Biomechanical analysis of the gait of patients with knee osteoarthritis before and after the acute use of the lateral wedge sock insoles

The aim of this study is to analyze the biomechanical characteristics of gait in patients with knee osteoarthritis before and after the immediate use of lateral wedge sock insoles.

It involves a control group and parallel groups, both of which are double-blind and randomized. The trial will be conducted on 60 patients without any phases. Block randomization, using a limited randomization approach, will be employed for the purpose of randomization.

BuAli Sina University

The study will include patients between the ages of 40 and 65 who have radiographic evidence of mild to moderate knee osteoarthritis, chronic knee pain lasting for one month or more, morning stiffness of less than 30 minutes, and crepitus. Patients with lower limb pain or lesions (excluding knee osteoarthritis), those who use stimulants, drugs, or alcohol, those with a history of neurological or muscular diseases or systemic illnesses such as rheumatism, diabetes, cardiovascular, or pulmonary diseases, those who have undergone surgery on the affected knee or received intra-articular PRP injection in the past six months, those who have a history of fractures or dislocations in the lower limb within the past year, and those who have engaged in a regular exercise program in the past six months will be excluded from the study. Additionally, patients with pain lasting less than one day per month and those who cannot walk without assistance will also be excluded.

The intervention group will consist of participants who receive a specially designed sock lateral wedge insole. The control group will also comprise 30 participants who are similar to the experimental group in terms of age and gender and will receive a neutral insole with a zero-degree inclination.

Osteoarthritis symptoms, EKAM, Cop, Coordination

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.

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.

This file is confidential.