Chronic Ankle Instability, CAINCT07581535
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
A study testing Exercise in people with Chronic Ankle Instability, CAI, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Ankle Instability, CAI
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2026to 7 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Katip Celebi University Physiotherapy and Rehabilitation Department
Izmir, Çiğli, 35650
Damla Karabay, +902323293535, damla.gulpinar@ikcu.edu.tr
About this study
Official title: 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
Read the 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
- Conditions
- Chronic Ankle Instability, CAI
- Being tested
- Exercise
- Keywords
- Postural Balance, Proprioception, Rehabilitation, Ankle Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
ExerciseOther
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-Balance Test
Dynamic balance performance assessed using balance tests (Y-Balance Test)
Measured: 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.
Measured: Baseline and post-intervention (after 4 weeks)
Secondary outcomes (6)
Ankle Joint Position Error Test
Ankle proprioception assessed using laser beam device joint position error (JPE) tests
Measured: Baseline and post-intervention (after 4 weeks)
Weight Bearing Lunge Test
Ankle dorsiflexion range of motion will be assessed with the weight bearing lunge test
Measured: Baseline and post-intervention (after 4 weeks)
Computerized balance assessment
Postural stability will be assessed using the Prokin Tecnobody balance assessment system.
Measured: Baseline and post-intervention (after 4 weeks)
Side Hop Test
Side hop test will be used to assess the dynamic postural control capacity around the ankle.
Measured: Baseline and post-intervention (after 4 weeks)
Ankle Pain
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.
Measured: Baseline and post-intervention (after 4 weeks)
Cervical Joint Position Error Test
Cervical proprioception will be assessed using the Cervical Joint Position Error Test.
Measured: Baseline and post-intervention (after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start7 Jun 2026 (estimated)
- Primary completion7 Jun 2027 (estimated)
- Study completion7 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Bakircay University
- Responsible party
- Principal investigator, Simge Nur UNGAN, Izmir Katip Celebi University
- Investigators
- Damla KARABAY, Assistant Professor, Study chair, Izmir Katip Çelebi UniversitySimge N UNGAN, Physiotherapist (Bachelor), Principal investigator, Izmir Katip Çelebi UniversitySercan Çapkın, Associate Professor, Study director, Izmir Bakırçay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581535
- Sponsor's protocol ID
- 2586
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07581535
- Acronym / sponsor ID
- 2586
- Conditions
- Chronic Ankle Instability, CAI
- Keywords
- Postural Balance, Proprioception, Rehabilitation, Ankle Instability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Izmir Bakircay University
- Study start
- 7 Jun 2026 (estimated)
- Primary completion
- 7 Jun 2027 (estimated)
- Study completion
- 7 Jun 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment + Cervical and Oculomotor Exercises | Experimental | Other: ExerciseParticipants 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. |
| Conventional Treatment | Active comparator | Other: ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants 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 | Conventional Treatment + Cervical and Oculomotor Exercises |
| ExerciseParticipants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. | Other | Conventional Treatment |
Primary outcome
Y-Balance Test
Time frame: Baseline and post-intervention (after 4 weeks)
Dynamic balance performance assessed using balance tests (Y-Balance Test)
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.
6 secondary outcomes
Ankle Joint Position Error Test
Time frame: Baseline and post-intervention (after 4 weeks)
Weight Bearing Lunge Test
Time frame: Baseline and post-intervention (after 4 weeks)
Computerized balance assessment
Time frame: Baseline and post-intervention (after 4 weeks)
Side Hop Test
Time frame: Baseline and post-intervention (after 4 weeks)
Ankle Pain
Time frame: Baseline and post-intervention (after 4 weeks)
Cervical Joint Position Error Test
Time frame: Baseline and post-intervention (after 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Chronic Ankle Instability, CAI
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
Ankle vs. Hip vs. Combined Strengthening in Chronic Ankle Instability
Chronic Ankle Instability, CAI, Ankle Sprain
Not yet recruiting
Lower Extremity Mobility for CAI
Chronic Ankle Instability, CAI
Not yet recruitingObservational study
The Effect of Cognitive Dual-Task on Athletic Performance Parameters in Volleyball Players With and Without Chronic Ankle Instability
Chronic Ankle Instability, Chronic Ankle Instability, CAI
Active, not recruitingObservational study
Postural Control in Amateur Footballers With Chronic Ankle Instability
Chronic Ankle Instability, CAI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damla KARABAY, Assistant Professor study chair
Izmir Katip Çelebi University
Simge N UNGAN, Physiotherapist (Bachelor) principal investigator
Izmir Katip Çelebi University
Sercan Çapkın, Associate Professor study director
Izmir Bakırçay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Ankle Instability, CAI, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simge N UNGAN, Phsiotherapist (+90 507 648 5776, ungansimgenur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Y-Balance Test (time frame: Baseline and post-intervention (after 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.