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IRCT20250822066950N1 IRCT 2025-10-10 Iran University of Medical Sciences Comparative study of the effect of knee brace and GMI on knee osteoarthritis Investigating the effect of knee unloader brace compared to graded motor imagery on pain, function, range of motion, position sense, quality of life and and pain persistence in patients with knee osteoarthritis 2025-09-06 anticipated 24 Complete https://irct.ir/trial/85751 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, 24 people will be enrolled and randomly assigned to one of three groups (each group has eight members). We will write the name and number of each person and put them in a box. Before drawing the names from the box, we will decide that the first eight people whose names are drawn from the box will be assigned to the combined therapy intervention group. The second eight will be assigned to the knee brace control group, and the last eight will be assigned to the Graded motor imagery control group. Thus, a lottery is held and the groups are filled in order. Then, the patients will be contacted and the interventions will begin. N/A Knee osteoarthritis. Intervention 1: Intervention group: The group received a combination of Graded motor imagery(GMI) and a knee Unloader brace. Graded motor imagery is a treatment program that aims to sequentially activate the premotor and primary motor cortex through three stages: lateral recognition, explicit motor imagery, and mirror therapy. This method was identified as a therapeutic approach to address pain and functional issues in patients with chronic complex regional pain syndrome, but has since been used for other complex pain and movement disorders. In the present study, this method was implemented in people with knee osteoarthritis. It includes three stages of lateral recognition (weeks 1 and 2), imagined movements of the affected limb (weeks 3 and 4), and mirror therapy (weeks 5 and 6), which are carried out for 6 weeks.In the lateral diagnosis stage, the patient is shown a bank of limb images twice a day, and the patient must determine whether the limb is left or right in less than two seconds and practice this for 15 minutes daily. In the second stage, the patient must imagine performing movements such as walking and running, etc., twice a day, for 15 minutes each time. In the third stage, knee strengthening exercises are performed by the patient's healthy leg in front of a mirror, and the injured leg is hidden behind the mirror. This is also done for ten minutes a day for two weeks. This method is done by myself, and the implementation of this method is not exclusive to a particular company or institution, and according to articles, the method has validity and reliability. During these six weeks, knee brace treatment will also be used simultaneously. A knee unloader brace is a type of knee brace that can provide stability, support, and pain relief from knee osteoarthritis, which mainly affects only one side of the knee joint. This unloader brace is designed to transfer or reduce the load from one side of the joint to the other. In other words, a unloader brace does what its name suggests, transferring stress from the injured side of the joint to the healthy side. Wearing a unloader brace may provide enough comfort to improve mobility and reduce pain during rest. In the present study, a brace with a structure based on an aluminum joint located on the inside of the knee is used by thermoplastic shells, one of which is placed on the thigh and the other on the shin, which are placed on the individual's leg by straps and a cross-shaped elastic strap creates a tensioning effect to transfer the load and reduce it to the opposite side. This brace is made for the individual by accurately measuring the height of the leg, the location of the knee axis, and the circumference of the thigh and knee and is worn on the knee for six weeks. It is also important to note that the knee brace is made for each person based on their body shape and the principles of design and construction, which is made, tested and fitted on the patient's body by an orthotist (myself), and no specific company or manufacturer makes it and it is personalized. The knee brace is worn full-time for 6 weeks. Intervention 2: Control group 1: Group with Graded motor imagery treatment Graded motor imagery is a treatment program that aims to sequentially activate the premotor and primary motor cortex through three phases: lateral recognition, explicit motor imagery, and mirror therapy. This method was identified as a therapeutic approach to address pain and functional issues in patients with chronic complex regional pain syndrome, but has since been used for other complex pain and movement disorders. In the present study, this method was implemented in people with knee osteoarthritis. It includes three phases of lateral recognition (weeks 1 and 2), imagined movements of the affected limb (weeks 3 and 4), and mirror therapy (weeks 5 and 6), which are carried out for 6 weeks.In the lateral diagnosis stage, the patient is shown a bank of limb images twice a day, and the patient must determine whether the limb is left or right in less than two seconds and practice this for 15 