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

June 4, 2026 updated by: Simge Nur UNGAN, Izmir Katip Celebi University

Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals With Chronic Ankle Instability: A Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals with Chronic Ankle Instability: A Randomized Controlled Trial

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Çiğli
      • Izmir, Çiğli, Turkey (Türkiye), 35650
        • Recruiting
        • Izmir Katip Celebi University Physiotherapy and Rehabilitation Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conventional Treatment + Cervical and Oculomotor Exercises
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
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.
Other: Exercise
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
Active Comparator: Conventional Treatment
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
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.
Other: Exercise
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Y-Balance Test
Time Frame: Baseline and post-intervention (after 4 weeks)
Dynamic balance performance assessed using balance tests (Y-Balance Test)
Baseline and post-intervention (after 4 weeks)
Foot and Ankle Ability Measure (FAAM)
Time Frame: Baseline and post-intervention (after 4 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ankle Joint Position Error Test
Time Frame: Baseline and post-intervention (after 4 weeks)
Ankle proprioception assessed using laser beam device joint position error (JPE) tests
Baseline and post-intervention (after 4 weeks)
Weight Bearing Lunge Test
Time Frame: Baseline and post-intervention (after 4 weeks)
Ankle dorsiflexion range of motion will be assessed with the weight bearing lunge test
Baseline and post-intervention (after 4 weeks)
Computerized balance assessment
Time Frame: Baseline and post-intervention (after 4 weeks)
Postural stability will be assessed using the Prokin Tecnobody balance assessment system.
Baseline and post-intervention (after 4 weeks)
Side Hop Test
Time Frame: Baseline and post-intervention (after 4 weeks)
Side hop test will be used to assess the dynamic postural control capacity around the ankle.
Baseline and post-intervention (after 4 weeks)
Ankle Pain
Time Frame: Baseline and post-intervention (after 4 weeks)
Ankle pain will be assessed using a visual analog scale (VAS). The VAS is a scale ranging from 0 (no pain) to 10 (most severe pain), with higher scores indicating greater pain.
Baseline and post-intervention (after 4 weeks)
Cervical Joint Position Error Test
Time Frame: Baseline and post-intervention (after 4 weeks)
Cervical proprioception will be assessed using the Cervical Joint Position Error Test.
Baseline and post-intervention (after 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Katip Celebi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Izmir Bakircay University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Damla KARABAY, Assistant Professor, Izmir Katip Celebi University
  • Principal Investigator: Simge N UNGAN, Physiotherapist (Bachelor), Izmir Katip Celebi University
  • Study Director: Sercan Çapkın, Associate Professor, İzmir Bakırçay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2586

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A final decision regarding the sharing of individual participant data has not yet been made due to considerations related to data protection regulations. If a decision to share is made in the future, only de-identified data relevant to the published results may be shared upon reasonable request and in accordance with applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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