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IRCT20251224068432N1 IRCT 2026-06-23 Razi University The effect of motor imagery and transcranial direct current electrical stimulation combined with neuromuscular training on functional messages in knee osteoarthritis Comparing the Effects of Motor Imagery and Transcranial Direct Current Stimulation (tDCS) Interventions Combined with Neuromuscular Training on Pain Intensity, Quadriceps Muscle Activity, Gait Pattern, and Range of Motion Using Machine Vision in Women with Knee Osteoarthritis 2026-06-22 anticipated 48 Recruiting https://irct.ir/trial/88325 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be allocated to study groups using block randomization. The unit of randomization in this study is the individual. To maintain a balanced number of participants in each study group and reduce the likelihood of group imbalance, block randomization with equal block sizes will be employed. The random sequence will be generated using Random Number Generator software based on a random number table. The randomization process will be conducted by an individual independent of the research team and assessors to prevent allocation bias, Blinding description: To prevent any potential bias in the results, the study assessor will be blinded, and the assessor will be different from the individual responsible for delivering the interventions. The intervention procedures, including motor imagery, transcranial direct current stimulation (tDCS), and neuromuscular exercises, as well as the assessment methods and participants’ ethical and treatment rights, will be explained by the principal investigator.Random allocation will be performed using a random number table by an individual independent of the research team to prevent allocation bias. The randomization process will be carried out using Random Number Generator software, and each participant’s allocation code will be placed in opaque, numbered envelopes. The envelopes will be opened only at the time of participant entry, after assessments, and by a person other than the assessor to maintain assessor blinding (the assessor will remain unaware of participants’ group allocation and type of intervention).Preliminary screening will be conducted to confirm participants’ ability to participate in the study, and each participant will then be assigned to one of the three study groups. In this study, participants will be randomly assigned to three intervention groups. All interventions will be conducted by the principal investigator. N/A Osteoarthritis of knee. Intervention 1: Intervention group:Participants in this group will participate in a neuromuscular training program for 4 weeks (12 sessions, 3 sessions per week). Each session consists of 60 minutes of neuromuscular training aimed at improving motor control, balance, proprioception, muscle coordination, and knee joint stability. In addition, a guided motor imagery intervention will be performed before the exercises begin. In this section, participants imagine the functional movements and exercises in question without actually performing them, but only mentally and from a first-person perspective. Motor imagery sessions will be performed before the neuromuscular training in each session and will continue throughout the 4-week period. Intervention 2: Intervention group:Participants in this group will participate in a neuromuscular training program for 4 weeks (12 sessions, 3 sessions per week). In addition to the training, they will receive 20 minutes of transcranial direct current stimulation (tDCS) per session. Stimulation will be performed using a NeuroStim 2 device manufactured by Medina Teb Gostar Company, Tehran. The anode electrode will be placed on the primary motor cortex (M1) opposite the affected leg at the C3/C4 position based on the international 20-10 system, and the cathode electrode will be placed on the contralateral supraocular region. The current intensity will be 2 mA, and the stimulation will be applied for 20 minutes. After the stimulation ends, participants will perform neuromuscular training for 60 minutes. Intervention 3: Control group: Participants in this group will receive only the neuromuscular training program for 4 weeks (12 sessions, 3 sessions per week). Each session will consist of 60 minutes of neuromuscular training aimed at improving motor control, balance, proprioception, muscle coordination, and knee joint stability. This group will not receive any additional interventions, including motor imagery or transcranial direct current stimulation (tDCS). No - There is not a plan to make this available Justification or reason for not sharing IPD is To protect participant confidentiality and comply with research ethical considerations, there is no plan to share individual participant data (IPD). Access to the raw data will be restricted to the principal investigators and will be used solely for the purposes of the present study.
public Farzaneh Gandomi
Kermanshah - Basij Crossroads - Opposite Payam Store - Renault Building - First Floor, Unit 1.
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3434 3515 gandomi777@gmail.com Razi University scientific Farzaneh Gandomi
Kermanshah - Basij Crossroads - Opposite Payam Store - Renault Building - First Floor, Unit 1.
