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IRCT20221017056212N1 IRCT 2023-05-20 University of social welfare and rehabilitation sciences Evaluation of the effect of orthoses in subjects with medial compartment knee osteoarthrtis. Evaluation of the effect of orthoses by applying direct biomechanical force in comparison with orthoses applying indirect biomechanical effect on knee pain, function, satisfaction, and knee joint alignment in individuals with medial compartment knee osteoarthritis. 2022-11-22 anticipated 30 Complete https://irct.ir/trial/66361 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Medial Knee Osteoarthritis. Intervention 1: 1 Intervention group : Unloader brace It is used in patients with osteoarthritis of the internal compartment of the knee. The knee brace reduces the load from the internal compartment by creating a force of three pressure points by stretching the strap. The force of three pressure points reduces the pressure from the inner side of the knee by reducing the length of the lever arm, the force of the ground reaction and the subsequent reduction of the internal torque on the knee joint. The valgus knee brace used in this study has an internal load, crossed straps (applying external force), two loops, one in the thigh area and the other in the leg area, made of polypropylene, which are connected through a dynamic joint. Be Two-thirds of the femur at the top and the tibia at the bottom are covered by the orthosis. To make a knee brace in three sizes, we have a circumference from the peak of the cuff muscles, the circumference of the knee joint and 17 cm above the knee. The knee orthosis will be made individually and custom made for each patient based on three sizes. Intervention 2: 2 Intervention group : Lateral wedge insole, Pre-made insoles will be given to patients based on their foot size. According to the studies, the insole covers the entire length of the sole of the foot, has arch support and 6 mm external wedge. In this study, a prefabricated insole with a 6-degree outer wedge made of cork material similar to thermocork with a density of 60 per meter will be used, which will be placed in the patient's comfortable walking shoes. Intervention 3: 3 Intervention group : Ankle foot orthosis, It is custom-made for each person, and in order to create valgus torque, an external wedge will be installed under the surface of the foot. Molding is done from each person's foot. Then, the mold is ready to be drawn after making the necessary corrections. The sheet used in this orthosis is made of polyethylene and is drawn on a mold made of each person's foot. The foot-ankle orthosis prevents the external rotation of the tibia by keeping the ankle joint and the tibia vertical, and we expect that by preventing the external rotation of the tibia, the lever arm of the ground reaction force will decrease as a result of the adductor torque on the knee joint. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Maede Mahmoodi
Kodakyar Evi, Daneshjoo Blvd, Evin.
Tehran Iran (Islamic Republic of) 1985713871 +98 911 385 7516 Mahmoodi.maede93@yahoo.com University of social welfare and rehabilitation sciences scientific Maede Mahmoodi
No. 60, sq Ozgol.
Tehran Iran (Islamic Republic of) 1985713871 +98 911 385 7516 Mahmoodi.maede93@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Age between 30 and 65 years. According to radiological findings, the medial compartment of the knee should be in grade 2 or 3 based on the Kellgren- Lawrence scale. Patients should not have movement restrictions in walking and standing. Patients can walk without any help. 30 years 65 years Both Varicose veins and other diseases that affect the gait. History of recent knee injuries Neurological diseases diagnosed by a doctor. Ligamentous problems in the knee - torn meniscus. Inability to wear shoes (less than eight hours a day). M17.0 Bilateral primary osteoarthritis of knee Treatment - Devices Treatment - Devices Treatment - Devices 1 Intervention group : Unloader brace It is used in patients with osteoarthritis of the internal compartment of the knee. The knee brace reduces the load from the internal compartment by creating a force of three pressure points by stretching the strap. The force of three pressure points reduces the pressure from the inner side of the knee by reducing the length of the lever arm, the force of the ground reaction and the subsequent reduction of the internal torque on the knee joint. The valgus knee brace used in this study has an internal load, crossed straps (applying external force), two loops, one in the thigh area and the other in the leg area, made of polypropylene, which are connected through a dynamic joint. Be Two-thirds of the femur at the top and the tibia at the bottom are covered by the orthosis. To make a knee brace in three sizes, we have a circumference from the peak of the cuff muscles, the circumference of the knee joint and 17 cm above the knee. The knee orthosis will be made individually and custom made for each patient based on three sizes. 2 Intervention group : Lateral wedge insole, Pre-made insoles will be given to patients based on their foot size. According to the studies, the insole covers the entire length of the sole of the foot, has arch support and 6 mm external wedge. In this study, a prefabricated insole with a 6-degree outer wedge made of cork material similar to thermocork with a density of 60 per meter will be used, which will be placed in the patient's comfortable walking shoes. 3 Intervention group : Ankle foot orthosis, It is custom-made for each person, and in order to create valgus torque, an external wedge will be installed under the surface of the foot. Molding is done from each person's foot. Then, the mold is ready to be drawn after making the necessary corrections. The sheet used in this orthosis is made of polyethylene and is drawn on a mold made of each person's foot. The foot-ankle orthosis prevents the external rotation of the tibia by keeping the ankle joint and the tibia vertical, and we expect that by preventing the external rotation of the tibia, the lever arm of the ground reaction force will decrease as a result of the adductor torque on the knee joint. Pain/ Alignment/ Function. Timepoint: Before intervention/ After 6 weeks. Method of measurement: Angle measurement using images of bony promineces for alignment of knee/Knee injury and osteoarthritis outcome score. Aging Research Center Approved 2021-10-27 University of Social welfare and Rehabilitation Kodakyar Ave, Danshjo Blvd, Evin. Tehran Tehran Iran (Islamic Republic of)