Ankle OsteoarthritisNCT07417436
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
A study testing Exercise Program and Exercise plus graded motor imagery in people with Ankle Osteoarthritis and Foot Osteoarthritis, run by Alanya Alaaddin Keykubat University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of our study is to evaluate the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Osteoarthritis, Foot Osteoarthritis
- What is being tested?
- Exercise Program and Exercise plus graded motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older,
- Have a diagnosis of foot and/or ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination
- Experience pain in the ankle joint most days for at least three months
- Agree to participate in randomly assigned treatment and follow-up measurements
- Have sufficient understanding of the Turkish language
- Have a Standardized Mini Mental Test score of at least 24 points
Who cannot join
- Previous arthrodesis or joint replacement surgery on the affected ankle,
- Having received physical therapy for ankle osteoarthritis within the last three months
- Presence of vision or hearing problems that may affect compliance with treatment.
- Presence of a neuromuscular disease
- History of intra-articular ankle injections within the last 3 months
- Initiation of a new disease-specific pharmacological treatment during the study period
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Alanya Alaaddin Keykubat University Training and Research Hospital
Antalya, Antalya
Özlem Nur Tok Yaman, PT, PhD Candidate, +90-537-9379479, ozlem.tok@alanya.edu.tr
- Recruiting
Alanya Alaaddin Keykubat University Training and Research Hospital
Antalya
Özlem Nur Tok Yaman, PT, PhD Candidate, +90-537-9379479, ozlem.tok@alanya.edu.tr
About this study
Official title: Effectiveness of Graded Motor Imagery Training in Individuals With Foot/Ankle Osteoarthritis: A Randomized Controlled Trial
The aim of our study is to evaluate the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis.
The study population will consist of twenty-four individuals diagnosed with foot/ankle osteoarthritis who applied to the Orthopedics and Traumatology Department of Alanya Alaaddin Keykubat University Education and Research Hospital.
Read more
Individuals who volunteer to participate in the study will be invited to participate through face-to-face interviews. The inclusion and exclusion criteria are as follows:
Inclusion criteria:
- Being 18 years of age or older
- Having a diagnosis of foot/ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination
- Experiencing pain in the ankle joint most days for at least three months
- Agreeing to participate in randomly assigned treatment and follow-up measurements
- Having a sufficient level of Turkish language comprehension
- Having a Standardized Mini Mental Test score of at least 24 points
Exclusion criteria:
- Previous arthrodesis or joint replacement surgery on the affected ankle
- Physical therapy for ankle osteoarthritis within the last three months
- Vision or hearing problems that would affect compliance with treatment.
- Presence of a neuromuscular disease
- History of intra-articular ankle injections within the last 3 months
- Initiation of a new disease-specific pharmacological treatment during the study period During the study period, participants will receive one of the physical therapy programs. One group will only participate in the structured exercise program, while the other group will receive graded motor imagery training in addition to the exercise program.Both treatment groups will receive a total of 12 treatment sessions over 6 weeks.
The results of this study may help improve physiotherapy programs for individuals with similar health conditions.
- Conditions
- Ankle Osteoarthritis, Foot Osteoarthritis
- Being tested
- Exercise Program, Exercise plus graded motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
During this intervention, participants will take part in a structured physiotherapy exercise program. The program will be delivered under the guidance of a physiotherapist.
Exercise plus graded motor imageryBehavioural
During this intervention, participants will take part in the same physiotherapy exercise program combined with educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Active comparator | Not described Receives: Behavioral: Exercise Program |
| Exercise and graded motor imagery | Active comparator | Not described Receives: Behavioral: Exercise plus graded motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic assessment form
The names, ages, genders, heights, body weights, dominant side of the lower extremity, occupations, education levels, and medication use of individuals who wish to participate in the study on a voluntary basis will be recorded, along with their phone numbers so that they can be contacted again if necessary. Radiological findings, age, and disease duration will also be included in the clinical evaluation form for individuals with foot/ankle osteoarthritis.
Measured: Baseline and after 6 weeks
Pain Intensity Assessment
Patients' rest, activity, and night pain will be assessed using the Numerical Rating Pain Scale (NPRS). The NPRS is an 11-point scale scored from 0 to 10. A score of zero (0) indicates "no pain," while a score of 10 indicates "the most severe pain imaginable." Participants will be asked to mark the appropriate score on this scale for their foot/ankle pain.
