- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581535
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
May 6, 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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
38
Phase
- 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
- Name: Simge N UNGAN, Phsiotherapist
- Phone Number: +90 507 648 5776
- Email: ungansimgenur@gmail.com
Study Locations
-
-
Çiğli
-
Izmir, Çiğli, Turkey (Türkiye), 35650
- Izmir Katip Celebi University Physiotherapy and Rehabilitation Department
-
Contact:
- Damla Karabay
- Phone Number: +902323293535
- Email: damla.gulpinar@ikcu.edu.tr
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
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.
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
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
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
Collaborators
Investigators
- Study Chair: Damla KARABAY, Assistant Professor, Izmir Katip Çelebi University
- Principal Investigator: Simge N UNGAN, Physiotherapist (Bachelor), Izmir Katip Çelebi University
- Study Director: Sercan Çapkın, Associate Professor, Izmir 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)
May 7, 2026
Primary Completion (Estimated)
June 7, 2027
Study Completion (Estimated)
June 7, 2027
Study Registration Dates
First Submitted
April 29, 2026
First Submitted That Met QC Criteria
May 6, 2026
First Posted (Actual)
May 12, 2026
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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