NCT07581535

Brief Summary

Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress4%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 29, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

April 29, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Postural BalanceProprioceptionRehabilitationAnkle Instability

Outcome Measures

Primary Outcomes (2)

  • Y-Balance Test

    Dynamic balance performance assessed using balance tests (Y-Balance Test)

    Baseline and post-intervention (after 4 weeks)

  • Foot and Ankle Ability Measure (FAAM)

    Functional status assessed using the Foot and Ankle Ability Measure (FAAM) The daily living activities subscale contains 21 items; the minimum score is 0 and the maximum score is 84. The sports subscale consists of 8 items; the minimum score is 0 and the maximum score is 32. A higher score represents a higher level of physical function.

    Baseline and post-intervention (after 4 weeks)

Secondary Outcomes (6)

  • Ankle Joint Position Error Test

    Baseline and post-intervention (after 4 weeks)

  • Weight Bearing Lunge Test

    Baseline and post-intervention (after 4 weeks)

  • Computerized balance assessment

    Baseline and post-intervention (after 4 weeks)

  • Side Hop Test

    Baseline and post-intervention (after 4 weeks)

  • Ankle Pain

    Baseline and post-intervention (after 4 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Conventional Treatment + Cervical and Oculomotor Exercises

EXPERIMENTAL

Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. In addition, they will perform cervical stabilization and oculomotor exercises. The intervention will be conducted for 4 weeks, with 3 sessions per week. Participants will follow a home exercise program that includes ankle mobility, strengthening, balance, and oculomotor exercises on days when they do not attend the clinic.

Other: Exercise

Conventional Treatment

ACTIVE COMPARATOR

Participants in the control group will receive a conventional rehabilitation program consisting of mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. The intervention will be conducted for 4 weeks, with 3 sessions per week. Participants will follow a home exercise program that includes ankle mobility, strengthening and balance exercises on days when they do not attend the clinic.

Other: Exercise

Interventions

Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. In addition, they will perform cervical stabilization and oculomotor exercises.

Conventional Treatment + Cervical and Oculomotor Exercises

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with unilateral chronic ankle instability (CAI) in accordance with the International Ankle Consortium recommendations
  • A history of at least one significant lateral ankle sprain that occurred at least 12 months prior to participation, resulting in inflammatory symptoms such as pain and swelling and causing at least one day of interruption in physical activity
  • A history of "giving way" and/or recurrent ankle sprains and/or a feeling of instability in the affected ankle within the past 6 months
  • A Cumberland Ankle Instability Tool (CAIT) score of ≤ 25

You may not qualify if:

  • History of surgery or fracture in the lower extremities or spine
  • Acute musculoskeletal injury affecting other joints of the lower extremity within the past 3 months (e.g., sprains, fractures) that impaired joint integrity and function and caused at least one day of interruption in physical activity
  • History of injection in the affected ankle
  • History of ankle sprain in the affected extremity within the past 4 weeks
  • Presence of systemic musculoskeletal disorders, neurological disorders, vestibular disorders, or any other condition that may affect balance or sensory function
  • Previous participation in any rehabilitation program for the ankle or cervical region
  • History of head or neck trauma or diagnosed pathology within the past 12 months
  • History of neck pain greater than 3/10 in severity within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Physiotherapy and Rehabilitation Department

Izmir, Çiğli, 35650, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Damla KARABAY, Assistant Professor

    Izmir Katip Çelebi University

    STUDY CHAIR
  • Simge N UNGAN, Physiotherapist (Bachelor)

    Izmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR
  • Sercan Çapkın, Associate Professor

    Izmir Bakırçay University

    STUDY DIRECTOR

Central Study Contacts

Simge N UNGAN, Phsiotherapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phsiotherapist

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 12, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

June 7, 2027

Study Completion (Estimated)

June 7, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations