- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05138406
Graded Motor Imagery and Total Knee Arthroplasty
The Effect of Graded Motor Imagery Training on Pain, Functional Performance, Motor Imagery Skill, and Kinesiophobia After Total Knee Arthroplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burcu TALU
- Phone Number: +905317910984
- Email: fzt.burcu@hotmail.com
Study Locations
-
-
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Malatya, Turkey
- Recruiting
- Inonu Unıversity
-
Contact:
- Busra CANDIRI
- Phone Number: 05073780717
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with knee osteoarthritis and being on the waiting list to receive unilateral total knee arthroplasty
- Approved by the orthopedist for early physiotherapy treatment after total knee arthroplasty
Exclusion Criteria:
- - Individuals undergoing revision total knee arthroplasty or undergoing bilateral total knee arthroplasty,
- Contralateral knee osteoarthritis (defined by activity greater than 4/10 pain)
- Having undergone any physical therapy intervention or other surgery in the last 6 months
- Any neurological, cardiac, pulmonary or psychiatric disease (eg, uncontrolled diabetes mellitus, neoplasms, uncontrolled blood pressure, neurological conditions) before or after surgery;
- Fracture, infection in the acute postoperative phase or presence of fever
- Cognitive impairments that alter the probability of correct understanding of the motor imagery program
- Body mass index > 35 kg / m2
- Difficulties with understanding or communication
- Insufficient knowledge of Turkish to follow the study instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Graded Motor Imagery
Individuals will receive standard rehabilitation and graded motor imagery treatment.
|
The graded motor imaging program will be set to 2 weeks each component.
Participants will receive lateralization for the first 2 weeks, motor imagery for 2 weeks, and mirror therapy for 2 weeks.
At the same time, standard rehabilitation will be applied for 6 weeks.
Treatments will begin 24-48 hours after surgery.
Treatments will be applied under the control of a physiotherapist 3 days a week and as home exercise 3 days a week.
Standard rehabilitation consisting of cold therapy, stretching and strengthening exercises will be applied.
Treatment will be applied under the control of a physiotherapist 3 days a week and as home exercise 3 days a week.
|
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Active Comparator: Standard Rehabilitation Group
Standard rehabilitation will be applied.
|
Standard rehabilitation consisting of cold therapy, stretching and strengthening exercises will be applied.
Treatment will be applied under the control of a physiotherapist 3 days a week and as home exercise 3 days a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline
|
Pain at rest and during activity will be evaluated with the help of the Visual Analogue Scale (VAS).
The VAS is a 10 cm scale that rates 0 points as "no pain" and 10 points as "worst pain imaginable".
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Baseline
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Pain intensity
Time Frame: 6 weeks after surgery
|
Pain at rest and during activity will be evaluated with the help of the Visual Analogue Scale (VAS).
The VAS is a 10 cm scale that rates 0 points as "no pain" and 10 points as "worst pain imaginable".
|
6 weeks after surgery
|
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Pain intensity
Time Frame: 6 months after surgery
|
Pain at rest and during activity will be evaluated with the help of the Visual Analogue Scale (VAS).
The VAS is a 10 cm scale that rates 0 points as "no pain" and 10 points as "worst pain imaginable".
|
6 months after surgery
|
|
WOMAC
Time Frame: Baseline
|
Functional status will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
It consists of three subgroups as pain (5 items), stiffness (2 items) and physical function (17 items) and a total of 24 items.
Each item has an evaluation score of 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
|
Baseline
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WOMAC
Time Frame: 6 weeks after surgery
|
Functional status will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
It consists of three subgroups as pain (5 items), stiffness (2 items) and physical function (17 items) and a total of 24 items.
Each item has an evaluation score of 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
|
6 weeks after surgery
|
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WOMAC
Time Frame: 6 months after surgery
|
Functional status will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
It consists of three subgroups as pain (5 items), stiffness (2 items) and physical function (17 items) and a total of 24 items.
