- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327190
Motor Imagery and Action Observation Training in Total Knee Arthroplasty
Effects of Motor Imagery and Action Observation Training on Pain, Functionality, Balance and Fear of Movement in Total Knee Arthroplasty: A Randomized Controlled Trial.
This single-center randomized controlled trial aims to evaluate the effects of motor imagery and action observation training on pain, functionality, balance, and fear of movement in patients after total knee arthroplasty (TKA). The study will be conducted at Simav Doç. Dr. İsmail Karakuyu State Hospital Orthopedics Department with a minimum of 40 participants meeting the inclusion criteria. Participants will be randomly assigned to one of three groups: (1) standard physiotherapy, (2) standard physiotherapy plus motor imagery training, or (3) standard physiotherapy plus action observation training.
All interventions will last six weeks. Standard physiotherapy will include ankle pumping, active-assisted hip and knee flexion, isometric and stretching exercises, cryotherapy, gait, and stair training. The motor imagery group will perform guided imagery sessions using audio recordings describing the physiotherapy exercises and daily activities. The action observation group will observe exercise videos corresponding to the physiotherapy program.
The primary outcomes will include pain, functional level, balance, and kinesiophobia. The study aims to determine whether the addition of mental simulation techniques to standard physiotherapy can enhance postoperative recovery and improve functional outcomes in patients undergoing total knee arthroplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kütahya
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Kütahya, Kütahya, Turkey (Türkiye), 43000
- Kutahya Health Sciences University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those diagnosed with degenerative gonarthrosis and who have experienced unilateral TDA
- Those over 25 years of age
- Those who have obtained a passing score on the Mini Mental Test (>24)
Exclusion Criteria:
- Body mass index of 40 kg/m2 or higher,
- Revision/bilateral TDA,
- Self-reported sensory, cognitive, neurological or motor impairment that would limit participation in the study; history of psychosis; or concomitant diseases that would negatively affect recovery, such as hemiparesis, peripheral neuropathy, lymphedema or lower extremity amputation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group (Traditional Physiotherapy)
Standard physiotherapy exercise routines will include: ankle pumping exercises, passive/active/active assisted hip flexion (straight leg raise), abduction/adduction, passive/active/active assisted hip-knee flexion (starting from 30°-40°), isometric exercises (quadriceps, adductor, gluteal muscles, hamstrings), cryotherapy (3 times a day), and stretching exercises (hamstring, gastro-soleus), along with walker assistance for standing, walking training, and stair training.
In addition, participants in this group will be given recordings containing nature sounds and nature videos to listen to and watch after their exercises.
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Patients will be given a standard physiotherapy program consisting of 0-2 weeks and 2-6 weeks, with the first week mainly featuring isometric exercises, stretching exercises, and ankle pumping exercises, and the second-6 weeks transitioning to strengthening exercises.
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Experimental: Motor imagery group
In motor imagery training, participants will visualize standard physiotherapy tasks using audio recordings presented as metaphors.
Participants will be asked to fully focus on visualizing the movements in a quiet environment.
They will also be asked to imagine different activities from daily life, progressing from simple to more challenging.
Patients will undergo imagery training with audio recordings of standard physiotherapy exercises for six weeks.
The training content will parallel the standard physiotherapy program.
Participants in the motor imagery training group will be provided with audio explanations (mp3 files) of the motor imagery session instructions to continue at home.
Patients in this group will also watch videos containing nature visuals.
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In addition to standard visual therapy, patients will be sent audio recordings that allow them to visualize movement; they will also be sent nature videos.
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Experimental: Action observation group
In the action observation group, participants will observe movements by watching videos of standard physiotherapy tasks in addition to standard physiotherapy.
The training content will progress in parallel with the standard physiotherapy program.
The training content will be prepared by clearly recording frontal or lateral views of all exercises included in the standard physiotherapy curriculum (0-2 week, 2-6 week exercises).
Patients in this group will also listen to an audio recording containing relaxing music.
|
In this group, in addition to standard physiotherapy, participants will be given videos showing visuals of the movements and will also be sent audio recordings containing nature sounds during the session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength Assessment:
Time Frame: a day before the operation
|
Muscle strength will be measured using a handheld dynamometer (Lafayette Instrument®) located in the physiotherapy unit, with the knee in a 90° flexion position.
The device will be placed on the front surface above the malleoli of the ankle.
A maximum isometric contraction in the extension direction will be requested against the device for 5 seconds.
Three repetitions of the movement will be performed, and the average will be taken.
A 30-second rest break will be given between each contraction.
Measurements will be recorded in kilograms.
The muscle strength measuring instrument will be obtained from the physiotherapy unit.
