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Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensorimotor Exercise
Conventional Exercise
Progressive Motor Imagery Exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring rehabilitation, motor imagery training, sensorimotor training, balance, functional performance

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR), Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria, Between the ages of 50 and 65, Body mass index below 35 kg/m², Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS, There are no obstacles to being included in the exercise program, Patients with a score of at least 24 on the Standardized Mini Mental Test will be included. Exclusion Criteria: Receiving any physiotherapy program or injection treatment in the last 3 months, Having a diagnosis of additional pathology other than OA in the knee, having a history of knee injury / surgery in the past Having uncontrollable hypertension, cardiovascular and neurological diseases that will prevent exercise, The patient has any vision, hearing or cognitive problems that will prevent him from complying with the treatment, Providing ambulation with an assistive device

Sites / Locations

  • Ebru KaradüzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Sensorimotor Exercise Training

Progressive Motor Imagery Training

Conventional Exercise Training

Arm Description

Sensorimotor exercise content has been prepared based on previous sensorimotor, balance and proprioceptive studies in the literature. It is organized as a structured traditional exercise program + SM training content.

In order to sequentially activate the cortical motor networks and improve cortical organization, a literature-supported program including the components of AMI training (first stage laterality training, second stage motor imagery and third stage mirror therapy) was prepared and a six-week structured exercise program suitable for knee joint treatment + AMI training was prepared.

A 6-week program was prepared from traditional treatment exercises based on previous studies in knee osteoarthritis. It consists of progressive muscle strengthening of Quadriceps, Hamstrings and gluteals and also stretching exercises.

Outcomes

Primary Outcome Measures

Balance
For balance and fall risk assessment, the Biodex Balance System (BBS) (Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York) will be used. Computer result will be used to see falling risk and stability postural problems as anteroposterior and mediolateral. In the evaluation, while the patient stands without shoes on the BBS platform, the patients are asked to place their feet on the marked place, hold the BBS monitor and focus. The patient is asked to keep the cursor on the screen in the smallest circle shown on the device screen for 20 seconds while applying surface movements that can move between 20 and 360 degrees that will disrupt postural stability at different levels (12 most stable, 1 most mobile). Based on previous studies, the static assessment will be assessed at level 12, and the dynamic assessment and risk of falling will be assessed at level 8.

Secondary Outcome Measures

Pain of joint
The Numerical Rating Pain Scale (NPRS) is frequently used to measure and monitor the severity of pain. Absence of pain is defined by 0 and excruciating pain by 10.
Proprioception
The passive-active angle repetition test is often preferred to evaluate proprioception. In this test, the knee is moved (actively or passively) toward a specified target angle with the patient's eyes open. After a few seconds, the knee is returned to the starting position and the target angle is repeated. Following this, the patient is asked to reconstruct the perceived angle with the same knee while his eyes are closed, and how much the knee joint deviates from the target angle is calculated. The error will be recorded as deviated angle .

