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IRCT20250903067109N1 IRCT 2026-01-31 Shahid Beheshti University of Medical Sciences effects of functional virtual reality intervention on biomechanic indexes and proprioception after high tibial osteotomy operation effects of functional virtual reality intervention on biomechanic indexes and proprioception 6 month after high tibial osteotomy operation 2026-02-20 anticipated 28 Complete https://irct.ir/trial/86566 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a stratified block randomization method will be used. Participants will first be stratified based on their Body Mass Index (BMI) to control for its potential confounding effect on the study outcomes. Within each BMI stratum, randomization will be performed using block of four to ensure balanced allocation between the intervention and control groups. The allocation sequences within each block will be randomly generated using Random Allocation Software, with a fixed block size of 4. The randomization and allocation process will be conducted by an independent researcher who is not involved in date collection or intervention implementation, Blinding description: This study will be conducted in a double-blind design. In this trial, both the participants and the outcome assessors will be blinded to the type of intervention received. Allocation to the intervention and control groups will be performed using coded randomization, and each participant will receive a unique identification code. The intervention will be prepared or presented in identical forms to prevent any visual or procedural differences between groups. The allocation codes will remain concealed from the principal investigator and data analyst until the completion of data analysis and will only be disclosed in case of serious adverse events requiring unblinding. N/A post-operative rehabilitation of patients with high tibial osteotomy.. Intervention 1: Intervention group: The intervention group will perform routine rehabilitation interventions in addition to virtual reality exercises aimed at improving balance, proprioception, and postural stability, which are designed and programmed by the researcher and executed using a virtual reality device, for 4 weeks, with 3 sessions of 45 minutes each per week. In this group, in addition to routine balance rehabilitation interventions, interventions using the SENA intelligent rehabilitation system at the Red Crescent Comprehensive Rehabilitation Center and the related device will also be carried out. The Kinect camera of this tool determines the patient's joint angles and presents them as an avatar on the screen, providing various dynamic balance exercises. Using the balance board, which is connected to the device via a cable, also enables static balance exercises. During the exercises, a target is usually set for the patient, represented by colored balls, and the patient hits the targets by moving their feet or shifting their center of gravity. The size of the target, the time to reach it, and the number of hits can change the level of the games and determine the difficulty of the exercises according to the therapist's judgment and the patient's progress. Additionally, during the exercises, appropriate auditory and visual feedback is provided through the display based on the individual's performance. Intervention 2: Control group: In the control group, patients receive routine rehabilitation exercises in addition to balance and proprioception exercises such as standing and walking on uneven surfaces, postural stability exercises, and gait training exercises with similar repetition and intensity for 4 weeks, three 45-minute sessions per week under the supervision of a trained occupational therapist. Routine rehabilitation includes full weight bearing on the affected knee, strengthening the muscles around the knees, especially the vastus medialis and quadriceps, lateral and forward step-up exercises, weight transfer exercises from one leg to the other using a foam roll and balance board, walking on the foam roll, and other uneven surfaces. 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 Data collection has not been don yet, if all patients are satisfied, there is a plan to release it.
public Reyhane Zare
Shahid Beheshti Faculty of Rehabilitation Science, in front of Bu Ali hospital, Damavand street
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 reyhane.zare@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reyhane Zare
Shahid Beheshti Faculty of Rehabilitation Science, in front of Bu Ali hospital, Damavand street
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 reyhane.zare@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Performing proximal tibial osteotomy surgery for the first time unilateral surgery homogenity of groups in terms of surgical method and the time elapsed since surgery Patients should be in the age range of 30-50 years Willingness to participate in research and understand information related to the research content ability to answer the questions in persian Cognitively, being in the 24-30 range based on the MMSE scale Ability to walk and maintain balance while standing without any assistive device At least 3 months and at most one year should have passed since the surgery. No complications after surgery, such as non-union, delayed union, and infection No neurological problems No accompanying neurological diseases or other orthopedic disorders that impair balance. Avoid using balance-disrupting medications during the assessment and intervention period No other surgery on the lower limb in the past year 30 years 50 years Both Damage to the operated bone such that a second surgery is required. The presence of issues such as embolism that have disrupted the normal course of treatment Unwillingness to continue cooperation M21.16 Varus deformity, not elsewhere classified, knee Rehabilitation Rehabilitation Intervention group: The intervention group will perform routine rehabilitation interventions in addition to virtual reality exercises aimed at improving balance, proprioception, and postural stability, which are designed and programmed by the researcher and executed using a virtual reality device, for 4 weeks, with 3 sessions of 45 minutes each per week. In this group, in addition to routine balance rehabilitation interventions, interventions using the SENA intelligent rehabilitation system at the Red Crescent Comprehensive Rehabilitation Center and the related device will also be carried out. The Kinect camera of this tool determines the patient's joint angles and presents them as an avatar on the screen, providing various dynamic balance exercises. Using the balance board, which is connected to the device via a cable, also enables static balance exercises. During the exercises, a target is usually set for the patient, represented by colored balls, and the patient hits the targets by moving their feet or shifting their center of gravity. The size of the target, the time to reach it, and the number of hits can change the level of the games and determine the difficulty of the exercises according to the therapist's judgment and the patient's progress. Additionally, during the exercises, appropriate auditory and visual feedback is provided through the display based on the individual's performance. Control group: In the control group, patients receive routine rehabilitation exercises in addition to balance and proprioception exercises such as standing and walking on uneven surfaces, postural stability exercises, and gait training exercises with similar repetition and intensity for 4 weeks, three 45-minute sessions per week under the supervision of a trained occupational therapist. Routine rehabilitation includes full weight bearing on the affected knee, strengthening the muscles around the knees, especially the vastus medialis and quadriceps, lateral and forward step-up exercises, weight transfer exercises from one leg to the other using a foam roll and balance board, walking on the foam roll, and other uneven surfaces. Static balance. Timepoint: The begining of the study before intervention and 4 weeks after using the intervention. Method of measurement: force plate. Dynamic balance. Timepoint: The begining of the study before intervention and 4 weeks after using the intervention. Method of measurement: STAR test. Quality of life. Timepoint: The begining of the study before intervention and 4 weeks after using the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score questionaire (KOOS). Shahid Beheshti University of Medical Sciences Approved 2024-11-10 Vice-chancellor in research afairs- Shahid Beheshti University of Medical Sciences Shahid Beheshti university of medical Science, arabi St., Daneshjoo Blvd., velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)