Graded Motor Imagery and Total Knee Arthroplasty

November 10, 2022 updated by: Burcu Talu, Inonu University

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Malatya, Turkey
        • Recruiting
        • Inonu Unıversity
        • Contact:
          • Busra CANDIRI
          • Phone Number: 05073780717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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".
Baseline
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
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
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
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.
Baseline
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
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
Joint Range of Motion
Time Frame: Baseline
Active knee flexion and extension angle will be evaluated.
Baseline
Joint Range of Motion
Time Frame: 6 weeks after surgery
Active knee flexion and extension angle will be evaluated.
6 weeks after surgery
Joint Range of Motion
Time Frame: 6 months after surgery
Active knee flexion and extension angle will be evaluated.
6 months after surgery
Quadriceps muscle strength
Time Frame: Baseline
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
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
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
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
Kinesiophobia
Time Frame: 6 weeks 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 weeks after surgery
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
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.
Baseline
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
Mental chronometry delta time
Time Frame: Baseline
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
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
Laterality task
Time Frame: Baseline
Right-left discrimination will be evaluated using the Recognise™ application. The percentage of correct answers and reaction time will be recorded.
Baseline
Laterality task
Time Frame: 6 weeks after surgery
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
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.
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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