Measured: Baseline and after 6 weeks
Pain Threshold Measurement
In this study, the pressure pain threshold (PPT) is defined as the amount of pressure (kg/cm²) at which pressure sensation is converted into pain. PPT measurements will be performed using a mechanical pressure algometer (Commander™ Algometer, JTECH Medical, Inc.). During the measurements, participants will be asked to verbally inform the tester when the applied pressure first causes pain. The device used has a force gauge that measures force in kilograms (kg) and a round rubber tip with a diameter of 1 cm². Pressure application will be performed at a rate of approximately 0.1 kg/cm²/s. Three repetitions will be performed for each anatomical region, and the average of the measurements will be used in the analyses. A 30-second rest period will be provided between each measurement.
During foot measurements, participants will be placed in a long sitting position, and the foot being evaluated will be stabilized by the examiner. Referencing Cavanagh (1987), pressure will be applied to the m
Measured: Baseline and after 6 weeks
Gait Analysis
The BTS G-Walk® Spatio-Temporal Gait Analysis System will be used for gait analysis in the study. Measurements will be performed on a predetermined 10-meter flat walking track . The BTS G-Walk® system works with a wireless sensor (analysis port) placed at the patient's L4-L5 or L5-S1 vertebra level via an elastic belt, and measurement data is transferred to the computer via a Bluetooth connection. This system allows clinicians to analyze spatio-temporal walking parameters obtained during walking, general walking kinematics, and pelvic and spinal movements in three planes. The BTS G-Walk® system provides a detailed analysis by comparing data from the right and left lower extremities with normative values during gait analysis and ensures reliable measurements
Measured: Baseline and after 6 weeks
Foot Function Index
The Foot Function Index is a self-administered questionnaire that assesses multiple dimensions of foot function. The FFI consists of 23 items divided into three subscales that measure the impact of foot pathology on pain, disability, and activity limitation. The minimum change of clinical significance is 7 points for the total scale. The Foot Function Index is widely used in various pathologies and treatments related to foot and ankle problems, such as congenital, acute and chronic diseases, injuries, and surgical corrections .
Measured: Baseline and after 6 weeks
Laterality assessment
Laterization assessment will be performed using the Recognise™ application developed by the Neuro Orthopaedic Institute (NOI). There are versions specific to different parts of the body. The "Recognise™ Foot" application will be used in this thesis study. Using the "Vanilla" mode of the NOI program, foot photos will be presented to participants in random order via their phones. Participants will be asked to indicate whether the image shown belongs to the right or left foot. Both response accuracy and reaction time will be recorded during this assessment. Accuracy will be defined as the percentage of images correctly identified; reaction time will represent the time taken by the participant to distinguish between the right and left foot. If participants cannot respond within 5 seconds to four or more consecutive images, this will be considered inattention, and the test will be repeated. The lateralization assessment will be performed three times for each participant, and the avera
Measured: Baseline and after 6 weeks
Secondary outcomes (6)
Joint position sense assessment
In this study, a universal goniometer, a method recognized in the literature as valid and reliable for Ankle Joint Position Sense (AJPS) assessment, will be used. During the assessment, individuals will be placed in a supine position and their eyes will be closed to eliminate visual cues. The pivot of the goniometer will be placed 1.5 cm below the lateral malleolus, the fixed arm will be parallel to the long axis of the fibula, and the movable arm will be parallel to the long axis of the 5th metatarsal. During this measurement, the goniometer will not come into contact with the individual. During the test, three target angles will be selected from the 10° dorsiflexion, 10° plantar flexion, and 20° plantar flexion angles, which are frequently used in the literature and are important for walking function. The subjects' feet in the neutral position will be brought to the specified target angles, and they will be asked to focus on their ankle positions for 5 seconds. This process will be
Measured: Baseline and after 6 weeks
Foot Pressure Assessment
Measurements will be taken using a pedobarography device to assess foot pressure in a static position. Participants will be given detailed information about the procedure and the measurement process will be explained prior to the measurement. To help participants maintain their balance and focus their attention during the measurement, a point will be marked on the wall three meters ahead, and participants will be asked to focus on this point throughout the measurement. The data displayed on the device screen when participants achieve their balance position will be recorded. As part of the evaluation, the following data will be recorded for analysis: total foot pressure, forefoot pressure, rearfoot pressure , and surface area for the dominant and non-dominant sides.
Measured: Baseline and after 6 weeks
Kinesiophobia Assessment
The Tampa Kinesiophobia Scale (TKS) will be used in the kinesiophobia assessment. The TKS is a 17-item measure consisting of questions related to fear of re-injury, pain anxiety, and fear-avoidance behaviors. Each item is scored using a 4-point Likert scale ranging from 1 to 4, but items 4, 8, 12, and 16 are reverse-scored. The total score ranges from 17 to 68 points; higher scores indicate a higher level of kinesiophobia.
Measured: Baseline and after 6 weeks
Quality of Life Assessment
The Nottingham Health Profile (NHP) will be used to assess participants' health-related quality of life. It is a measure developed to assess an individual's health status in terms of physical, emotional, and social aspects.
The questionnaire assesses six dimensions related to health status: pain (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), sleep (5 items), and physical activity (8 items). It consists of a total of 38 questions answered as yes (1 point)/no (0 points) (Appendix-6). A score between 0 and 100 can be obtained from each subcategory. '0' indicates no limitation, while '100' indicates the presence of all listed limitations.
Measured: Baseline and after 6 weeks
Patient Satisfaction Assessment
The Global Rating of Change (GRC) scale will be used for patient satisfaction assessment. This scale will be used to measure the effect of the treatment process on participants' overall health status and the level to which their individual expectations are met. Participants will be asked to indicate the change they feel in their health status after treatment compared to before treatment.
Measured: End of the intervention
Central Sensitization Assessment
The central sensitization assessment will be conducted using the Central Sensitization Inventory (CSI). This inventory is an assessment tool used to identify individuals with symptoms related to central sensitization and to screen for clinical conditions associated with central sensitization syndrome (CSS), such as fibromyalgia, temporomandibular joint disorder, tension-type headache, and migraine. The CSI consists of two sections: Section A consists of 25 items that inquire about symptoms specific to central sensitization syndrome. Participants rate each item on a scale of 0 to 4. The total score obtained from this section ranges from 0 to 100, with scores of 40 and above indicating the presence of central sensitization. Section B contains questions aimed at determining whether the participant has previously been diagnosed with psychiatric conditions such as anxiety or depression, or with diseases associated with the CNS.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start10 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÖZLEM NUR TOK YAMAN, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417436
- Sponsor's protocol ID
- PAU-KAEK-2025-15
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Graded Motor Imagery Training in Individuals With Foot/Ankle Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07417436
- Acronym / sponsor ID
- PAU-KAEK-2025-15
- Conditions
- Ankle Osteoarthritis, Foot Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Feb 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.
The aim of our study is to evaluate the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis.
The study population will consist of twenty-four individuals diagnosed with foot/ankle osteoarthritis who applied to the Orthopedics and Traumatology Department of Alanya Alaaddin Keykubat University Education and Research Hospital.
Individuals who volunteer to participate in the study will be invited to participate through face-to-face interviews. The inclusion and exclusion criteria are as follows:
Inclusion criteria:
- Being 18 years of age or older
- Having a diagnosis of foot/ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination
- Experiencing pain in the ankle joint most days for at least three months
- Agreeing to participate in randomly assigned treatment and follow-up measurements
- Having a sufficient level of Turkish language comprehension
- Having a Standardized Mini Mental Test score of at least 24 points
Exclusion criteria:
- Previous arthrodesis or joint replacement surgery on the affected ankle
- Physical therapy for ankle osteoarthritis within the last three months
- Vision or hearing problems that would affect compliance with treatment.
- Presence of a neuromuscular disease
- History of intra-articular ankle injections within the last 3 months
- Initiation of a new disease-specific pharmacological treatment during the study period During the study period, participants will receive one of the physical therapy programs. One group will only participate in the structured exercise program, while the other group will receive graded motor imagery training in addition to the exercise program.Both treatment groups will receive a total of 12 treatment sessions over 6 weeks.
The results of this study may help improve physiotherapy programs for individuals with similar health conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Active comparator | Behavioral: Exercise Program |
| Exercise and graded motor imagery | Active comparator | Behavioral: Exercise plus graded motor imagery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or older,
- Have a diagnosis of foot and/or ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination
- Experience pain in the ankle joint most days for at least three months
- Agree to participate in randomly assigned treatment and follow-up measurements
- Have sufficient understanding of the Turkish language
Key exclusion criteria (6 listed)
- Previous arthrodesis or joint replacement surgery on the affected ankle,
- Having received physical therapy for ankle osteoarthritis within the last three months
- Presence of vision or hearing problems that may affect compliance with treatment.
- Presence of a neuromuscular disease
- History of intra-articular ankle injections within the last 3 months
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 |
|---|---|---|
| Exercise ProgramDuring this intervention, participants will take part in a structured physiotherapy exercise program. The program will be delivered under the guidance of a physiotherapist. | Behavioural | Exercise Program |
| Exercise plus graded motor imageryDuring this intervention, participants will take part in the same physiotherapy exercise program combined with educational sessions. | Behavioural | Exercise and graded motor imagery |
Primary outcome
Socio-demographic assessment form
Time frame: Baseline and after 6 weeks
The names, ages, genders, heights, body weights, dominant side of the lower extremity, occupations, education levels, and medication use of individuals who wish to participate in the study on a voluntary basis will be recorded, along with their phone numbers so that they can be contacted again if necessary. Radiological findings, age, and disease duration will also be included in the clinical evaluation form for individuals with foot/ankle osteoarthritis.
