Graded Motor Imagery and Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

The Effect of Graded Motor Imagery Training on Pain, Functional Performance, Motor Imagery Skill, and Kinesiophobia After Total Knee Arthroplasty.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138406
• Other study ID #: 2021/173
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2022
• Source: Inonu University
• Contact: Busra CANDIRI
• Phone: +905073780717
• Email: candiri_17[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Other:
• Graded Motor Imagery
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
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.

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

La Touche R, Grande-Alonso M, Cuenca-Martínez F, Gónzález-Ferrero L, Suso-Martí 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. — View Citation

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). pii: 2513. doi: 10.3390/ijerph18052513. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Baseline
Primary	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".	6 weeks after surgery
Primary	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".	6 months after surgery
Primary	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.	Baseline
Primary	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.	6 weeks after surgery
Primary	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.	6 months after surgery
Secondary	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.	Baseline
Secondary	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.	6 weeks after surgery
Secondary	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.	6 months after surgery
Secondary	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.	Baseline
Secondary	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.	6 weeks after surgery
Secondary	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.	6 months after surgery
Secondary	Joint Range of Motion	Active knee flexion and extension angle will be evaluated.	Baseline
Secondary	Joint Range of Motion	Active knee flexion and extension angle will be evaluated.	6 weeks after surgery
Secondary	Joint Range of Motion	Active knee flexion and extension angle will be evaluated.	6 months after surgery
Secondary	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.	Baseline
Secondary	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.	6 weeks after surgery
Secondary	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.	6 months after surgery
Secondary	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.	Baseline
Secondary	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.	6 weeks after surgery
Secondary	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.	6 months after surgery
Secondary	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.	Baseline
Secondary	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.	6 weeks after surgery
Secondary	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.	6 months after surgery
Secondary	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'.	Baseline
Secondary	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'.	6 weeks after surgery
Secondary	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'.	6 months after surgery
Secondary	Laterality task	Right-left discrimination will be evaluated using the Recognise™ application. The percentage of correct answers and reaction time will be recorded.	Baseline
Secondary	Laterality task	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
Secondary	Laterality task	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
Secondary	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".	Baseline
Secondary	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".	6 weeks after surgery
Secondary	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".	6 months after surgery
Secondary	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.	Baseline
Secondary	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.	6 weeks after surgery
Secondary	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.	6 months after surgery