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a day before the operation
|
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Muscle Strength Assessment:
Time Frame: after 2 weeks of operation
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Muscle strength will be measured using a handheld dynamometer (Lafayette Instrument®) located in the physiotherapy unit, with the knee in a 90° flexion position.
The device will be placed on the front surface above the malleoli of the ankle.
A maximum isometric contraction in the extension direction will be requested against the device for 5 seconds.
Three repetitions of the movement will be performed, and the average will be taken.
A 30-second rest break will be given between each contraction.
Measurements will be recorded in kilograms.
The muscle strength measuring instrument will be obtained from the physiotherapy unit.
|
after 2 weeks of operation
|
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Muscle Strength Assessment:
Time Frame: after 6 weeks of operation
|
Muscle strength will be measured using a handheld dynamometer (Lafayette Instrument®) located in the physiotherapy unit, with the knee in a 90° flexion position.
The device will be placed on the front surface above the malleoli of the ankle.
A maximum isometric contraction in the extension direction will be requested against the device for 5 seconds.
Three repetitions of the movement will be performed, and the average will be taken.
A 30-second rest break will be given between each contraction.
Measurements will be recorded in kilograms.
The muscle strength measuring instrument will be obtained from the physiotherapy unit.
|
after 6 weeks of operation
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Functional Assessment
Time Frame: a day before the operation
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The WOMAC will be used for functional assessment.
The WOMAC consists of sub-sections for pain, stiffness, and physical function.
Higher scores indicate greater pain, stiffness, and worse physical function.
|
a day before the operation
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Functional Assessment
Time Frame: after 2 weeks of operation
|
The WOMAC will be used for functional assessment.
The WOMAC consists of sub-sections for pain, stiffness, and physical function.
Higher scores indicate greater pain, stiffness, and worse physical function.
|
after 2 weeks of operation
|
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Functional Assessment
Time Frame: after 6 weeks of operation
|
The WOMAC will be used for functional assessment.
The WOMAC consists of sub-sections for pain, stiffness, and physical function.
Higher scores indicate greater pain, stiffness, and worse physical function.
|
after 6 weeks of operation
|
|
Timed Get Up and Walk (TUG) Test
Time Frame: a day before the operation
|
This test will be used to assess physical performance.
For the test, participants will be asked to get up from a seated position without holding onto the chair's arms, walk 3 meters, return to the chair, and walk back to sit down.
The elapsed time will be measured and recorded using a stopwatch.
The test will be repeated 3 times, and the average will be taken.
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a day before the operation
|
|
Timed Get Up and Walk (TUG) Test
Time Frame: after 2 weeks of operation
|
This test will be used to assess physical performance.
For the test, participants will be asked to get up from a seated position without holding onto the chair's arms, walk 3 meters, return to the chair, and walk back to sit down.
The elapsed time will be measured and recorded using a stopwatch.
The test will be repeated 3 times, and the average will be taken.
|
after 2 weeks of operation
|
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Timed Get Up and Walk (TUG) Test
Time Frame: after 6 weeks of operation
|
This test will be used to assess physical performance.
For the test, participants will be asked to get up from a seated position without holding onto the chair's arms, walk 3 meters, return to the chair, and walk back to sit down.
The elapsed time will be measured and recorded using a stopwatch.
The test will be repeated 3 times, and the average will be taken.
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after 6 weeks of operation
|
|
ROM Assessment
Time Frame: a day before the operation
|
A standard goniometer will be used to assess active ROM.
For knee flexion ROM, the fixed arm of the goniometer will be placed parallel to the long axis of the femur.
The movable arm will be placed parallel to the long axis of the fibula.
The participant will be asked to flex their knee without breaking contact between their foot and the bed.
Extension angle will be measured using the same procedure after the heel is placed approximately 15 cm high and the participant is asked to perform active knee extension.
Flexion and extension measurements will be repeated 3 times, and the averages will be recorded.
|
a day before the operation
|
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ROM Assessment
Time Frame: after 2 weeks of operation
|
A standard goniometer will be used to assess active ROM.
For knee flexion ROM, the fixed arm of the goniometer will be placed parallel to the long axis of the femur.
The movable arm will be placed parallel to the long axis of the fibula.
The participant will be asked to flex their knee without breaking contact between their foot and the bed.
Extension angle will be measured using the same procedure after the heel is placed approximately 15 cm high and the participant is asked to perform active knee extension.
Flexion and extension measurements will be repeated 3 times, and the averages will be recorded.
|
after 2 weeks of operation
|
|
ROM Assessment
Time Frame: after 6 weeks of operation
|
A standard goniometer will be used to assess active ROM.
For knee flexion ROM, the fixed arm of the goniometer will be placed parallel to the long axis of the femur.
The movable arm will be placed parallel to the long axis of the fibula.
