NCT07760233

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Jul 2027

Study Start

First participant enrolled

July 25, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2027

Last Updated

August 12, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

sprainsensory reweightinginjury-related anxietypsychological readinessgaze stabilization

Outcome Measures

Primary Outcomes (1)

  • Reactive Balance Test

    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

Secondary Outcomes (2)

  • The Athlete Fear Avoidance Questionnaire - Turkish Version (AFAQ-TR)

    baseline, 6 weeks after baseline, and 10-week after baseline

  • The Tampa Scale for Kinesiophobia - Turkish Version (TSK-TR)

    baseline, 6 weeks after baseline, and 10-week after baseline

Other Outcomes (4)

  • Foot and Ankle Ability Measure Turkish Version (FAAM-T)

    baseline, 6 weeks after baseline, and 10-week after baseline

  • Cumberland Ankle Instability Tool - Turkish Version

    baseline, 6 weeks after baseline, and 10-week after baseline

  • Weight-Bearing Lunge Test

    baseline, 6 weeks after baseline, and 10-week after baseline

  • +1 more other outcomes

Study Arms (2)

Postural Stabilization Training Group

ACTIVE COMPARATOR

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.

Other: Postural Stabilization Training

Vestibulo-Ocular Reflex Exercise in addition to Postural Stabilization Training Group

EXPERIMENTAL

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.

Other: Vestibulo-Ocular Reflex Exercise in addition to Postural Stabilization Training

Interventions

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.

Also known as: Talocrural joint mobilization
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. The total session will last approximately 45 minutes and will be performed 3 times per week for 6 weeks.

Also known as: Talocrural joint mobilization
Vestibulo-Ocular Reflex Exercise in addition to Postural Stabilization Training Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reset Fizyoterapi

Istanbul, Turkey, 34728, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ankle InjuriesSprains and Strains

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Mustafa Fatih Çetintaş, PT, PhD (c)

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR
  • Pelin Pişirici, PT, PhD

    Bahçeşehir University

    STUDY CHAIR
  • Gamze Kılıç, PT, PhD

    Istanbul Nisantasi University

    STUDY DIRECTOR
  • Barış Kocaoğlu Kocaoğlu, MD

    Acibadem University

    STUDY DIRECTOR

Central Study Contacts

Mustafa Fatih Çetintaş, PT, PhD (c)

CONTACT

Pelin Pişirici, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants who meet the inclusion criteria will be randomized into Participants will be randomly allocated to one of two groups two parallel groups: Postural Stabilization Training Group and Postural Stabilization Training plus Vestibulo-Ocular Reflex Exercises Group. Both groups will receive the ankle joint mobilization by the same physiotherapist. Assessments will be performed at baseline, at the end of week 6, and at 4-week follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD (c)

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start

July 25, 2026

Primary Completion (Estimated)

July 25, 2027

Study Completion (Estimated)

July 25, 2027

Last Updated

August 12, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations