- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417436
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Özlem Nur Tok Yaman, PhD
- Phone Number: +90-242-5106060
- Email: ozlem.tok@alanya.edu.tr
Study Locations
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Antalya, Turkey (Türkiye)
- Recruiting
- Alanya Alaaddin Keykubat University Training and Research Hospital
-
Contact:
- Özlem Nur Tok Yaman, PT, PhD Candidate
- Phone Number: +90-537-9379479
- Email: ozlem.tok@alanya.edu.tr
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Antalya
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Antalya, Antalya, Turkey (Türkiye)
- Recruiting
- Alanya Alaaddin Keykubat University Training and Research Hospital
-
Contact:
- Özlem Nur Tok Yaman, PT, PhD Candidate
- Phone Number: +90-537-9379479
- Email: ozlem.tok@alanya.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
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 |
|---|---|
|
Active Comparator: Exercise Program
|
During this intervention, participants will take part in a structured physiotherapy exercise program.
The program will be delivered under the guidance of a physiotherapist.
|
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Active Comparator: Exercise and graded motor imagery
|
During this intervention, participants will take part in the same physiotherapy exercise program combined with educational sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and after 6 weeks
|
|
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.
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Baseline and after 6 weeks
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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 |
Baseline and after 6 weeks
|
|
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
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Baseline and after 6 weeks
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|
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 .
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Baseline and after 6 weeks
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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
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Baseline and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint position sense assessment
Time Frame: Baseline and after 6 weeks
|
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
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Baseline and after 6 weeks
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Foot Pressure Assessment
Time Frame: Baseline and after 6 weeks
|
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.
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Baseline and after 6 weeks
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Kinesiophobia Assessment
Time Frame: Baseline and after 6 weeks
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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.
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Baseline and after 6 weeks
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Quality of Life Assessment
Time Frame: Baseline and after 6 weeks
|
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. |
Baseline and after 6 weeks
|
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Patient Satisfaction Assessment
Time Frame: End of the intervention
|
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.
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End of the intervention
|
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Central Sensitization Assessment
Time Frame: Baseline and after 6 weeks
|
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.
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Baseline and after 6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAU-KAEK-2025-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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