Each item has an evaluation score of 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
|
6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain threshold
Time Frame: Baseline
|
A pressure algometer (digital algometer) will be used. It will be evaluated at four test sites at the knee (medial and lateral edge of the patella, lateral and medial femoral condyles) and one distal painless zone at the wrist extensors (5 cm distal to the lateral epicondyle). It will be pressed with increasing pressure and the individual will be asked to say "yes" as soon as the participant feels pain or discomfort. Three attempts will be made at each point with a 30-second rest and the averages recorded. |
Baseline
|
|
Pressure pain threshold
Time Frame: 6 weeks after surgery
|
A pressure algometer (digital algometer) will be used. It will be evaluated at four test sites at the knee (medial and lateral edge of the patella, lateral and medial femoral condyles) and one distal painless zone at the wrist extensors (5 cm distal to the lateral epicondyle). It will be pressed with increasing pressure and the individual will be asked to say "yes" as soon as the participant feels pain or discomfort. Three attempts will be made at each point with a 30-second rest and the averages recorded. |
6 weeks after surgery
|
|
Pressure pain threshold
Time Frame: 6 months after surgery
|
A pressure algometer (digital algometer) will be used. It will be evaluated at four test sites at the knee (medial and lateral edge of the patella, lateral and medial femoral condyles) and one distal painless zone at the wrist extensors (5 cm distal to the lateral epicondyle). It will be pressed with increasing pressure and the individual will be asked to say "yes" as soon as the participant feels pain or discomfort. Three attempts will be made at each point with a 30-second rest and the averages recorded. |
6 months after surgery
|
|
Central sensitization
Time Frame: Baseline
|
It will be evaluated with the Central Sensitization Inventory.
It consists of 2 parts, part A, which evaluates the symptoms thought to be associated with central sensitization syndromes, and part B, which quickly questions whether the patient has received a specific diagnosis before.
In part A, there are 25 items that question the frequency of symptoms seen in central sensitization syndromes and are scored between 0-100 points.
Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" (3 points) if often It is recorded as "always" (4 points).
As the patient's central sensitization inventory score increases, it is thought that he has more symptoms related to central sensitization.
In part B, it is questioned whether the patient has ever been diagnosed with any of the diseases included in the central sensitization syndromes by any physician.
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Baseline
|
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Central sensitization
Time Frame: 6 weeks after surgery
|
It will be evaluated with the Central Sensitization Inventory.
It consists of 2 parts, part A, which evaluates the symptoms thought to be associated with central sensitization syndromes, and part B, which quickly questions whether the patient has received a specific diagnosis before.
In part A, there are 25 items that question the frequency of symptoms seen in central sensitization syndromes and are scored between 0-100 points.
Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" (3 points) if often It is recorded as "always" (4 points).
As the patient's central sensitization inventory score increases, it is thought that he has more symptoms related to central sensitization.
In part B, it is questioned whether the patient has ever been diagnosed with any of the diseases included in the central sensitization syndromes by any physician.
|
6 weeks after surgery
|
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Central sensitization
Time Frame: 6 months after surgery
|
It will be evaluated with the Central Sensitization Inventory.
It consists of 2 parts, part A, which evaluates the symptoms thought to be associated with central sensitization syndromes, and part B, which quickly questions whether the patient has received a specific diagnosis before.
In part A, there are 25 items that question the frequency of symptoms seen in central sensitization syndromes and are scored between 0-100 points.
Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" (3 points) if often It is recorded as "always" (4 points).
As the patient's central sensitization inventory score increases, it is thought that he has more symptoms related to central sensitization.
In part B, it is questioned whether the patient has ever been diagnosed with any of the diseases included in the central sensitization syndromes by any physician.
|
6 months after surgery
|
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Joint Range of Motion
Time Frame: Baseline
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Active knee flexion and extension angle will be evaluated.
|
Baseline
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Joint Range of Motion
Time Frame: 6 weeks after surgery
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Active knee flexion and extension angle will be evaluated.
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6 weeks after surgery
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Joint Range of Motion
Time Frame: 6 months after surgery
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Active knee flexion and extension angle will be evaluated.
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6 months after surgery
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Quadriceps muscle strength
Time Frame: Baseline
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It will be measured during maximum voluntary isometric contraction using a hand-held muscle tester.
After a warm-up test attempt, participants will be asked to extend their knees with maximum force against the device for five seconds.
Two trials separated by a rest period of 120 seconds will be performed and averaged.
|
Baseline
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Quadriceps muscle strength
Time Frame: 6 weeks after surgery
|
It will be measured during maximum voluntary isometric contraction using a hand-held muscle tester.
After a warm-up test attempt, participants will be asked to extend their knees with maximum force against the device for five seconds.
