- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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 evaluate the immediate effects of rigid subtalar sling taping, kinesio subtalar sling taping, and sham taping on balance, proprioception, ankle mobility, and functional performance in physically active adults with chronic ankle instability.
The main questions it aims to answer are:
- Does rigid subtalar sling taping improve dynamic balance, ankle proprioception, ankle dorsiflexion mobility, and functional performance in individuals with chronic ankle instability?
- Does rigid subtalar sling taping provide greater benefits than kinesio subtalar sling taping or sham taping under fatigue and recovery conditions?
Researchers will compare rigid subtalar sling taping, kinesio subtalar sling taping, and sham taping to determine their effects on balance, proprioception, ankle mobility, and functional performance before fatigue, after fatigue, and following recovery.
Participants will:
- Complete baseline assessments of dynamic balance, ankle proprioception, ankle dorsiflexion mobility, and functional performance.
- Be randomly assigned to receive rigid subtalar sling taping, kinesio subtalar sling taping, or sham taping.
- Repeat all outcome assessments immediately after tape application.
- Perform a standardized fatigue protocol consisting of running, hopping, jumping, and heel-raise exercises until predefined fatigue criteria are reached.
- Complete all outcome assessments immediately after the fatigue protocol.
- Rest in a seated position for 20 minutes.
- Complete a final set of outcome assessments following recovery.
The study aims to identify whether subtalar sling taping can improve functional performance and neuromuscular control in physically active individuals with chronic ankle instability and whether these effects are maintained after fatigue and recovery.
연구 개요
상태
상세 설명
Chronic ankle instability (CAI) is a common long-term consequence of lateral ankle sprains and is characterized by recurrent episodes of ankle giving way, impaired sensorimotor control, reduced dynamic balance, and functional limitations during physical activity. Persistent deficits in proprioception, postural control, and movement performance may increase the risk of recurrent injury and negatively affect participation in sports and recreational activities.
External ankle support strategies are frequently used to improve stability and reduce the risk of recurrent ankle sprains. Among these strategies, rigid taping and kinesio taping are widely applied in both rehabilitation and sports settings. Rigid taping is primarily intended to provide mechanical support and limit excessive joint motion, whereas kinesio taping is believed to enhance sensorimotor function through cutaneous stimulation and improved neuromuscular feedback. Despite their widespread use, evidence regarding their comparative effectiveness remains inconsistent, particularly under fatigue conditions.
Fatigue is considered an important contributor to injury risk because it may impair proprioception, dynamic balance, joint stability, and functional performance. Since many ankle sprains occur during the later stages of physical activity when fatigue is present, understanding whether taping interventions can preserve performance under fatigue may have important implications for injury prevention and rehabilitation.
This randomized controlled trial was designed to compare the immediate and fatigue-related effects of rigid subtalar sling taping, kinesio subtalar sling taping, and sham taping in physically active individuals with chronic ankle instability. Assessments were performed before intervention, immediately after tape application, following a standardized fatigue protocol, and after a recovery period to evaluate both immediate responses and the ability of the interventions to maintain performance under physiologically demanding conditions.
The findings of this study may contribute to evidence-based recommendations regarding taping applications for individuals with chronic ankle instability and may help clinicians select appropriate external support strategies during rehabilitation, return-to-sport decision-making, and injury prevention programs.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye)
- Istanbul Nisantasi University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Rigid Subtalar Sling Taping
Participants will receive rigid subtalar sling taping applied by a trained investigator prior to performance testing and the fatigue protocol.
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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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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Y-Balance Test Composite Score
기간: Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Dynamic balance performance assessed using the Y-Balance Test (YBT) Composite Score.
The composite score is calculated as the sum of the anterior, posteromedial, and posterolateral reach distances divided by three times the participant's leg length and multiplied by 100.
Scores are expressed as a percentage, with higher scores indicating better dynamic balance performance.
There is no fixed minimum or maximum score, although values typically range between 0 and 100%.
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Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Ankle Joint Position Sense Error
기간: Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Ankle proprioception assessed using active ankle Joint Position Sense (JPS) error measured in degrees (°).
The outcome represents the absolute difference between the target angle and the reproduced angle.
The minimum possible value is 0°, with lower values indicating better proprioceptive accuracy and higher values indicating worse proprioceptive performance.
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Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Weight-Bearing Lunge Test Distance
기간: Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Ankle dorsiflexion range of motion assessed using the Weight-Bearing Lunge Test (WBLT).
The maximum distance (cm) from the great toe to the wall while maintaining heel contact with the ground is recorded.
Higher values indicate greater ankle dorsiflexion mobility.
There is no fixed maximum value.
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Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Single-Leg Hop Distance
기간: Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Functional performance assessed using the Single-Leg Hop Test.
The maximum forward hop distance is measured in centimeters (cm).
Higher values indicate better functional performance.
There is no fixed maximum value.
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Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Side Hop Test Performance
기간: Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Functional performance assessed using the Side Hop Test.
The total time required to complete the test is recorded in seconds (s).
Lower values indicate better performance.
There is no fixed maximum value.
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Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Figure-of-8 Hop Test Performance
기간: Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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Functional performance assessed using the Figure-of-8 Hop Test.
The total completion time is recorded in seconds (s).
Lower values indicate better functional performance.
There is no fixed maximum value.
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Baseline, immediately after taping, immediately after the fatigue protocol, and 20 minutes after completion of the fatigue protocol.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Borg Rating of Perceived Exertion
기간: Immediately after completion of the fatigue protocol.
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Perceived exertion measured immediately following the fatigue protocol using the Borg Rating of Perceived Exertion Scale.
Scores range from 6 to 20, with higher scores indicating greater perceived exertion.
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Immediately after completion of the fatigue protocol.
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Post-Fatigue Heart Rate
기간: Immediately after completion of the fatigue protocol.
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Heart rate measured immediately following completion of the fatigue protocol using a wearable heart rate monitor and expressed in beats per minute (bpm).
Higher values indicate greater cardiovascular response to exercise.
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Immediately after completion of the fatigue protocol.
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Fatigue Protocol Duration
기간: Immediately after completion of the fatigue protocol.
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Total duration required to complete the fatigue protocol, recorded in seconds.
Longer durations indicate greater time required to reach the predefined fatigue criteria.
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Immediately after completion of the fatigue protocol.
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Number of Fatigue Protocol Rounds
기간: Immediately after completion of the fatigue protocol.
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Total number of completed fatigue protocol circuits performed before reaching the predefined fatigue criteria.
Higher values indicate a greater number of completed circuits.
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Immediately after completion of the fatigue protocol.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Onur Atakan Sekibağ, PT, MSc, PhD(c), Istanbul Nişantaşı University
간행물 및 유용한 링크
일반 간행물
- 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.
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
- OASTaping
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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