of kinesiology tape on dynamic balance control in chronic ankle instability: An exploratory study. Phys Ther Sport. 2023 Jul;62:65-70. doi: 10.1016/j.ptsp.2023.06.005. Epub 2023 Jun 29.
- Powden CJ, Hoch JM, Hoch MC. Rehabilitation and Improvement of Health-Related Quality-of-Life Detriments in Individuals With Chronic Ankle Instability: A Meta-Analysis. J Athl Train. 2017 Aug;52(8):753-765. doi: 10.4085/1062-6050-52.5.01. Epub 2017 Jul 13.
- Wikstrom EA, Brown CN. Minimum reporting standards for copers in chronic ankle instability research. Sports Med. 2014 Feb;44(2):251-68. doi: 10.1007/s40279-013-0111-4.
- Wilkerson GB, Kovaleski JE, Meyer M, Stawiz C. Effects of the subtalar sling ankle taping technique on combined talocrural-subtalar joint motions. Foot Ankle Int. 2005 Mar;26(3):239-46. doi: 10.1177/107110070502600310.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
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
Další identifikační čísla studie
- OASTaping
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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