Full Information

First Posted
March 18, 2023
Last Updated
June 10, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05850793
Brief Title
Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis
Official Title
Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Osteoarthritis is the most common type of arthritis, which can affect all joints in the body and includes synovial inflammation, cartilage degeneration, osteophyte formation and bone remodeling in its pathophysiology. Many approaches are used in its treatment, and the effectiveness of exercise in conservative treatment has been proven. Many exercise methods such as strengthening, balance, aquatherapy are applied, but there is no definite consensus on exercise prescribing.Programs that focus on restoring balance and proprioception are called "sensorimotor or neuromuscular trainings". Previous studies have shown that neuromuscular exercises reduce pain, improve function, improve balance, and cause positive biomechanical changes in knee osteoarthritis and meniscus injuries. Progressive Motor Imagery (AMI) is an approach in rehabilitation where the focus is on progressive brain exercise. It is an education that approaches patients with pain, activity limitation and functional loss with a holistic view within the framework of the biopsychosocial model. The aim of this study; to examine the effects of two current treatment programs (AMI, SM training) on symptoms, functionality, balance and proprioception parameters in osteoarthritis rehabilitation.
Detailed Description
Osteoarthritis (OA) is the most common arthritis, affecting more than 300 million adults worldwide. The pathophysiology of OA, which can affect all joints in the body, includes synovial inflammation, cartilage degeneration, osteophyte formation, and bone remodeling. These changes in OA, a chronic and degenerative joint disease, impair joint stability and function, causing pain. With the deterioration of the dynamic balance between production and destruction in the articular cartilage and subchondral bone, the joint becomes unable to meet the load . The knee joint is the most commonly affected joint in the body by OA; it also ranks eleventh among the leading causes of global disability. Typically, patients with knee OA experience pain, swelling, decreased muscle strength (especially the quadriceps femoris), joint stiffness, and loss of function Therapeutic exercise, weight control in obese patients, self-efficacy and self-management programs, use of orthoses, topical and oral nonsteroidal anti-inflammatory drugs, intra-articular injections, radiofrequency and surgical methods are used in the management of knee OA. The primary treatment in the treatment of OA is to prefer conservative practices such as exercise and education . Progressive Motor Imagery (AMI) is an approach in rehabilitation where the focus is on progressive brain exercise. It is an education that approaches patients with pain, activity limitation and functional loss with a holistic view within the framework of the biopsychosocial model. It consists of three components in turn: Laterality training (left-right discrimination training), motor imagery (imagining movements), and the third step mirror therapy (providing visual feedback through the mirror). Laterality (closed imagery) is the process of determining whether a limb is a left or right limb, or that the patient is turning right or left for the spine. Motor imagery (open imagery) is the patient's internal, external and kinesthetic imagining of their movements and postures. Mirror therapy (visual feedback) refers to the use of a mirror to present an inverted image of a limb, thereby tricking the brain. By following these three steps, it is aimed to sequentially activate cortical motor networks and improve cortical organization. The aim of our study; to examine the effects of two current treatment programs (AMI, SM training) on symptoms, functionality, balance and proprioception parameters in osteoarthritis rehabilitation. The study is a prospective, three arm ,randomized controlled trial. A total participant number was calculated with Gpower as 54 patients with %90 power. There will be 3 groups and participants will perform the exercises which included their group 2 times a week for 6 weeks, accompanied by a physiotherapist.Each group includes 18 patients. Evaluations will be made at the start of treatment, at 6th weeks and 12th weeks after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
rehabilitation, motor imagery training, sensorimotor training, balance, functional performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
participants and the researcher who evaluated the analysis are blind to the study
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensorimotor Exercise Training
Arm Type
Experimental
Arm Description
Sensorimotor exercise content has been prepared based on previous sensorimotor, balance and proprioceptive studies in the literature. It is organized as a structured traditional exercise program + SM training content.
Arm Title
Progressive Motor Imagery Training
Arm Type
Experimental
Arm Description
In order to sequentially activate the cortical motor networks and improve cortical organization, a literature-supported program including the components of AMI training (first stage laterality training, second stage motor imagery and third stage mirror therapy) was prepared and a six-week structured exercise program suitable for knee joint treatment + AMI training was prepared.
Arm Title
Conventional Exercise Training
Arm Type
Active Comparator
Arm Description
A 6-week program was prepared from traditional treatment exercises based on previous studies in knee osteoarthritis. It consists of progressive muscle strengthening of Quadriceps, Hamstrings and gluteals and also stretching exercises.
Intervention Type
Behavioral
Intervention Name(s)
Sensorimotor Exercise
Intervention Description
Balance, perturbation , aging and strengthing exercise will be performed for knee
Intervention Type
Behavioral
Intervention Name(s)
Conventional Exercise
Other Intervention Name(s)
traditional exercise for osteoarthritis
Intervention Description
Range of motion, strengthing and stretching exercise will be performed for knee
Intervention Type
Behavioral
Intervention Name(s)
Progressive Motor Imagery Exercise
Intervention Description
Different types of exercises will be applied targeting muscle strength, proprioceptive sense or brain neurons for knee
Primary Outcome Measure Information:
Title
Balance
Description
For balance and fall risk assessment, the Biodex Balance System (BBS) (Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York) will be used. Computer result will be used to see falling risk and stability postural problems as anteroposterior and mediolateral. In the evaluation, while the patient stands without shoes on the BBS platform, the patients are asked to place their feet on the marked place, hold the BBS monitor and focus. The patient is asked to keep the cursor on the screen in the smallest circle shown on the device screen for 20 seconds while applying surface movements that can move between 20 and 360 degrees that will disrupt postural stability at different levels (12 most stable, 1 most mobile). Based on previous studies, the static assessment will be assessed at level 12, and the dynamic assessment and risk of falling will be assessed at level 8.
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks
Secondary Outcome Measure Information:
Title
Pain of joint
Description
The Numerical Rating Pain Scale (NPRS) is frequently used to measure and monitor the severity of pain. Absence of pain is defined by 0 and excruciating pain by 10.
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Title
Proprioception
Description
The passive-active angle repetition test is often preferred to evaluate proprioception. In this test, the knee is moved (actively or passively) toward a specified target angle with the patient's eyes open. After a few seconds, the knee is returned to the starting position and the target angle is repeated. Following this, the patient is asked to reconstruct the perceived angle with the same knee while his eyes are closed, and how much the knee joint deviates from the target angle is calculated. The error will be recorded as deviated angle .
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Other Pre-specified Outcome Measures:
Title
Functional Evaluation
Description
The Western Ontario and McMaster Universities Osteoarthritis Index; It was developed specifically for OA in order to determine the physical function levels of patients based on their own reports. In the literature, it is seen that the WOMAC score is frequently used to evaluate the functional status of daily life in patients with OA. Translation of WOMAC into Turkish, validity and reliability studies were carried out. In the scale consisting of 24 questions and 3 subsections, the first section evaluates pain (5 questions), the second section evaluates joint stiffness (2 questions), and the third section evaluates the level of difficulty experienced by the patient while performing physical functions (17 questions). The scale scores is reported between 0 to 100 point and high scores show worse outcome..
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Title
Range of Motion
Description
Goniometric measurement is an objective method that is frequently used in the evaluation of joint range of motion (ROM). Universal goniometer will be used for all measurements in the study. Flexion and extension ROM measurements of both knee joints will be measured in all patients, and arithmetic mean values will be recorded by repeating each measurement three times. The result will be record as angle.
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Title
Cognitive status
Description
Cognitive status assessment will be made using the Standardized Mini Mental Test (Mini Mental State Examination, MMSE). It is a test consisting of 30 questions and evaluated over 30 points, providing data about cognitive status by evaluating cognitive functions such as orientation, memory, calculation, speaking, and drawing a complex polygon. High Scores shows better cognitive status.
Time Frame
only at baseline evaluation for inclusion criteria (MMSE ≥ 24 point)
Title
Mobility
Description
The Timed Up and Go Test is a test used to evaluate the mobility of the patient. It measures the time it takes for a participant to stand up from a comfortable 45-cm-high chair, walk 3 meters quickly, cross the line on the floor, turn, walk back to the chair, and sit down. The participant is encouraged to do the test very quickly. High scores shows worse outcome.
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Title
Lateralization
Description
Lateralization will be evaluated with the Recognise™ application developed by the "Neuro Orthapaedic Institute". Recognise™ is a valid and reliable application used to measure lateralization speed and accuracy (37). Separate applications have been developed for neck, waist, knee, foot, shoulder and hand. Application result will be used as accuracy rates (%) and speed as time.
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Title
Patient Satisfaction
Description
Patient satisfaction will be evaluated with the Global Rating of Change (GRC) as a score between -2 to 2 point. Lower score shows worse satisfaction outcome.
Time Frame
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR), Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria, Between the ages of 50 and 65, Body mass index below 35 kg/m², Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS, There are no obstacles to being included in the exercise program, Patients with a score of at least 24 on the Standardized Mini Mental Test will be included. Exclusion Criteria: Receiving any physiotherapy program or injection treatment in the last 3 months, Having a diagnosis of additional pathology other than OA in the knee, having a history of knee injury / surgery in the past Having uncontrollable hypertension, cardiovascular and neurological diseases that will prevent exercise, The patient has any vision, hearing or cognitive problems that will prevent him from complying with the treatment, Providing ambulation with an assistive device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EBRU KARADÜZ, MSc
Phone
+905346434872
Email
ebrugulek94@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sena TOLU, Assist Prof
Phone
05054424722
Email
stolu@medipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EBRU KARADÜZ, PhD(c)
Organizational Affiliation
İstanbul Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sena TOLU, Asist Prof
Organizational Affiliation
Medipol Mega Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Candan Algun, Prof
Organizational Affiliation
İstanbul Medipol University
Official's Role
Study Chair
Facility Information:
Facility Name
Ebru Karadüz
City
Fatih
State/Province
Istanbul
ZIP/Postal Code
34083
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EBRU KARADÜZ, MSc
Phone
05346434872
Email
ebrugulek94@gmail.com
First Name & Middle Initial & Last Name & Degree
Sena Tolu, Asist Prof
Phone
05054424722
Email
stolu@medipol.edu.tr

