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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Inonu Unıversity

    Malatya

    Busra CANDIRI, 05073780717

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05138406
Study groupRoleWhat they receive
Graded Motor ImageryExperimentalIndividuals will receive standard rehabilitation and graded motor imagery treatment.
Receives: Other: Graded Motor Imagery; Other: Standard Rehabilitation
Standard Rehabilitation GroupActive comparatorStandard 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Joint Range of Motion

    Active knee flexion and extension angle will be evaluated.

    Measured: Baseline

  8. Joint Range of Motion

    Active knee flexion and extension angle will be evaluated.

    Measured: 6 weeks after surgery

  9. Joint Range of Motion

    Active knee flexion and extension angle will be evaluated.

    Measured: 6 months after surgery

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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.

  1. First posted1 Dec 2021
  2. Study start28 Feb 2022
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

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)
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 29908933
  • 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.

    PubMed 29122370
  • 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.

    PubMed 33128533
  • 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.

    PubMed 33802559

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.

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