minutes daily. In the second stage, the patient must imagine performing movements such as walking and running, etc., twice a day, for 15 minutes each time. In the third stage, knee strengthening exercises are performed by the patient's healthy leg in front of a mirror, and the injured leg is hidden behind the mirror. This is also done for ten minutes a day for two weeks. This method is done by myself, and the implementation of this method is not exclusive to a particular company or institution, and according to articles, the method has validity and reliability. Intervention 3: Control group 2: Group with treatment of Unloader knee brace An unloader knee brace is a type of brace that can provide stability, support, and pain relief from osteoarthritis of the knee, which typically affects only one side of the knee joint. The brace is designed to transfer or reduce the load from one side of the joint to the other. In other words, An unloader knee brace does exactly what its name suggests, it transfers stress from the affected side of the joint to the healthier side. The use of a knee brace may provide sufficient comfort to improve mobility and reduce pain during rest. In the present study, a load-reducing knee brace with a structure based on an aluminum joint located on the inside of the knee and supported by thermoplastic shells, one of which is located on the thigh and the other on the shin, is used. The shells are placed on the individual's leg with straps and a cross-shaped elastic strap creates a tensioning effect to transfer the load and reduce it to the opposite side.This knee brace is made for the individual by accurately measuring the height of the leg, the location of the knee axis and the circumference of the thigh and knee And it is worn on the knee for six weeks. It is also important to note that the knee brace is made for each person based on their body shape and the principles of design and construction, which is made, tested and fitted on the patient's body by an orthotist (myself), and no specific company or manufacturer makes it and it is personalized. The knee brace is worn full-time for 6 weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access period begins one year after results are published. To whom: For researchers only Conditions: In order to advance science and contribute to similar research Where to obtain: gelarerazavii@gmail.com How to obtain: The researcher should explain their research intentions and methods to the aforementioned email. Comments:
public Seyede Gelare Razavi Khorasani
No. 82،Rahmani St، Javanmardan Blvd .
Tehran Iran (Islamic Republic of) 1487734381 +98 21 4413 8605 gelarerazavii@gmail.com Iran University of Medical Sciences scientific Seyede Gelare Razavi Khorasani
No 82 ،Rahmani ST، Javanmardan Blvd
Tehran Iran (Islamic Republic of) 1487734381 +98 21 4413 8605 gelarerazavii@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Knee osteoarthritis grade 2 and 3 according to the Kellgren-Lawrence grading system Age range 40 years to 65 years (middle age) based on the new age range division 40 years 65 years Both previous experience with knee surgery M17.1 Unilateral primary osteoarthritis of knee Rehabilitation Rehabilitation Treatment - Devices Intervention group: The group received a combination of Graded motor imagery(GMI) and a knee Unloader brace. Graded motor imagery is a treatment program that aims to sequentially activate the premotor and primary motor cortex through three stages: lateral recognition, explicit motor imagery, and mirror therapy. This method was identified as a therapeutic approach to address pain and functional issues in patients with chronic complex regional pain syndrome, but has since been used for other complex pain and movement disorders. In the present study, this method was implemented in people with knee osteoarthritis. It includes three stages of lateral recognition (weeks 1 and 2), imagined movements of the affected limb (weeks 3 and 4), and mirror therapy (weeks 5 and 6), which are carried out for 6 weeks.In the lateral diagnosis stage, the patient is shown a bank of limb images twice a day, and the patient must determine whether the limb is left or right in less than two seconds and practice this for 15 minutes daily. In the second stage, the patient must imagine performing movements such as walking and running, etc., twice a day, for 15 minutes each time. In the third stage, knee strengthening exercises are performed by the patient's healthy leg in front of a mirror, and the injured leg is hidden behind the mirror. This is also done for ten minutes a day for two weeks. This method is done by myself, and the implementation of this method is not exclusive to a particular company or institution, and according to articles, the method has validity and reliability. During these six weeks, knee brace treatment will also be used simultaneously. A knee unloader brace is a type of knee brace that can provide stability, support, and pain relief from knee osteoarthritis, which mainly affects only one side of the knee joint. This unloader brace is designed to transfer or reduce the load from one side of the joint to the other. In other words, a unloader brace does what its name suggests, transferring stress from the