Two trials separated by a rest period of 120 seconds will be performed and averaged.
|
6 weeks after surgery
|
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Quadriceps muscle strength
Time Frame: 6 months after surgery
|
It will be measured during maximum voluntary isometric contraction using a hand-held muscle tester.
After a warm-up test attempt, participants will be asked to extend their knees with maximum force against the device for five seconds.
Two trials separated by a rest period of 120 seconds will be performed and averaged.
|
6 months after surgery
|
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Kinesiophobia
Time Frame: Baseline
|
The Tampa Kinesiophobia Scale will be used.
A 4-point Likert score (1=I totally disagree, 2=Agree, 3=Disagree, 4=Totally agree) is used for each question in the scale.
As a result of the survey, the person gets a total score between 17-68.
A high score on the scale indicates a high level of kinesiophobia.
|
Baseline
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Kinesiophobia
Time Frame: 6 weeks after surgery
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The Tampa Kinesiophobia Scale will be used.
A 4-point Likert score (1=I totally disagree, 2=Agree, 3=Disagree, 4=Totally agree) is used for each question in the scale.
As a result of the survey, the person gets a total score between 17-68.
A high score on the scale indicates a high level of kinesiophobia.
|
6 weeks after surgery
|
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Kinesiophobia
Time Frame: 6 months after surgery
|
The Tampa Kinesiophobia Scale will be used.
A 4-point Likert score (1=I totally disagree, 2=Agree, 3=Disagree, 4=Totally agree) is used for each question in the scale.
As a result of the survey, the person gets a total score between 17-68.
A high score on the scale indicates a high level of kinesiophobia.
|
6 months after surgery
|
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Functional mobility
Time Frame: Baseline
|
The Timed Up and Go test will be used.
While the patient is sitting in a chair; will be asked to get up from the chair, walk 3 meters as fast as possible, turn around and sit back in the chair.
The time elapsed while the patient performs the test will be recorded.
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Baseline
|
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Functional mobility
Time Frame: 6 weeks after surgery
|
The Timed Up and Go test will be used.
While the patient is sitting in a chair; will be asked to get up from the chair, walk 3 meters as fast as possible, turn around and sit back in the chair.
The time elapsed while the patient performs the test will be recorded.
|
6 weeks after surgery
|
|
Functional mobility
Time Frame: 6 months after surgery
|
The Timed Up and Go test will be used.
While the patient is sitting in a chair; will be asked to get up from the chair, walk 3 meters as fast as possible, turn around and sit back in the chair.
The time elapsed while the patient performs the test will be recorded.
|
6 months after surgery
|
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Mental chronometry delta time
Time Frame: Baseline
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Timed Get Up and Go test will be used.
It compares the time between the actual movement time and the imagined similar task time.
At the end of the tests, mental chronometer measurements are calculated in terms of delta time with the formula '(real movement-imagined movement)/[(real movement+imagined movement)/2]x100'.
|
Baseline
|
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Mental chronometry delta time
Time Frame: 6 weeks after surgery
|
Timed Get Up and Go test will be used.
It compares the time between the actual movement time and the imagined similar task time.
At the end of the tests, mental chronometer measurements are calculated in terms of delta time with the formula '(real movement-imagined movement)/[(real movement+imagined movement)/2]x100'.
|
6 weeks after surgery
|
|
Mental chronometry delta time
Time Frame: 6 months after surgery
|
Timed Get Up and Go test will be used.
It compares the time between the actual movement time and the imagined similar task time.
At the end of the tests, mental chronometer measurements are calculated in terms of delta time with the formula '(real movement-imagined movement)/[(real movement+imagined movement)/2]x100'.
|
6 months after surgery
|
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Laterality task
Time Frame: Baseline
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Right-left discrimination will be evaluated using the Recognise™ application.
The percentage of correct answers and reaction time will be recorded.
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Baseline
|
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Laterality task
Time Frame: 6 weeks after surgery
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Right-left discrimination will be evaluated using the Recognise™ application.
The percentage of correct answers and reaction time will be recorded.
|
6 weeks after surgery
|
|
Laterality task
Time Frame: 6 months after surgery
|
Right-left discrimination will be evaluated using the Recognise™ application.
The percentage of correct answers and reaction time will be recorded.
|
6 months after surgery
|
|
Movement Imagery Questionnaire-3 (MIQ-3)
Time Frame: Baseline
|
It is a questionnaire that evaluates the imagery of four movements consisting of knee bending, jumping, arm movement and bending.
