]>
IRCT20181210041914N2 IRCT 2023-04-30 Bu-Ali Sina University of Hamedan The effect of lateral wedge sock insoles on the gait of patients with knee arthritis Biomechanical analysis of the gait of patients with knee osteoarthritis before and after the acute use of the lateral wedge sock insoles 2023-04-30 anticipated 60 Complete https://irct.ir/trial/69762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the restricted randomization method of block randomization to balance the number of samples assigned to each group. Specifically, we will form 6 blocks of equal size, each containing 3 participants (3 in the intervention group and 3 in the control group). To generate the random sequence, we will use a software called Random Allocation Software, which can perform both simple randomization and blocking. We will also use concealment allocation to ensure that the assigned group of each participant remains unknown until the moment of assignment. To achieve this, we will use opaque sealed envelopes containing a sequentially numbered random sequence generated on a registration card. The cards themselves will be placed in letter envelopes in order. In order to maintain the randomized sequence, the outer surface of the envelopes will be numbered in the same order. Finally, we will glue the lid of each envelope and place them in a box. When we begin registering participants, we will open an envelope based on the order of entry of eligible participants into the study, revealing the assigned group for that participant, Blinding description: In this study, 60 patients will participate, who will be randomly divided into two control and experimental groups (according to the explanation in the previous section). The intervention group will receive a 6-degree lateral wedge sock insole and the control group will receive a 0-degree neutral insole as a placebo. The insoles will be provided to the participants by the clinical supervisor. Neither the participants nor the researchers and the members of the analysis and evaluation team will know which group received the intervention. N/A Medial Compartment Knee Osteoarthritis. Intervention 1: Intervention group: Using the lateral wedge sock insoles; The insole used in this study is designed as a sock for easy use at home without the need for shoes or sandals. As previous research has shown that the 6-degree insole is most effective in reducing pain and improving performance in patients, A 6-degree lateral wedge was selected. The stiffness of the sole will vary from hard on the lateral edge to softer on the medial side. The lateral part will be made of Plastazote foam with a hardness of A: 70, while the medial part will be made of Ethylene-vinyl acetate (EVA) with a hardness of A: 20. The insole supports both the internal longitudinal arch and the transverse arch of the foot to maximize patient comfort. Additionally, a subtalar strap will be used to prevent eversion behind the heel. The upper part of the insole will be made of soft material to ensure patient comfort. The affected foot will use a 6-degree lateral wedge insole, while a 0-degree neutral insole will be used for healthy feet to prevent leg length discrepancy. Intervention 2: Control group: For the control group, a zero-degree neutral insole will be used as a placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is This file is confidential.
public Fereshteh Sabet
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Bo Ali Sina University
Hamedan Iran (Islamic Republic of) 6517833131 +98 41 4225 0314 fereshteh_sabet@yahoo.com Bu-Ali Sina university scientific Fershteh Sabet
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Bu Ali Sina University
Hamedan Iran (Islamic Republic of) 6517833131 +98 41 4225 0314 fereshteh_sabet@yahoo.com Bu-Ali Sina University Iran (Islamic Republic of) age range of 40 to 65 years having radiological signs of mild to moderate osteoarthritis in the knee chronic knee pain for 1 month or more morning stiffness for less than 30 minutes Crepitus 40 years 65 years Both The presence of any pain or lesion in the lower limb (except knee osteoarthritis) Use of stimulants, drugs and alcohol History of neurological and muscle diseases The presence of any systemic disease such as rheumatism Diabetes or a history of cardiovascular and pulmonary diseases History of any surgery in the affected knee Intra-articular injection (PRP) within the last six months History of fractures and dislocations in the lower limb during the past year Having a regular exercise program in the last six months Having pain less than one day per month Inability to walk without assistance M17 Osteoarthritis of knee Rehabilitation Placebo Intervention group: Using the lateral wedge sock insoles; The insole used in this study is designed as a sock for easy use at home without the need for shoes or sandals. As previous research has shown that the 6-degree insole is most effective in reducing pain and improving performance in patients, A 6-degree lateral wedge was selected. The stiffness of the sole will vary from hard on the lateral edge to softer on the medial side. The lateral part will be made of Plastazote foam with a hardness of A: 70, while the medial part will be made of Ethylene-vinyl acetate (EVA) with a hardness of A: 20. The insole supports both the internal longitudinal arch and the transverse arch of the foot to maximize patient comfort. Additionally, a subtalar strap will be used to prevent eversion behind the heel. The upper part of the insole will be made of soft material to ensure patient comfort. The affected foot will use a 6-degree lateral wedge insole, while a 0-degree neutral insole will be used for healthy feet to prevent leg length discrepancy. Control group: For the control group, a zero-degree neutral insole will be used as a placebo. Knee OA Symptoms. Timepoint: Before and after the immediate use of the lateral wedge sock insoles. Method of measurement: WOMAC Questionnaire. Knee External Adduction Moment (EKAM). Timepoint: Before and after the immediate use of the lateral wedge sock insoles. Method of measurement: Through kinematic data obtained from motion analysis system and kinetic data obtained from the force plate. Coordination and variability of the coordinated pattern of hindfoot and the leg. Timepoint: Before and after the immediate use of the lateral wedge sock insoles. Method of measurement: Through kinematic data obtained from motion analysis System. Center of Pressure (CoP) Path. Timepoint: Before and after the immediate use of the lateral wedge sock insoles. Method of measurement: Using the data obtained from the foot scanner (Foot pressure). Bu-Ali Sina University of Hamedan Approved 2022-09-06 Research Ethics Committee of BU-Ali Sina University, Hamedan Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street Hamedan Hamadan Iran (Islamic Republic of)