Clinical trial NCT05850793: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: rehabilitation
motor imagery training
sensorimotor training
balance
functional performance
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Balance
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th weeks
Secondary outcomes:
measure: Pain of joint
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
measure: Proprioception
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Other outcomes:
measure: Functional Evaluation
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
measure: Range of Motion
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
measure: Cognitive status
timeFrame: only at baseline evaluation for inclusion criteria (MMSE ≥ 24 point)
measure: Mobility
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
measure: Lateralization
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
measure: Patient Satisfaction
timeFrame: change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week
Locations:
city: Fatih
country: Turkey
facility: Ebru Karadüz
state: Istanbul
Study officials:
affiliation: İstanbul Medipol University
name: EBRU KARADÜZ, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol Mega Hospital
name: Sena TOLU, Asist Prof
role: STUDY_CHAIR
affiliation: İstanbul Medipol University
name: Candan Algun, Prof
role: STUDY_CHAIR
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