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临床试验/NCT05850793
NCT05850793招募中不适用

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

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
2
主要终点
Balance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

participants and the researcher who evaluated the analysis are blind to the study

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Balance

时间窗: 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.

次要结局

  • Proprioception(change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week)
  • Pain of joint(change from baseline to posttreatment 6th weeks , change from posttratment 6th weeks to 12th week)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ebru gulek karaduz

Physiotherapist (MSc ) / PhD (continous) / Lecturer Ebru Gülek Karadüz

Istanbul Medipol University Hospital

研究点 (2)

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