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IRCT20200203046360N1 IRCT 2020-05-30 Shahid Beheshti University of Medical Sciences effect of whole body vibration on muscle inhibition study effect of whole body vibration on arthrogenic muscle inhibition of quadriceps muscle in knee osteoarthritis patients 2020-06-09 anticipated 30 Complete https://irct.ir/trial/45549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: First, when the sampling is done in a simple and accessible way, each sample is given a specific code, then each code is written on a piece of paper and the papers are poured into a container, the number of samples of each group is drawn and The number of papers randomly leaves the container, Blinding description: Keeping participants blind so that patients in the intervention group are visited on even days and the control group is visited on individual days, and each group is unaware of the existence of the other group. Keeping blind variables assessor in such a way that at the time of testing the variables, the assessor is unaware of the type of group therapy and only measured the variables in all participants. Keeping the data analyst blind so that he is unaware of each patient's treatment group at the time of reviewing and analyzing the data, and each patient is introduced to the analyzer with only one identifier code. N/A knee osteoarthritis. Intervention 1: Intervention group: whole-body vibration group Vibration frequency: Hz 30/ Vibration amplitude: mm 4 (peak to peak)/ Vibration type: Vertical vibration/ Vibration acceleration: g8.24/ Exercise position: standing, with 30 degrees of flexion, without socks and shoes/ exercise duration: 30 seconds/ Rest duration Between Each Exercise: 60 Seconds/ Number of repetitions in each set: 4 times/ Number of sets: 2 to 4 sets (first, second and third sessions 2 sets / fourth, fifth and sixth sessions 3 sets / seventh, eighth, ninth and tenth sessions 4 sets)/ Rest duration between each set: 5 minutes Routine physiotherapy treatment includes: 20-minute electrical stimulation / 5-minute ultrasound therapy and quadriceps muscle strengthening exercises. Intervention 2: Intervention group: placebo Use the whole body vibration device for 4 sets of 30 seconds per set and rest for 60 seconds between each set while the device is off and has no vibration. Routine physiotherapy treatment includes: 20-minute electrical stimulation / 5-minute ultrasound therapy and quadriceps muscle strengthening exercises. Intervention 3: Control group: control Routine physiotherapy treatment includes: 20-minute electrical stimulation / 5-minute ultrasound therapy and quadriceps muscle strengthening exercises. Yes - There is a plan to make this available What will be shared: may share the main results of the study When: after the end of the study in1399 To whom: for the academic researchers Conditions: analysis results in each group are able to represent as tables and graphs Where to obtain: The main presenter, Dr. Khosrow Khademi Kalantari, Professor, Department of Physiotherapy, Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences How to obtain: After submitting a written request to the main executor and stating the reason for the data request, if the main executor is approved, the data file will be provided as needed. Comments:
public Khosro Khademi-Kalantari
Dep of Physiotherapy, School of Rehabilitation Sciences, Shahid Beheshti UN of Medical Sciences
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 khosro_khademi@yahoo.co.uk Shahid Beheshti University of Medical Sciences scientific Khosro Khademi-Kalantari
Dep of Physiotherapy, School of Rehabilitation Sciences, Shahid Beheshti UN of Medical Sciences
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 khosro_khademi@yahoo.co.uk Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients with primary knee osteoarthritis in grade2 or 3 based on kellgren and lawrence criteria patients with chronic knee pain (feeling pain in knee or around of it in most of the time, feeling pain in knee for recent year) age range between 30 and 60 no participant in strengthening program from 6 month ago BMI between 22 and 30 having at least 10% arthrogenic muscle inhibition in quadriceps muscle of affected knee 30 years 60 years Both severe cardiovascular disease which prevents exercising drug addiction total knee arthroplasty or any other surgery on lower limb pain score more than 5 based on VAS during study knee surgery history , rheumatoid disease or septic knee , cancer secondary osteoarthritis M15.0 Primary generalized (osteo)arthritis Rehabilitation Rehabilitation Rehabilitation Intervention group: whole-body vibration group Vibration frequency: Hz 30/ Vibration amplitude: mm 4 (peak to peak)/ Vibration type: Vertical vibration/ Vibration acceleration: g8.24/ Exercise position: standing, with 30 degrees of flexion, without socks and shoes/ exercise duration: 30 seconds/ Rest duration Between Each Exercise: 60 Seconds/ Number of repetitions in each set: 4 times/ Number of sets: 2 to 4 sets (first, second and third sessions 2 sets / fourth, fifth and sixth sessions 3 sets / seventh, eighth, ninth and tenth sessions 4 sets)/ Rest duration between each set: 5 minutes Routine physiotherapy treatment includes: 20-minute electrical stimulation / 5-minute ultrasound therapy and quadriceps muscle strengthening exercises Intervention group: placebo Use the whole body vibration device for 4 sets of 30 seconds per set and rest for 60 seconds between each set while the device is off and has no vibration. Routine physiotherapy treatment includes: 20-minute electrical stimulation / 5-minute ultrasound therapy and quadriceps muscle strengthening exercises Control group: control Routine physiotherapy treatment includes: 20-minute electrical stimulation / 5-minute ultrasound therapy and quadriceps muscle strengthening exercises Arthrogenic muscle inhibition of quadriceps. Timepoint: before any intervention, after first session, end of ten session , one month follow up. Method of measurement: quantitative measurement using digital dianamometer. Maximal voluntary isometric contraction. Timepoint: before any intervention, after the first session, end of ten-session, one month follow up. Method of measurement: quantitative measurement of muscle strength using digital dinamometer. Pain. Timepoint: before any intervention, after the first session, end of ten-session, one month follow up. Method of measurement: using VAS. Function. Timepoint: before any intervention, after the first session, end of ten-session, one month follow up. Method of measurement: using 6 minute waking test. Balance. Timepoint: before any intervention, after the first session, end of ten-session, one month follow up. Method of measurement: using berg balance scale. Quality of life. Timepoint: before any intervention, after the first session, end of ten-session, one month follow up. Method of measurement: using WHO-QOL brief questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-01-26 Ethics committee of shahid behshti medical university next to Ayatollah Taleghani Hospital, Shahid Arabi St., Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)