It consists of three subscales and a total of 12 items evaluating external visual imagery, internal visual imagery, and kinesthetic imagery.
Before starting the questionnaire, participants are given definitions of external visual imagery, internal visual imagery, and kinesthetic imagery.
Before scoring each movement, the person is asked to perform the movement, then the movement is visualized three times.
It is scored on a scale from 1 to 7. 1 point means "very difficult to see/feel", while 7 points means "very easy to see/feel".
|
Baseline
|
|
Movement Imagery Questionnaire-3 (MIQ-3)
Time Frame: 6 weeks after surgery
|
It is a questionnaire that evaluates the imagery of four movements consisting of knee bending, jumping, arm movement and bending.
It consists of three subscales and a total of 12 items evaluating external visual imagery, internal visual imagery, and kinesthetic imagery.
Before starting the questionnaire, participants are given definitions of external visual imagery, internal visual imagery, and kinesthetic imagery.
Before scoring each movement, the person is asked to perform the movement, then the movement is visualized three times.
It is scored on a scale from 1 to 7. 1 point means "very difficult to see/feel", while 7 points means "very easy to see/feel".
|
6 weeks after surgery
|
|
Movement Imagery Questionnaire-3 (MIQ-3)
Time Frame: 6 months after surgery
|
It is a questionnaire that evaluates the imagery of four movements consisting of knee bending, jumping, arm movement and bending.
It consists of three subscales and a total of 12 items evaluating external visual imagery, internal visual imagery, and kinesthetic imagery.
Before starting the questionnaire, participants are given definitions of external visual imagery, internal visual imagery, and kinesthetic imagery.
Before scoring each movement, the person is asked to perform the movement, then the movement is visualized three times.
It is scored on a scale from 1 to 7. 1 point means "very difficult to see/feel", while 7 points means "very easy to see/feel".
|
6 months after surgery
|
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Pain Catastrophizing Scale
Time Frame: Baseline
|
There are 13 states on the scale that describe different feelings and thoughts that may be associated with pain.
Participants in each of these situations; 0: None, 1: Mildly, 2: Moderately, 3: Mostly, 4: Always.
The total score is between 0-52; It is obtained by summing all 13 items.
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Baseline
|
|
Pain Catastrophizing Scale
Time Frame: 6 weeks after surgery
|
There are 13 states on the scale that describe different feelings and thoughts that may be associated with pain.
Participants in each of these situations; 0: None, 1: Mildly, 2: Moderately, 3: Mostly, 4: Always.
The total score is between 0-52; It is obtained by summing all 13 items.
|
6 weeks after surgery
|
|
Pain Catastrophizing Scale
Time Frame: 6 months after surgery
|
There are 13 states on the scale that describe different feelings and thoughts that may be associated with pain.
Participants in each of these situations; 0: None, 1: Mildly, 2: Moderately, 3: Mostly, 4: Always.
The total score is between 0-52; It is obtained by summing all 13 items.
|
6 months after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- La Touche R, Grande-Alonso M, Cuenca-Martinez F, Gonzalez-Ferrero L, Suso-Marti L, Paris-Alemany A. Diminished Kinesthetic and Visual Motor Imagery Ability in Adults With Chronic Low Back Pain. PM R. 2019 Mar;11(3):227-235. doi: 10.1016/j.pmrj.2018.05.025. Epub 2019 Jan 15.
- Dilek B, Ayhan C, Yagci G, Yakut Y. Effectiveness of the graded motor imagery to improve hand function in patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jan-Mar;31(1):2-9.e1. doi: 10.1016/j.jht.2017.09.004. Epub 2017 Nov 6.
- Gurudut P, Jaiswal R. Comparative Effect of Graded Motor Imagery and Progressive Muscle Relaxation on Mobility and Function in Patients with Knee Osteoarthritis: A Pilot Study. Altern Ther Health Med. 2022 Mar;28(3):42-47.
- Lee HG, An J, Lee BH. The Effect of Progressive Dynamic Balance Training on Physical Function, The Ability to Balance and Quality of Life Among Elderly Women Who Underwent a Total Knee Arthroplasty: A Double-Blind Randomized Control Trial. Int J Environ Res Public Health. 2021 Mar 3;18(5):2513. doi: 10.3390/ijerph18052513.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- 2021/173
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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