12. IPD Sharing Statement

Citations:
PubMed Identifier
21665124
Citation
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Results Reference
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PubMed Identifier
26405113
Citation
Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
Results Reference
background
PubMed Identifier
24553908
Citation
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
Results Reference
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PubMed Identifier
33406330
Citation
Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
Results Reference
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PubMed Identifier
19762361
Citation
Zhang W, Doherty M, Peat G, Bierma-Zeinstra MA, Arden NK, Bresnihan B, Herrero-Beaumont G, Kirschner S, Leeb BF, Lohmander LS, Mazieres B, Pavelka K, Punzi L, So AK, Tuncer T, Watt I, Bijlsma JW. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Ann Rheum Dis. 2010 Mar;69(3):483-9. doi: 10.1136/ard.2009.113100. Epub 2009 Sep 17.
Results Reference
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PubMed Identifier
29525292
Citation
Dominguez-Navarro F, Igual-Camacho C, Silvestre-Munoz A, Roig-Casasus S, Blasco JM. Effects of balance and proprioceptive training on total hip and knee replacement rehabilitation: A systematic review and meta-analysis. Gait Posture. 2018 May;62:68-74. doi: 10.1016/j.gaitpost.2018.03.003. Epub 2018 Mar 5.
Results Reference
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PubMed Identifier
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Citation
Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.
Results Reference
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PubMed Identifier
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Citation
Baird CL, Sands L. A pilot study of the effectiveness of guided imagery with progressive muscle relaxation to reduce chronic pain and mobility difficulties of osteoarthritis. Pain Manag Nurs. 2004 Sep;5(3):97-104. doi: 10.1016/j.pmn.2004.01.003.
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PubMed Identifier
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Citation
Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6. Erratum In: Arthritis Care Res (Hoboken). 2021 May;73(5):764.
Results Reference
result

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Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis

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