Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis

NCT07417436 | Recruiting

• 1 other identifier: PAU-KAEK-2025-15
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Ankle Osteoarthritis; Foot Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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

  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

  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 .

  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

  Baseline and after 6 weeks

Secondary Outcomes (6)

• Joint position sense assessment

  Baseline and after 6 weeks

• Foot Pressure Assessment

  Baseline and after 6 weeks

• Kinesiophobia Assessment

  Baseline and after 6 weeks

• Quality of Life Assessment

  Baseline and after 6 weeks

• Patient Satisfaction Assessment

  End of the intervention

Study Arms (2)

Exercise Program

ACTIVE COMPARATOR

Behavioral: Exercise Program

Exercise and graded motor imagery

ACTIVE COMPARATOR

Behavioral: Exercise plus graded motor imagery

Interventions

Exercise Program BEHAVIORAL

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 Program

Exercise plus graded motor imagery BEHAVIORAL

During this intervention, participants will take part in the same physiotherapy exercise program combined with educational sessions.

Exercise and graded motor imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (2)

Alanya Alaaddin Keykubat University Training and Research Hospital

Antalya, Antalya, Turkey (Türkiye)

RECRUITING

Alanya Alaaddin Keykubat University Training and Research Hospital

Antalya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Resistance Training; Exercise

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Özlem Nur Tok Yaman, PhD

CONTACT

+90-242-5106060; ozlem.tok@alanya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: August 28, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)