Total Knee ArthroplastyNCT05138406
Graded Motor Imagery and Total Knee Arthroplasty
A study testing Graded Motor Imagery and Standard Rehabilitation in people with Total Knee Arthroplasty, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the long-term effectiveness of the early application of graded motor imagery therapy on pain parameters, functional performance, motor imagery skill, and kinesiophobia in individuals who underwent total knee arthroplasty surgery after knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Graded Motor Imagery and Standard Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 9Show fewer
- Body mass index > 35 kg / m2
- Difficulties with understanding or communication
- Insufficient knowledge of Turkish to follow the study instructions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu Unıversity
Malatya
Busra CANDIRI, 05073780717
About this study
Official title: The Effect of Graded Motor Imagery Training on Pain, Functional Performance, Motor Imagery Skill, and Kinesiophobia After Total Knee Arthroplasty.
This study was planned to investigate the long-term effectiveness of the early application of graded motor imagery therapy on pain parameters, functional performance, motor imagery skill, and kinesiophobia in individuals who underwent total knee arthroplasty surgery after knee osteoarthritis.
Read the detailed description
Participants aged 45-80 who are scheduled for total knee arthroplasty surgery after knee osteoarthritis will be included. Participants will be selected from the relevant population using a nonprobability random sampling method. Participants who agree to participate in the study and meet the inclusion criteria will be assigned to one of the groups (conventional rehabilitation-only or conventional rehabilitation with graded motor imagery) using the closed envelope method. Evaluations will be made one day before surgery, 6 weeks and 6 months after surgery for each group. Pain Visual Analog Scale; pressure pain threshold algometer; central sensitization Central Sensitization Inventory; the joint range of motion goniometer; muscle strength handheld dynamometer; kinesiophobia Tampa Kinesiophobia Scale; functional mobility and mental stopwatch Timed get up and go test; choice task Recognise™ application; motor imagery skill Movement Imagery Questionnaire-3; functional assessment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); The catastrophic degree of pain is planned to be evaluated with the Pain Catastrophizing Scale.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Graded Motor Imagery, Standard Rehabilitation
- Keywords
- Graded Motor Imagery, Pain, Rehabilitation, Total knee arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor ImageryOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor Imagery | Experimental | Individuals will receive standard rehabilitation and graded motor imagery treatment. Receives: Other: Graded Motor Imagery; Other: Standard Rehabilitation |
| Standard Rehabilitation Group | Active comparator | Standard rehabilitation will be applied. Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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".
Measured: Baseline
Pain intensity
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".
Measured: 6 weeks after surgery
Pain intensity
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".
Measured: 6 months after surgery
WOMAC
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.
Measured: Baseline
WOMAC
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.
Measured: 6 weeks after surgery
WOMAC
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.
Measured: 6 months after surgery
Secondary outcomes (30)
Pressure pain threshold
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.
Measured: Baseline
Pressure pain threshold
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.
Measured: 6 weeks after surgery
Pressure pain threshold
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.
Measured: 6 months after surgery
Central sensitization
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.
Measured: Baseline
Central sensitization
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.
Measured: 6 weeks after surgery
Central sensitization
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.
Measured: 6 months after surgery
Joint Range of Motion
Active knee flexion and extension angle will be evaluated.
Measured: Baseline
Joint Range of Motion
Active knee flexion and extension angle will be evaluated.
Measured: 6 weeks after surgery
Joint Range of Motion
Active knee flexion and extension angle will be evaluated.
Measured: 6 months after surgery
Quadriceps muscle strength
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.
Measured: Baseline
Quadriceps muscle strength
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.
Measured: 6 weeks after surgery
Quadriceps muscle strength
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.
Measured: 6 months after surgery
Kinesiophobia
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.
Measured: Baseline
Kinesiophobia
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.
Measured: 6 weeks after surgery
Kinesiophobia
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.
Measured: 6 months after surgery
Functional mobility
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.
Measured: Baseline
Functional mobility
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.
Measured: 6 weeks after surgery
Functional mobility
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.
Measured: 6 months after surgery
Mental chronometry delta time
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'.
Measured: Baseline
Mental chronometry delta time
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'.
Measured: 6 weeks after surgery
Mental chronometry delta time
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'.
Measured: 6 months after surgery
Laterality task
Right-left discrimination will be evaluated using the Recognise™ application. The percentage of correct answers and reaction time will be recorded.
Measured: Baseline
Laterality task
Right-left discrimination will be evaluated using the Recognise™ application. The percentage of correct answers and reaction time will be recorded.
Measured: 6 weeks after surgery
Laterality task
Right-left discrimination will be evaluated using the Recognise™ application. The percentage of correct answers and reaction time will be recorded.
Measured: 6 months after surgery
Movement Imagery Questionnaire-3 (MIQ-3)
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".
Measured: Baseline
Movement Imagery Questionnaire-3 (MIQ-3)
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".
