Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis

June 10, 2023 updated by: ebru gulek karaduz, Istanbul Medipol University Hospital

Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

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 Contact Backup

Study Locations

  • Turkey
    • Istanbul
      • Fatih, Istanbul, Turkey, 34083

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensorimotor Exercise Training
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.
Behavioral: Sensorimotor Exercise
Balance, perturbation , aging and strengthing exercise will be performed for knee
Behavioral: Conventional Exercise
Range of motion, strengthing and stretching exercise will be performed for knee
Other Names:
  • traditional exercise for osteoarthritis
Experimental: Progressive Motor Imagery Training
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.
Behavioral: Conventional Exercise
Range of motion, strengthing and stretching exercise will be performed for knee
Other Names:
  • traditional exercise for osteoarthritis
Behavioral: Progressive Motor Imagery Exercise
Different types of exercises will be applied targeting muscle strength, proprioceptive sense or brain neurons for knee
Active Comparator: Conventional Exercise Training
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.
Behavioral: Sensorimotor Exercise
Balance, perturbation , aging and strengthing exercise will be performed for knee
Behavioral: Conventional Exercise
Range of motion, strengthing and stretching exercise will be performed for knee
Other Names:
  • traditional exercise for osteoarthritis
Behavioral: Progressive Motor Imagery Exercise
Different types of exercises will be applied targeting muscle strength, proprioceptive sense or brain neurons for knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks

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.
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of joint
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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.
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Proprioception
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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 .
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Evaluation
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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..
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Range of Motion
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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.
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Cognitive status
Time Frame: only at baseline evaluation for inclusion criteria (MMSE ≥ 24 point)
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.
only at baseline evaluation for inclusion criteria (MMSE ≥ 24 point)
Mobility
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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.
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Lateralization
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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.
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Patient Satisfaction
Time Frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
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.
change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

Collaborators and Investigators

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

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: EBRU KARADÜZ, PhD(c), Istanbul Medipol University
  • Study Chair: Sena TOLU, Asist Prof, Medipol Mega Hospital
  • Study Chair: Candan Algun, Prof, Istanbul Medipol University

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.

General Publications

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)

May 15, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ebrugk

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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