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Osteoarthritis, KneeNCT05850793

Comparison of Progressive Motor Imagery and Sensorimotor Exercises in Knee Osteoarthritis

A study testing Sensorimotor Exercise, Conventional Exercise and Progressive Motor Imagery Exercise in people with Osteoarthritis, Knee, run by Istanbul Medipol University Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 50 to 65 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Sensorimotor Exercise, Conventional Exercise and Progressive Motor Imagery Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2023to 30 Dec 2024
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 50 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

EBRU KARADÜZ, MSc contact

+905346434872

ebrugulek94@gmail.com

Sena TOLU, Assist Prof contact

05054424722

stolu@medipol.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Ebru Karadüz

    Fatih, Istanbul, 34083

    EBRU KARADÜZ, MSc, 05346434872, ebrugulek94@gmail.com

    Sena Tolu, Asist Prof, 05054424722, stolu@medipol.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.
Being tested
Sensorimotor Exercise, Conventional Exercise, Progressive Motor Imagery Exercise
Keywords
rehabilitation, motor imagery training, sensorimotor training, balance, functional performance
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensorimotor ExerciseBehavioural

    Balance, perturbation , aging and strengthing exercise will be performed for knee

  • Conventional ExerciseBehavioural

    Also called traditional exercise for osteoarthritis

    Range of motion, strengthing and stretching exercise will be performed for knee

  • Progressive Motor Imagery ExerciseBehavioural

    Different types of exercises will be applied targeting muscle strength, proprioceptive sense or brain neurons for knee

Study groups in NCT05850793
Study groupRoleWhat they receive
Sensorimotor Exercise TrainingExperimentalSensorimotor 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.
Receives: Behavioral: Sensorimotor Exercise; Behavioral: Conventional Exercise
Progressive Motor Imagery TrainingExperimentalIn 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.
Receives: Behavioral: Conventional Exercise; Behavioral: Progressive Motor Imagery Exercise
Conventional Exercise TrainingActive comparatorA 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.
Receives: Behavioral: Sensorimotor Exercise; Behavioral: Conventional Exercise; Behavioral: Progressive Motor Imagery Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks

Secondary outcomes (2)
  1. 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.

    Measured: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

  2. 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 .

    Measured: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start15 May 2023
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Dec 2024 (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
Model description
A randomized controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05850793
Sponsor's protocol ID
ebrugk
Status last verified
Jun 2023
First submitted
18 Mar 2023
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Busija L, Bridgett L, Williams SR, Osborne RH, Buchbinder R, March L, Fransen M. Osteoarthritis. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):757-68. doi: 10.1016/j.berh.2010.11.001.

    PubMed 21665124
  • 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.

    PubMed 26405113
  • 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.

    PubMed 24553908
  • Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.

    PubMed 33406330
  • 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.

    PubMed 19762361
  • 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.

    PubMed 29525292
  • 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.

    PubMed 17082465
  • 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.

    PubMed 15359221
  • 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.

    PubMed 31908149

Questions about this trial

What is this clinical trial studying?

A study testing Sensorimotor Exercise, Conventional Exercise and Progressive Motor Imagery Exercise in people with Osteoarthritis, Knee, run by Istanbul Medipol University Hospital 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 7 inclusion and 5 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 13 Jun 2023. 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 EBRU KARADÜZ, MSc (+905346434872, ebrugulek94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance (time frame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks). 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 NCT05850793, which also lists 9 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 13 Jun 2023.

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