The participant will be asked to flex their knee without breaking contact between their foot and the bed.
Extension angle will be measured using the same procedure after the heel is placed approximately 15 cm high and the participant is asked to perform active knee extension.
Flexion and extension measurements will be repeated 3 times, and the averages will be recorded.
|
after 6 weeks of operation
|
|
Assessment of Kinesiophobia
Time Frame: a day before the operation
|
he Tampa Kinesiophobia Scale will be used.
The Turkish validity and reliability of the TKÖ, a 17-question scale designed to measure fear of movement, was established by Tunca Yılmaz et al. in 2011.
A 4-point Likert scale is used (Strongly disagree: 1, Disagree: 2, Agree: 3, Strongly agree: 4).
Questions 4, 8, 12, and 16 are reverse Likert scales; the total scale score is calculated as 33.
Individuals will receive a total score between 17 and 68.
The higher the score on the scale, the higher the fear of movement.
|
a day before the operation
|
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Assessment of Kinesiophobia
Time Frame: after 2 weeks of operation
|
he Tampa Kinesiophobia Scale will be used.
The Turkish validity and reliability of the TKÖ, a 17-question scale designed to measure fear of movement, was established by Tunca Yılmaz et al. in 2011.
A 4-point Likert scale is used (Strongly disagree: 1, Disagree: 2, Agree: 3, Strongly agree: 4).
Questions 4, 8, 12, and 16 are reverse Likert scales; the total scale score is calculated as 33.
Individuals will receive a total score between 17 and 68.
The higher the score on the scale, the higher the fear of movement.
|
after 2 weeks of operation
|
|
Assessment of Kinesiophobia
Time Frame: after 6 weeks of operation
|
he Tampa Kinesiophobia Scale will be used.
The Turkish validity and reliability of the TKÖ, a 17-question scale designed to measure fear of movement, was established by Tunca Yılmaz et al. in 2011.
A 4-point Likert scale is used (Strongly disagree: 1, Disagree: 2, Agree: 3, Strongly agree: 4).
Questions 4, 8, 12, and 16 are reverse Likert scales; the total scale score is calculated as 33.
Individuals will receive a total score between 17 and 68.
The higher the score on the scale, the higher the fear of movement.
|
after 6 weeks of operation
|
|
The Standardized Mini Mental Test (SMMT)
Time Frame: a day before the operation
|
It is a short, efficient, and standardized method that can be preferred for determining an individual's cognitive level.
It is divided into five sections: orientation, recording memory, attention and calculation, recall, and language.
There are eleven items for individuals to answer.
It is evaluated out of a total of 30 points.
The Turkish validity and reliability study was conducted by Güngen et al.
In the validity and reliability study, the threshold value was determined as 24 points.
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a day before the operation
|
|
The Standardized Mini Mental Test (SMMT)
Time Frame: after 2 weeks of operation
|
It is a short, efficient, and standardized method that can be preferred for determining an individual's cognitive level.
It is divided into five sections: orientation, recording memory, attention and calculation, recall, and language.
There are eleven items for individuals to answer.
It is evaluated out of a total of 30 points.
The Turkish validity and reliability study was conducted by Güngen et al.
In the validity and reliability study, the threshold value was determined as 24 points.
|
after 2 weeks of operation
|
|
The Standardized Mini Mental Test (SMMT)
Time Frame: after 6 weeks of operation
|
It is a short, efficient, and standardized method that can be preferred for determining an individual's cognitive level.
It is divided into five sections: orientation, recording memory, attention and calculation, recall, and language.
There are eleven items for individuals to answer.
It is evaluated out of a total of 30 points.
The Turkish validity and reliability study was conducted by Güngen et al.
In the validity and reliability study, the threshold value was determined as 24 points.
|
after 6 weeks of operation
|
|
Pain Assessment
Time Frame: a day before the operation
|
Pain intensity will be measured using a Visual Analog Scale.
It is a 100 mm scale.
The patient marks a point on the line between 'no pain' and 'unbearable pain' according to their level of pain during free walking.
A higher score means more pain.
|
a day before the operation
|
|
Pain Assessment
Time Frame: after 2 weeks of operation
|
Pain intensity will be measured using a Visual Analog Scale.
It is a 100 mm scale.
The patient marks a point on the line between 'no pain' and 'unbearable pain' according to their level of pain during free walking.
A higher score means more pain.
|
after 2 weeks of operation
|
|
Pain Assessment
Time Frame: after 6 weeks of operation
|
Pain intensity will be measured using a Visual Analog Scale.
It is a 100 mm scale.
The patient marks a point on the line between 'no pain' and 'unbearable pain' according to their level of pain during free walking.
A higher score means more pain.
|
after 6 weeks of operation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- KSBU-TDA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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