Measured: 6 weeks after surgery
Movement Imagery Questionnaire-3 (MIQ-3)
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".
Measured: 6 months after surgery
Pain Catastrophizing Scale
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.
Measured: Baseline
Pain Catastrophizing Scale
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.
Measured: 6 weeks after surgery
Pain Catastrophizing Scale
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start28 Feb 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu TALU, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138406
- Sponsor's protocol ID
- 2021/173
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29908933Dilek 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.
PubMed 29122370Gurudut 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.
PubMed 33128533Lee 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.
PubMed 33802559
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Graded Motor Imagery Training on Pain, Functional Performance, Motor Imagery Skill, and Kinesiophobia After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT05138406
- Acronym / sponsor ID
- 2021/173
- Conditions
- Total Knee Arthroplasty
- Keywords
- Graded Motor Imagery, Pain, Rehabilitation, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 1 Dec 2021 (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.
This study was planned to investigate the long-term effectiveness of the early application of graded motor imagery therapy on pain parameters, functional performance, motor imagery skill, and kinesiophobia in individuals who underwent total knee arthroplasty surgery after knee osteoarthritis.
Detailed description
Participants aged 45-80 who are scheduled for total knee arthroplasty surgery after knee osteoarthritis will be included. Participants will be selected from the relevant population using a nonprobability random sampling method. Participants who agree to participate in the study and meet the inclusion criteria will be assigned to one of the groups (conventional rehabilitation-only or conventional rehabilitation with graded motor imagery) using the closed envelope method. Evaluations will be made one day before surgery, 6 weeks and 6 months after surgery for each group. Pain Visual Analog Scale; pressure pain threshold algometer; central sensitization Central Sensitization Inventory; the joint range of motion goniometer; muscle strength handheld dynamometer; kinesiophobia Tampa Kinesiophobia Scale; functional mobility and mental stopwatch Timed get up and go test; choice task Recognise™ application; motor imagery skill Movement Imagery Questionnaire-3; functional assessment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); The catastrophic degree of pain is planned to be evaluated with the Pain Catastrophizing Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery | Experimental | Other: Graded Motor Imagery, Other: Standard RehabilitationIndividuals will receive standard rehabilitation and graded motor imagery treatment. |
| Standard Rehabilitation Group | Active comparator | Other: Standard RehabilitationStandard rehabilitation will be applied. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- - 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
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 |
|---|---|---|
| Graded Motor ImageryThe 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. | Other | Graded Motor Imagery |
| Standard RehabilitationStandard 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. | Other | Graded Motor Imagery, Standard Rehabilitation Group |
Primary outcome
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".
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".
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".
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.
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.
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.
30 secondary outcomes
Pressure pain threshold
Time frame: Baseline
Pressure pain threshold
Time frame: 6 weeks after surgery
Pressure pain threshold
Time frame: 6 months after surgery
Central sensitization
Time frame: Baseline
Central sensitization
Time frame: 6 weeks after surgery
Central sensitization
Time frame: 6 months after surgery
Joint Range of Motion
Time frame: Baseline
Joint Range of Motion
Time frame: 6 weeks after surgery
Joint Range of Motion
Time frame: 6 months after surgery
Quadriceps muscle strength
Time frame: Baseline
Quadriceps muscle strength
Time frame: 6 weeks after surgery
Quadriceps muscle strength
Time frame: 6 months after surgery
Kinesiophobia
Time frame: Baseline
Kinesiophobia
Time frame: 6 weeks after surgery
Kinesiophobia
Time frame: 6 months after surgery
Functional mobility
Time frame: Baseline
Functional mobility
Time frame: 6 weeks after surgery
Functional mobility
Time frame: 6 months after surgery
Mental chronometry delta time
Time frame: Baseline
Mental chronometry delta time
Time frame: 6 weeks after surgery
Mental chronometry delta time
Time frame: 6 months after surgery
Laterality task
Time frame: Baseline
Laterality task
Time frame: 6 weeks after surgery
Laterality task
Time frame: 6 months after surgery
Movement Imagery Questionnaire-3 (MIQ-3)
Time frame: Baseline
Movement Imagery Questionnaire-3 (MIQ-3)
Time frame: 6 weeks after surgery
Movement Imagery Questionnaire-3 (MIQ-3)
Time frame: 6 months after surgery
Pain Catastrophizing Scale
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: 6 weeks after surgery
Pain Catastrophizing Scale
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 29908933La 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.
- Background: PubMed 29122370Dilek 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.
- Background: PubMed 33128533Gurudut 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.
- Background: PubMed 33802559Lee 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.
- 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. This study is not recruiting at the moment.
Burcu TALU principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery and Standard Rehabilitation in people with Total Knee Arthroplasty, run by Inonu University at 1 site 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Busra CANDIRI (+905073780717, candiri_17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT05138406, which also lists 4 linked publications.
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 14 Nov 2022.