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3434 3515 gandomi777@gmail.com Razi University Iran (Islamic Republic of) Patients with unilateral knee osteoarthritis: diagnosed by a specialist physician or physiotherapist, with chronic knee pain lasting at least 3 months and a pain intensity of ≥ 3 out of 10 on the Visual Analog Scale (VAS) .• Radiographic disease severity graded as ≤ II according to the Kellgren–Lawrence scale.• Age range: 40–65 years.• Sex: female.• A minimum score of 24 on the Mini-Mental State Examination (MMSE) to ensure adequate cognitive function .• Ability to participate in intervention sessions and assessment procedures.• Ability to understand and respond to questionnaires and therapeutic instructions.• No use of medications affecting the central nervous system, such as antidepressants or antiepileptic drugs, during the past 4 weeks. 40 years 65 years Female * Age below 40 years or above 65 years.* History of knee surgery or knee joint replacement within the past 6 months.* Neurological, systemic, or inflammatory diseases affecting neuromuscular function, such as multiple sclerosis (MS), rheumatoid arthritis, or uncontrolled diabetes.* Pregnancy or breastfeeding.* Use of medications affecting the central nervous system within the past 4 weeks.* Participation in similar rehabilitation exercises within the past 3 months.* Presence of metal implants or electronic devices in the knee or head region.* History of seizures or epilepsy.* Severe psychiatric disorders (e.g., major depression, schizophrenia, bipolar disorder).* Physical or cognitive inability to properly perform motor imagery or neuromuscular exercises.* Participation in a similar study within the past 6 months.* Skin problems or wounds in the area of electrode placement for tDCS. M17 Osteoarthritis of knee Rehabilitation Rehabilitation Rehabilitation Intervention group:Participants in this group will participate in a neuromuscular training program for 4 weeks (12 sessions, 3 sessions per week). Each session consists of 60 minutes of neuromuscular training aimed at improving motor control, balance, proprioception, muscle coordination, and knee joint stability. In addition, a guided motor imagery intervention will be performed before the exercises begin. In this section, participants imagine the functional movements and exercises in question without actually performing them, but only mentally and from a first-person perspective. Motor imagery sessions will be performed before the neuromuscular training in each session and will continue throughout the 4-week period. Intervention group:Participants in this group will participate in a neuromuscular training program for 4 weeks (12 sessions, 3 sessions per week). In addition to the training, they will receive 20 minutes of transcranial direct current stimulation (tDCS) per session. Stimulation will be performed using a NeuroStim 2 device manufactured by Medina Teb Gostar Company, Tehran. The anode electrode will be placed on the primary motor cortex (M1) opposite the affected leg at the C3/C4 position based on the international 20-10 system, and the cathode electrode will be placed on the contralateral supraocular region. The current intensity will be 2 mA, and the stimulation will be applied for 20 minutes. After the stimulation ends, participants will perform neuromuscular training for 60 minutes. Control group: Participants in this group will receive only the neuromuscular training program for 4 weeks (12 sessions, 3 sessions per week). Each session will consist of 60 minutes of neuromuscular training aimed at improving motor control, balance, proprioception, muscle coordination, and knee joint stability. This group will not receive any additional interventions, including motor imagery or transcranial direct current stimulation (tDCS). Knee joint pain severity based on visual analog scale (VAS) score. Timepoint: Measurement of knee joint pain intensity at two time points; once at the beginning of the study (pre-test and before the start of the intervention) and once after the end of 4 weeks of intervention and completion of 12 training sessions (post-test). Method of measurement: The visual pain scale consists of a 10-centimeter line, one end of which indicates "no pain" and the other end indicates "the most severe pain imaginable," and the intensity of the pain is determined by the individual on this scale. Quadriceps electrical activity based on the amplitude of the signal recorded from the quadriceps muscles during functional activities including walking, climbing stairs, and sitting and standing. Timepoint: Measurement of the electrical activity of the quadriceps muscle in two stages: before the start of the intervention (pre-test) and after the completion of the four-week intervention period and 12 training sessions (post-test). Method of measurement: The Nuraxon wireless surface electromyography device uses disposable surface electrodes and records the electrical signal of the quadriceps muscles during functional activities. Knee joint range of motion based on knee joint flexion and extension angles during the sit-to-stand test, measured through video image analysis. Timepoint: Measurement of knee joint range of motion in two stages: before the intervention (pre-test) and after the completion of the four-week intervention period and 12 training sessions (post-test). Method of measurement: Digital filming of the sit-to-stand test and image analysis using an image processing method based on an algorithm to detect key body points in order to extract the angle of knee joint flexion and extension. Gait pattern based on lower limb kinematic parameters including knee joint motion angles while walking on a treadmill. Timepoint: Gait pattern measurement in two stages: before the intervention (pre-test) and after the completion of the four-week intervention period and 12 training sessions (post-test). Method of measurement: Digital video recording of the subject's walking on a treadmill and analysis of kinematic parameters using Kinovia motion analysis software. Physical performance score of patients with knee osteoarthritis based on the Osteoarthritis Index questionnaire from Western Ontario and McMaster Universities. Timepoint: Before the start of the intervention (pre-test) and after the completion of the four-week intervention period (post-test). Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire. The level of fear of movement and physical activity related to knee pain based on the score of the agoraphobia questionnaire. Timepoint: Before the start of the intervention (pre-test) and after the completion of the four-week intervention period (post-test). Method of measurement: Tampa Agoraphobia Questionnaire. The degree of perceived instability of the knee joint based on the score of the Knee Instability Questionnaire. Timepoint: Before the start of the intervention (pre-test) and after the completion of the four-week intervention period (post-test). Method of measurement: Knee joint instability questionnaire. Razi University Approved 2026-06-06 Ethics committee of Razi University Razi University, Taq Bostan, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)