Pain Intensity Assessment
Time frame: Baseline and after 6 weeks
Patients' rest, activity, and night pain will be assessed using the Numerical Rating Pain Scale (NPRS). The NPRS is an 11-point scale scored from 0 to 10. A score of zero (0) indicates "no pain," while a score of 10 indicates "the most severe pain imaginable." Participants will be asked to mark the appropriate score on this scale for their foot/ankle pain.
Pain Threshold Measurement
Time frame: Baseline and after 6 weeks
In this study, the pressure pain threshold (PPT) is defined as the amount of pressure (kg/cm²) at which pressure sensation is converted into pain. PPT measurements will be performed using a mechanical pressure algometer (Commander™ Algometer, JTECH Medical, Inc.). During the measurements, participants will be asked to verbally inform the tester when the applied pressure first causes pain. The device used has a force gauge that measures force in kilograms (kg) and a round rubber tip with a diameter of 1 cm². Pressure application will be performed at a rate of approximately 0.1 kg/cm²/s. Three repetitions will be performed for each anatomical region, and the average of the measurements will be used in the analyses. A 30-second rest period will be provided between each measurement. During foot measurements, participants will be placed in a long sitting position, and the foot being evaluated will be stabilized by the examiner. Referencing Cavanagh (1987), pressure will be applied to the m
Gait Analysis
Time frame: Baseline and after 6 weeks
The BTS G-Walk® Spatio-Temporal Gait Analysis System will be used for gait analysis in the study. Measurements will be performed on a predetermined 10-meter flat walking track . The BTS G-Walk® system works with a wireless sensor (analysis port) placed at the patient's L4-L5 or L5-S1 vertebra level via an elastic belt, and measurement data is transferred to the computer via a Bluetooth connection. This system allows clinicians to analyze spatio-temporal walking parameters obtained during walking, general walking kinematics, and pelvic and spinal movements in three planes. The BTS G-Walk® system provides a detailed analysis by comparing data from the right and left lower extremities with normative values during gait analysis and ensures reliable measurements
Foot Function Index
Time frame: Baseline and after 6 weeks
The Foot Function Index is a self-administered questionnaire that assesses multiple dimensions of foot function. The FFI consists of 23 items divided into three subscales that measure the impact of foot pathology on pain, disability, and activity limitation. The minimum change of clinical significance is 7 points for the total scale. The Foot Function Index is widely used in various pathologies and treatments related to foot and ankle problems, such as congenital, acute and chronic diseases, injuries, and surgical corrections .
Laterality assessment
Time frame: Baseline and after 6 weeks
Laterization assessment will be performed using the Recognise™ application developed by the Neuro Orthopaedic Institute (NOI). There are versions specific to different parts of the body. The "Recognise™ Foot" application will be used in this thesis study. Using the "Vanilla" mode of the NOI program, foot photos will be presented to participants in random order via their phones. Participants will be asked to indicate whether the image shown belongs to the right or left foot. Both response accuracy and reaction time will be recorded during this assessment. Accuracy will be defined as the percentage of images correctly identified; reaction time will represent the time taken by the participant to distinguish between the right and left foot. If participants cannot respond within 5 seconds to four or more consecutive images, this will be considered inattention, and the test will be repeated. The lateralization assessment will be performed three times for each participant, and the avera
6 secondary outcomes
Joint position sense assessment
Time frame: Baseline and after 6 weeks
Foot Pressure Assessment
Time frame: Baseline and after 6 weeks
Kinesiophobia Assessment
Time frame: Baseline and after 6 weeks
Quality of Life Assessment
Time frame: Baseline and after 6 weeks
Patient Satisfaction Assessment
Time frame: End of the intervention
Central Sensitization Assessment
Time frame: Baseline and after 6 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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program and Exercise plus graded motor imagery in people with Ankle Osteoarthritis and Foot Osteoarthritis, run by Alanya Alaaddin Keykubat University at 2 sites 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 6 inclusion and 6 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Özlem Nur Tok Yaman, PhD (+90-242-5106060, ozlem.tok@alanya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-demographic assessment form (time frame: Baseline and after 6 weeks). The study lists 6 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 30 Oct 2026.