injured side of the joint to the healthy side. Wearing a unloader brace may provide enough comfort to improve mobility and reduce pain during rest. In the present study, a brace with a structure based on an aluminum joint located on the inside of the knee is used by thermoplastic shells, one of which is placed on the thigh and the other on the shin, which are placed on the individual's leg by straps and a cross-shaped elastic strap creates a tensioning effect to transfer the load and reduce it to the opposite side. This brace is made for the individual by accurately measuring the height of the leg, the location of the knee axis, and the circumference of the thigh and knee and is worn on the knee for six weeks. It is also important to note that the knee brace is made for each person based on their body shape and the principles of design and construction, which is made, tested and fitted on the patient's body by an orthotist (myself), and no specific company or manufacturer makes it and it is personalized. The knee brace is worn full-time for 6 weeks. Control group 1: Group with Graded motor imagery treatment Graded motor imagery is a treatment program that aims to sequentially activate the premotor and primary motor cortex through three phases: lateral recognition, explicit motor imagery, and mirror therapy. This method was identified as a therapeutic approach to address pain and functional issues in patients with chronic complex regional pain syndrome, but has since been used for other complex pain and movement disorders. In the present study, this method was implemented in people with knee osteoarthritis. It includes three phases of lateral recognition (weeks 1 and 2), imagined movements of the affected limb (weeks 3 and 4), and mirror therapy (weeks 5 and 6), which are carried out for 6 weeks.In the lateral diagnosis stage, the patient is shown a bank of limb images twice a day, and the patient must determine whether the limb is left or right in less than two seconds and practice this for 15 minutes daily. In the second stage, the patient must imagine performing movements such as walking and running, etc., twice a day, for 15 minutes each time. In the third stage, knee strengthening exercises are performed by the patient's healthy leg in front of a mirror, and the injured leg is hidden behind the mirror. This is also done for ten minutes a day for two weeks. This method is done by myself, and the implementation of this method is not exclusive to a particular company or institution, and according to articles, the method has validity and reliability. Control group 2: Group with treatment of Unloader knee brace An unloader knee brace is a type of brace that can provide stability, support, and pain relief from osteoarthritis of the knee, which typically affects only one side of the knee joint. The brace is designed to transfer or reduce the load from one side of the joint to the other. In other words, An unloader knee brace does exactly what its name suggests, it transfers stress from the affected side of the joint to the healthier side. The use of a knee brace may provide sufficient comfort to improve mobility and reduce pain during rest. In the present study, a load-reducing knee brace with a structure based on an aluminum joint located on the inside of the knee and supported by thermoplastic shells, one of which is located on the thigh and the other on the shin, is used. The shells are placed on the individual's leg with straps and a cross-shaped elastic strap creates a tensioning effect to transfer the load and reduce it to the opposite side.This knee brace is made for the individual by accurately measuring the height of the leg, the location of the knee axis and the circumference of the thigh and knee And it is worn on the knee for six weeks. It is also important to note that the knee brace is made for each person based on their body shape and the principles of design and construction, which is made, tested and fitted on the patient's body by an orthotist (myself), and no specific company or manufacturer makes it and it is personalized. The knee brace is worn full-time for 6 weeks. Pain. Timepoint: Before the intervention, immediately after the end of the last intervention, one month after the end of the last intervention. Method of measurement: Visual Analog Scale Questionnaire and Western Ontario and McMaster Universities Arthritis Indext Questionnaire. Function. Timepoint: Before the intervention, immediately after the end of the last intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Indext Questionnaire. Range of motion. Timepoint: Before the intervention, immediately after the end of the last intervention. Method of measurement: Goniometer. Quality of life. Timepoint: Before the intervention, immediately after the end of the last intervention. Method of measurement: SF36 Questionnaire. Position sense. Timepoint: Before the intervention, immediately after the end of the last intervention. Method of measurement: Manual Situational Awareness Assessment Test. Iran University of Medical Sciences Approved 2025-05-13 Ethics Committee of Iran University of Medical Sciences Central Building, Iran University of Medical Sciences, Next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)