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IRCT20160423027554N3 IRCT 2023-03-25 Esfahan University of Medical Sciences The effects of transcranial direct current stimulation on static balance in people with knee osteoarthritis The effects of transcranial direct current stimulation on static balance in people with knee osteoarthritis 2023-05-22 anticipated 26 Complete https://irct.ir/trial/22545 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: This study does not have a control group. All participants will be exposed counterbalanced randomly to two experimental conditions, including real tDCS and sham tDCS with a one-week washout period. All participants will be randomly assigned (1:1), using a web-based randomisation system (http://www.randomization.com), to receive real and sham tDCS, based on the block randomization method, in which the block size is 2 and the number of blocks is 13. The researcher who assigns the volunteers to groups based on the random list is different from the researcher who performs the treatment, Blinding description: The participants will be masked to the stimulation condition. A researcher (assessor), unaware of the stimulation conditions (real and sham), will assess static balance in two conditions of open and closed eye, before and after the interventions (real and sham). N/A Knee Osteoarthritis. Intervention 1: Intervention group: real tDCS: َAll participants will be received real and sham tDCS with a counterbalanced crossover design within a one-week interval. The electrode montages for the sham and real tDCS conditions are identical. The anode electrode will be place on the vertex (Cz based on the 10-20 system) and the return electrode will be fixed centrally over the supraorbital area. The intensity and duration of real tDCS will be 2 mA and 20 minutes, respectively. This study does not have a control group. Intervention 2: Intervention group: sham-tDCS: َAll participants will be received real and sham tDCS with a counterbalanced crossover design within a one-week interval. The electrode montages for the sham and real tDCS conditions are identical. The anode electrode will be place on the vertex (Cz based on the 10-20 system) and the return electrode will be fixed centrally over the supraorbital area. For sham-tDCS, stimulation will be conducted for 30 seconds, and then the stimulator will be turned off without the participant’s awareness. This study does not have a control group. 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 I have not decided yet
public Dr Zohreh Shafizadegan
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5007 z.shafizadegan@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Zohreh Shafizadegan
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5007 z.shafizadegan@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age of 45–70 years Radiological signs of mild to moderate knee osteoarthritis according to K-L scale Pain and tenderness in medial side of knee joint (VAS > 3) Walking without use of assistive devices 45 years 70 years Both Obesity with body mass index (BMI) >30 kg/m2 Any neurological disorders that would influence balance Taken medication that affects balance control Previous knee injury or surgery / prior arthroplasty of any joint of lower extremity Fracture of either lower extremity within 6 months Any congenital or acquired musculoskeletal disorder in lower extremity Presence of any inflammatory arthritis Any contraindication to apply tDCS such as head implants, history of epilepsy/seizure or brain tumors, and pregnancy M17 Osteoarthritis of knee Rehabilitation Placebo Intervention group: real tDCS: َAll participants will be received real and sham tDCS with a counterbalanced crossover design within a one-week interval. The electrode montages for the sham and real tDCS conditions are identical. The anode electrode will be place on the vertex (Cz based on the 10-20 system) and the return electrode will be fixed centrally over the supraorbital area. The intensity and duration of real tDCS will be 2 mA and 20 minutes, respectively. This study does not have a control group. Intervention group: sham-tDCS: َAll participants will be received real and sham tDCS with a counterbalanced crossover design within a one-week interval. The electrode montages for the sham and real tDCS conditions are identical. The anode electrode will be place on the vertex (Cz based on the 10-20 system) and the return electrode will be fixed centrally over the supraorbital area. For sham-tDCS, stimulation will be conducted for 30 seconds, and then the stimulator will be turned off without the participant’s awareness. This study does not have a control group. Static Balance. Timepoint: Before and after the intervention. Method of measurement: Measurement of static balance parameters using the force plate. Strength of the quadriceps and hamstring muscles. Timepoint: Before and after the intervention. Method of measurement: Dynamometer. Pain intensity. Timepoint: Before and after the intervention. Method of measurement: Visual Analog Scale (VAS). Esfahan University of Medical Sciences Approved 2023-02-21 Research ethics Committees of Isfahan University of Medical Sciences and Health Services Hezar Jarib Street, Isfahan University of Medical Sciences, Isfahn. Isfahan Isfehan Iran (Islamic Republic of)